International regulatory news in brief

Image with the word 'Regulations'

This post covers international regulatory news in brief. It is updated on an ad hoc basis.

For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab. Click on the respective tab to view the news for that region/topic.

Switzerland
1 August 2026
Changes to the guidance document RMP ICH E2E information submission HMP

The guidance document RMP ICH E2E information submission HMP has been comprehensively revised, in particular the requirements as regards the publication of officially mandated information material on the central electronic publication platform have been defined.

Officially mandated information material makes an important contribution to medicinal product and patient safety. Since 1 July 2025, this officially mandated information material must be identified with a special symbol: “Blue safety information”.

  • The framework conditions for the central electronic publication of these officially mandated information materials have now been published in the current revision of the guidance document RMP ICH E2E information submission HMP.
  • The aim is to give healthcare professionals, patients and carers access to the full, up-to-date information at all times.

The revised guidance document RMP ICH E2E information submission HMP enters into force on 1 August 2026.

The document Questions and answers – Risk management has also been revised in accordance with the guidance document and further updated, and likewise comes into effect from 1 August 2026.

Further detailed information is available at the link below.

Source: Swissmedic

Adaptation of questions and answers and guidance to mobile technologies

Swissmedic has revised the routing of mobile technologies and the Q & A on mobile technologies and has specified the requirements for the use of QR codes on drug packages.

  • In practice, more and more questions have been raised about the implementation of the requirements with regard to the indication and placement of the URL, the placement of the QR code and the designation of the QR code.
  • Against this background, Swissmedic has revised the guidance of mobile technologies.
  • The aim of the adaptation is to specify which elements are mandatory and which are considered a recommendation.
  • It was clarified that aspects such as the use of a URL and the designation of the QR code with a reference such as «medical information» are designed as recommendations.
  • In addition, questions have arisen about the linking of QR codes to certain platforms for the publication of drug information.
  • Against this background, the questions and answers on mobile technologies have been supplemented with two new questions.
  • The adapted route mobile technologies is valid from 1 August 2026.
  • The two new questions and answers about mobile technologies will also be available on our website from 1 August 2026.

Source: Swissmedic

Leaflet guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway updated

The information leaflet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway has been updated.

The revision takes into account in particular the completion of the reporting process via the gateway from E2B(R2) to E2B(R3) and the requirements of the GVP Module VI Addendum II.

With version 2.0, the following adjustments were made:

  • Update of the requirements and processes for the electronic transmission of Individual Case Safety Reports (ICSRs) after completion of the changeover to E2B(R3) on the gateway
  • Supplementation and clarification of the requirements for electronic reporting, including reporting requirements, patient identifiers, literature references and attachments
  • Recording of requirements for the use of NullFlavor flags according to GVP Module VI Addendum II
  • Clarification of organizational requirements in connection with electronic reporting when several authorisation holders report from a PV database (use of a common transmitter ID)

In addition, further editorial adjustments and substantive clarifications were made in all chapters.

The updated information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway comes into force on 1 August 2026.

Source: Swissmedic

14 July 2026
Implementation of eCTD v4.0

eCTD v4.0 is a technical standard developed by the ICH for the submission of authorisation applications for medicinal products. It is an upgraded version of the current eCTD v3.2.2 standard on which Swissmedic’s current eCTD solution is based.

  • Swissmedic will complete technical implementation of eCTD v4.0 by the end of 2026, after which the standard will go live during 2027 once pilot testing has been completed.
  • The aim is to ensure international compatibility with other regulatory authorities in terms of the requirements for authorisation applications.
  • The current eCTD v3.2.2 standard will initially continue to be supported throughout a transitional phase lasting several years.
  • Swissmedic is now publishing version 1.1 of the package for the Swiss Implementation Guide.
  • This sets out the technical requirements and serves as a basis for developing software applications for the generation of valid submissions in Switzerland.
    • The package for the Swiss Implementation Guide comprises:
    • Implementation Guide (IG) v1.1
    • Lists of the required controlled vocabulary (CV) v1.1
    • Validation Criteria v1.1
  • The documents in question can be downloaded here as a zip file.
  • The requirements will be continuously refined and updated as development of Swissmedic’s eCTD review solution progresses.
  • Further versions will be published if necessary.
  • A final version (2.0) is scheduled for the start of 2027 at the latest.
  • In addition, a list of FAQs will be published in spring 2027 once the pilot studies have been completed.
  • Swissmedic will provide continual updates on progress.
  • Suggestions and feedback – particularly concerning the technical documents in the package for the Swiss Implementation Guide – can be submitted through the appropriate contact channels at any time.

Source: Swissmedic

1 July 2026
TPLRO, TPLO: Update of annexes

Over the past few months, the following list published by Swissmedic has been updated and revised accordingly taking into account the current status of science and technology, on the basis of the various reports received and in keeping with the legal requirements and specifications,

  • Annexes 3a of the Therapeutic Products Licensing Requirements Ordinance
    (TPLRO), and
  • Annex 3 of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO)

At a meeting of Swissmedic’s Agency Council on 17 April 2026 following the conclusion of the consultative process involving subject-matter experts and official bodies, it was decided that the annexes to TPLRO and TPLO should be amended with effect from 1 July 2026.

The following annexes are affected:

  • Annex 3a TPLRO Pharmaceutical excipients of particular interest,
  • Annex 3 TPLO Medicinal products and medicinal product groups with a manufacturing process subject to mandatory authorisation.

Source: Swissmedic

19 June 2026
Revision of the Swissmedic Fees Ordinance on 1 July 2026

The revised Ordinance on the Fees charged by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic; SR 812.214.5) enters into force on 1 July 2026.

  • As announced in the Federal Council media release on 28 May 2026, the revision includes, in particular, the introduction of a registration fee for medical devices and an increase in the rate for work charged on an hourly basis.
  • In this communication, Swissmedic clarifies the implementation of the revision.

Source: Swissmedic

18 June 2026
Revised annex 3a TPLRO

On 1 July 2026, the revised Annex 3a of the Ordinance on the Licensing Requirements for Therapeutic Products (TPLRO) will enter into force.

  • Polysorbates are newly listed as excipients of particular interest for parenteral and topical use.
  • Polysorbates are widely used as excipients, particularly in biological and biotechnological medicinal products.
  • MA holders of human medicinal products must review their product information texts and packaging materials for compliance with the new requirements and submit any necessary amendments to Swissmedic (variation E.100 b), type IB).

Source: Swissmedic

1 June 2026
Changes to the Project Orbis guidance document

Swissmedic has revised the Project Orbis guidance document.

  • In particular, the process for applications for the Project Orbis procedure is described in greater detail.
  • The structure of the guidance document has also been modified as part of updating, and editorial changes have been made in various sections to improve clarity.
  • The modifications that have been made do not constitute changes to the requirements for applications for the Project Orbis procedure.
  • The revised Project Orbis guidance document takes effect from 1 June 2026.
1 May 2026
FAST-Track Pilot-Project for clinical trials

From 1 May 2026 onwards submissions for clinical trials with medicinal products of categories B and C, which have received confirmation for an accelerated review by Swissmedic upfront, will also be evaluated by the respective ethics committee in an accelerated manner.

  • The application for a Swissmedic FAST-Track procedure should be mentioned when submitting the clinical trial project on the BASEC Portal to make this happen.
  • With this harmonised accelerated procedure participants of clinical trials will benefit from the possibility to be faster enrolled into the authorised clinical trials.
  • More information can be found on the swissethics homepage.

Source: Swissmedic

Turkey
31 July 2026
Guideline on the Naming of Human Medicinal Products updated

In order to provide guidance to owners and to determine the procedures and principles for the evaluation of names for human medicinal products to be performed out by TITCK, the “Guideline on the Naming of Human Medicinal Products” has been revised and published in accordance with current requirements. 

You can view the updated guideline and its appendices via this link.

Guideline for Evaluating Batch Size of Human Medicinal Products in Solid Oral Dosage Forms Before Licensing Application updated

The “Guideline for Evaluating Batch Size of Human Medicinal Products in Solid Oral Dosage Forms Before Licensing Application” has been revised and published in line with current requirements.

You can view the updated guideline here.

Source Titck

22 July 2026
Update to The “Guidelines on Variations in Licensed Medicinal Products for Human Use”

These guidelines have been updated and published. You can view them here.

Source: TITCK

21 July 2026

In accordance with the Ministerial Decree dated 21/07/2026 and numbered E-97206445-020-322149641, it has been made possible to implement Type IB and Type II variations for human medicines submitted to TITCK before the date of the aforementioned Ministerial Decree, excluding variations to change product names or indications and dosages, without waiting for notification from TITCK.

The application is implemented under the following conditions:

  • The application is carried out at the request and responsibility of the applicant.
  • All technical, administrative, legal, and criminal liabilities that may arise during or after the implementation of the variationapply entirely to the applicant.
  • TITCK reserves the right to evaluate the application, request additional information and documents, and reject the application if deemed necessary;
  • If the variation is found unsuitable as a result of the evaluation, the applicant shall immediately cease implementing the changes. 

Source: TITCK

25 June 2026
Variations update

On 23 March 2026, the “Guidelines on Variations in Licensed Human Medicinal Products” were updated and published on the TITCK website. Variation notifications/applications submitted to TITCK as of this announcement date but not yet evaluated will be assessed in accordance with the updated guidelines.

Source: Titck

6 June 2026
Guidelines for scheduling applications for licensing of human medicinal products

Revision 4 (June 2026) of these guideline has been published. You can view them here.

Source: Titck

20 May 2026
Updated guidelines on clinical research

The Regulation on Clinical Trials of Human Medicinal Products was published in the Official Gazette dated May 27, 2023, and numbered 32203, and entered into force.

  • The “Regulation Amending the Regulation” related to the aforementioned Regulation was published in the Official Gazette dated June 5, 2025, and numbered 32921, and entered into force.
  • In order to ensure compliance with international standards in safety reporting conducted in clinical trials, the National SUSAR Module has been developed as a sub-module within the Clinical Trials Module; accordingly, the “Guideline on Safety Reports in Clinical Trials” has been updated (see below).
  • In light of these developments, there was a need to update the “Guidelines Regarding Clinical Research Applications Submitted to the Turkish Medicines and Medical Devices Agency, Department of Clinical Research” and the “Guidelines Regarding Clinical Research Applications Submitted to Ethics Committees”.
  • The updated guidelines were published and entered into force on May 15, 2026.
  • These guidelines can be accessed at the link below.

Source: Titck

The national SUSAR Module and Guidelines on Safety Reports in Clinical Trials

In order to ensure compliance with international standards in clinical trial safety reporting, TITCK has developed the national “SUSAR Module” as a sub-module of the Clinical Trials Module.

  • This module will enable the collection, recording, creation of a national database, and analysis of individual safety reports generated in clinical trials conducted in Turkey
  • The National SUSAR Module has been developed in accordance with the requirements of ICH E2B(R3): Electronic Transmission of Individual Case Safety Reports and EU Directive 536/2014.
  • Within this scope, the “Guidelines on Safety Reports in Clinical Trials” have been updated and published, entering into force on 15 May 2026.
  • Notifications regarding SUSARs occurring in clinical trials conducted in Turkey can be submitted in XML format via the “SUSAR Module” or in PDF format using the CIOMS form via the “Clinical Trials Module” until July 1, 2026.
  • From 1 July 2026 onwards, notifications will only be accepted in XML format via the “SUSAR Module”. 
  • To ensure the uninterrupted and controlled reporting processes for SUSARs occurring abroad, these reports must be submitted in 6-month periods as sequential lists through the Clinical Trials Module.
  • The attached sample sequential list must be prepared in English, with all relevant fields filled out completely, separately for each research product.
  • The prepared lists should be sent to kagb@titck.gov.tr, specifying the research product name and date range in the email subject line.
  • Furthermore, these lists must be submitted to the Institution in PDF format via the EBS-ESY Clinical Trials Module, selecting the application document type “Safety Report: Serious Unexpected Suspected Adverse Reaction (SUSAR) 6-month Sequential List Report”.
  • A single report per research product is sufficient for this process.

Source: Titck

UK
3 July 2026
Guidance updated: Best practice in the labelling and packaging of medicines

The document Best practice guidance on the labelling and packaging of medicines has been updated.

Source: MHRA

Guidance: Submit changes to labels and Patient Information Leaflets as a self-certification

Additional guidance for submitting changes to labels and patient information leaflets as a self-certification has been published.

Source: MHRA

2 July 2026
Guidance updated: Medicines – apply for a variation to your marketing authorisation

To the section In the section Major variations (Type II), under Variations to add a new therapeutic indication, a new sub-section Deadlines for new therapeutic indication variations has been added.

Source: MHRA

1 July 2026
Guidance updated: Medicines: packaging, labelling and patient information leaflets

A new document with the title Additional guidance for submitting changes to labels and patient information leaflets as a self-certification has been added. You can view it here.

Source: MHRA

25 June 2026
Guidance updated: MHRA Innovation Office: guidance and support

The MHRA has updated this guidance with more information and to improve ease of use. No other specifics have been provided.

The Innovation Office:

  • is open to queries relating to products or technologies that challenge the current regulatory framework, particularly those early in their development phase or in areas of regulatory uncertainty or fields undergoing rapid change.
  • can provide regulatory advice if you are developing a product which uses new or novel technology, materials, methods or approaches or manufacturing processes.

Source: MHRA

9 June 2026
MHRA launches AI sandbox to accelerate medicines development and improve safety

The UK will launch a first-of-its-kind initiative to test how artificial intelligence (AI) can help make medicines safer for patients – as announced by the Science Minister Lord Vallance during London Tech Week today (9 June 2026). 

  • The programme will explore how AI can improve the assessment of accuracy and safety, better predict risks, and detect effects that existing approaches may not capture.  
  • The MHRA will establish a new regulatory “sandbox”, giving companies and researchers a controlled testing environment to work with regulators to explore how AI tools could be used to better understand medicines safety and predict potential side effects.
  • Supported by funding from the UK Government’s Regulatory Innovation Office, the sandbox will allow innovators to test AI tools that have the potential to predict how medicines behave in the body, including how they are absorbed, processed and whether they may cause harm.
  • The programme will also explore how better use of clinical data can improve understanding of how medicines work across different groups, including those often underrepresented in studies such as children, older people and people from diverse backgrounds.

Source: MHRA

8 June 2026
Guidance updated: Clinical trials for medicines: modifying a clinical trial approval

The decision tree to determine the correct category for a modification was updated to reflect that sponsors must begin by determining whether the modification is substantial.

Source: MHRA

20 May 2026
MHRA-NICE Real-World Evidence Scientific Dialogue

The MHRA Real-World Evidence Scientific Dialogue Programme pilot website has been updated to reflect the relaunch of the service and improvements informed by the pilot phase. Key updates include:

  • Updated description of the service offer, providing clearer information on the scope, purpose and eligibility of the updated MHRA-NICE Real-World Evidence Scientific Dialogue (RWE SD)
  • Revised expression of interest process, setting out how applicants can apply to the RWE SD and what to expect at each stage. The expression of interest form can be accessed from 20 May 2026. For the current cycle, expressions of interest for a workshop will be accepted from 20 May 2026 until 17 August 2026. The MHRA will review submissions and notify applicants of the outcome in the first week of October.
  • Improved guidance for applicants, including clearer expectations on the type of questions suitable for discussion
  • General content refresh, including updated language, structure, and accessibility improvements to support ease of use.

These changes support the transition from a pilot to an established service and aim to provide greater clarity and consistency for stakeholders engaging with the programme.

Source: MHRA

12 May 2026
Guidance updated: Borderline products – how to tell if your product is a medicine

MHRA Guidance Note 8: ‘A guide to what is a medicinal product’ is has been replaced with a slightly amended version.

Source: MHRA

European union
27 July 2026

On 12 August 2026, the EU Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40) (the “PPWR”), amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC becomes applicable.

Further useful information is available in the article The EU Packaging and Packaging Waste Regulation: Why Life Sciences Companies Should Act Now, Fabien Roy et al, 27 July 2026, BioSLice Blog, Arnold & Porter.

Belgium
17 July 2026
Update of document on approval dates for variations, renewals and notifications for medicinal products for human use

The document concerning the approval date for variations, renewals and notifications has recently been updated. The changes include a clearer distinction between the revision date and the approval date in the product information for medicinal products for human use.

  • Since 1 June 2026, the revision date and approval date are presented in a new format in the summary of product characteristics (SmPC) and in the patient information leaflet.
  • This procedure applies to the administrative finalisation of a variation, notification or five-yearly renewal resulting in an amendment to the marketing authorisation (MA).

By using two separate dates, a distinction can be made between:

  • the date of the last revision: when the amendment is implemented by the marketing authorisation holder (MAH);
  • the most recent approval date by the FAMHP: when a dossier or cluster of dossiers is administratively closed.

In practice:

  • the MAH enters the date of the last revision in accordance with the guidelines set out in the document’s summary table;
  • in addition, the FAMHP includes ‘FAMHP approval date’ in the product information, making it clear which date was added and by which party.

In addition, the document has been aligned with the latest version of the European Variations Regulation, including the requirement for annual updates, and with other national agreements.

Additional information

Questions and answers

Source: FAHMP

Comment: One can only wonder why this distinction is required because it appears to have no real value beyond the FAHMP monitoring companies to understand the delays in the implementation of updated prescribing information post approval of variations, renewals etc.

7 July 2026
Future European Legislation: State of play

In this post, the FAHMP outlines Belgium’s position on the following evolving legislation:

  • Biotec Act: strengthening innovation through coherent regulation
  • MDR/IVDR: targeted amendments to a complex framework
  • Critical Medicines Act: a crucial step towards a structural approach to addressing shortages
  • European pharmaceutical legislation: towards the final approval of a far-reaching reform

The FAMHP remains actively committed to developing and implementing Belgium’s positions in European forums, with particular attention to striking a balance between competitiveness, public health, security of supply and the quality of regulation.

Source: FAHMP

DG SANTE and EMA
7 July 2026
DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health

DG SANTE and the European Medicines Agency (EMA) have signed a Working Arrangement with New Zealand Ministry of Health incorporating Medsafe this week, to strengthen collaboration and exchange of information on medicinal products.

  • The purpose of this Working Arrangement is to strengthen cooperation between signatories across a range of areas in public health, while promoting the timely, secure exchange of information. Deliverables from the Arrangement will include:
    • Facilitate exchange of information regarding medicinal products quality, safety and efficacy.
    • Increase alignment and coordination on topics related to medicinal products for human-use, in-line with the application legislation.
    • Mutual learning, capacity building and the sharing of best practices in regulatory science and public health.

The Arrangement will run from 6 July 2026.

Source: European Commission

Italy
22 June 2026
Removal of the “/E” suffix from the AIC number of medicinal products authorised through the centralised procedure – Update

In order to harmonise the Italian marketing authorisation (AIC) numbers of medicinal products authorised through the centralised, mutual recognition procedure and decentralised procedure and national procedures, while maintaining the existing coding structure, the suffix “/E”, which is currently appended after the 9 digits identifying the medicinal product pack, is no longer considered necessary and is therefore being removed.

  • The aforementioned suffix is not referred to in the Italian Ministry of Health Decree of 6 March 2025 entitled “Specifiche tecniche dell’identificativo univoco «Data Matrix» dei medicinali ad uso umano”, where the AIC number is specified.
  • Therefore, from the date of publication of this notice on the AIFA website, the suffix “/E” will no longer form part of the AIC number of medicinal products authorised through the centralised procedure and, consequently, will no longer appear on the pharmaceutical sticker (bollino ottico), in the Blue Box, or in administrative acts issued by AIFA.
  • To allow for the necessary implementation of manufacturing processes, IT systems and packaging materials, the use of existing artworks and pharmaceutical stickers bearing the suffix “/E” is permitted until 9 February 2027, as well as the supply disposal of batches already produced/packaged or released by that date till the shelf-life date indicated on the outer/immediate label.
  • Specific cases may be submitted to AIFA for evaluation.
  • Starting 10 February 2027, the suffix “/E” must no longer appear on any identifying element of the medicinal product, including the pharmaceutical sticker and the Blue Box.

Source: AIFA

7 May 2026
Procedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companies

The list of medicines that were recognised as innovative in 2025 has been made available only for marketing authorisation holders of medicines with full innovativeness status.

  • For each product in the list, details are given on the therapeutic indications for which it is authorised and on whether such indications are innovative.
  • The above information is available, starting 7 May 2026, on AIFA’s Front/End platform in the section entitled “Pharmaceutical expenditure payback for direct purchases in 2025”.
  • This section is accessible by companies using the respective credentials, and comments can be submitted no later than 20th of May at 6pm.
  • Marketing authorisation holders are therefore asked to check and, if necessary, correct/supplement the information contained in the files in accordance with the instructions laid down in the Annex entitled “Allegato 1 – Istruzioni per la compilazione”.
  • In order to download the files, access the web platform https://www.agenziafarmaco.gov.it/aifarsf/login or alternatively, you can proceed from the AIFA Online services https://servizionline.aifa.gov.it/ and then select the option “Monitoraggio spesa farmaceutica” in the “Consumi e spesa farmaceutica” section.

Source: AIFA

Spain
13 May 2026
AEMPS publishes the instructions for the use of QR codes in the package leaflet and/or labelling of the medicinal products

AEMPS has published the instructions for the use of QR codes in the package leaflet and/or labelling of medicines authorized by national procedure (NAPs), decentralized (DCPs) or mutual recognition (MRPs).

  • The purpose of this document is to establish the applicable conditions and procedures for the inclusion of QR codes as a way of accessing the drug information.
  • QR codes can be used to link to statutory product information (product information, risk prevention tools, etc.) or other supplementary information.
  • The instructions detail the national and European procedures (MRP/DCP) to be followed by marketing authorisation holders (MAHs) depending on the type of amendment they wish to introduce.
  • They also specify the presentation requirements and the necessary documentation when the inclusion of the QR code is processed by communication or variation.
  • They also report on the procedure to be followed for the inclusion of the NaviLens code and the information contained in the QR in other languages.
  • In addition, they clarify that the presentation of a communication does not entail the payment of fees, although it does require the sending of an electronic sequence that includes, among other documents, a cover letter and the new modified materials.
  • These instructions have been developed in accordance with the document CMDh position paper on the use of mobile scanning and other technologies to be included in the labelling and/or leaf packagelet in order to provide information about the medicinal product, prepared by the Coordination Group on Mutual and Decentralized Recognition Procedures (CMDh) and recently updated.
  • For the use of QR codes in medicinal products authorised by centralised procedure, the scanning guide Mobile and other technologies in the labelling and package leaflet of centrally authorised medicinal products should be consulted.

Source: AEMPS

European Commission
12 May 2026
Commission welcomes political agreement on Critical Medicines Act

The European Commission welcomes the landmark political agreement on the Critical Medicines Act (CMA), last night by the Council and the European Parliament.

  • This marks an important milestone in strengthening the resilience of Europe’s health sector by preventing medicine shortages and improving the security of supply of critical medicines across the EU.
  • The CMA:
    • will promote the diversification of supply chains and support pharmaceutical manufacturing within the EU, while enabling Member States to cooperate more closely to improve access to medicines in Europe.
    • complements existing initiatives to address medicine shortages and strengthen supply in the EU, in particular the recently adopted pharmaceutical reform.

The political agreement is now subject to formal approval by the European Parliament and the Council.

Source: European Commission

US FDA
5 August 2026
Reimagining the IND Process through clarifying requirements and launching the Expedited IND Pilot

Clinical trials that take up to two years to complete in the U.S. are being done in 9 months in other countries. That means patients may have to travel abroad for access to investigational therapies, and early-stage investment in science and jobs is moving overseas. 

To address this, FDA is reimagining the IND Process Through Clarifying Requirements and Launching the Expedited IND Pilot — a new model that: 

  • Clarifies IND requirements to reflect what is scientifically appropriate for first-in-human (FIH) Phase 1 trials, prioritizing patient safety while eliminating the ambiguity that drives over-submission
  • Enlists expert Qualified Research Institutions (QRIs) as scientific partners in IND preparation  
  • Introduces rolling review so FDA engages throughout development, not just at the end.

The goal is a faster, more predictable path from scientific discovery to first-in-human trials — without compromising patient safety.

Source: FDA

23 July 2026
Digital Health Technologies (DHTs) for Drug Development

The U.S. FDA announced a funding opportunity, open July 20, 2026 – August 20, 2026, for selected applicants to explore the role of digital health technologies (DHTs) (e.g., actigraphy, photography, contactless sensors) in drug development.

  • Projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups and other stakeholders.
  • The objectives of these projects are to advance DHTs for clinical drug development, expand the ability to capture early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs and enhance convenience for trial participants by allowing for remote data acquisition in clinical investigations. 

The scope includes, but is not limited to, projects that focus on: 

  • Comparing digital measurements to traditional measurements in clinical trials to evaluate drugs 
  • Developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials (e.g., use of contactless room sensors to capture apnea in pediatric patients) 
  • Comparing metrics to evaluate continuous measurements (e.g., maximum activity and stamina) 
  • Capturing early manifestations of chronic diseases (e.g., non-memory related signs of dementia) through the use of DHTs (e.g., tests of balance or slowed reaction time) 

For more information, please see RFA-FD-26-012

Source: FDA

23 July 2026
CMC Development and Readiness Pilot (CDRP) Program

The Strategy Document outlines actions FDA has taken to facilitate chemistry, manufacturing, and controls (CMC) readiness for products with accelerated clinical development timelines.

You can read more about the program at the link below.

Source: FDA

10 July 2026
FDA Proposes Rule to Modernise Drug Manufacturing Registration

The U.S. FDA a proposed rule that, if finalised, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model.

  • The proposed rule would also clarify registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceutical ingredients, that indirectly enter the U.S. drug supply.
  • This action is another step forward in the FDA’s coordinated effort to help ensure Americans have reliable access to safe, quality medicines by strengthening domestic pharmaceutical manufacturing, and ensuring that regulatory frameworks keep pace with innovation.

Distributed manufacturing establishments operate using a “hub-and-spoke” model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations.

  • Currently, regulations require each manufacturing unit in such a network to register separately, creating unnecessary administrative burdens.
  • Under the proposed rule, distributed manufacturing establishments could register as a single establishment.
  • Units could be added, relocated or removed through a streamlined update process, and companies would be required to notify the FDA in advance of any unit relocation, closing a gap in the agency’s real-time oversight.

Source: FDA

9 July 2026
eCTD Submission Standards updates

Source: FDA

25 June 2026
Model-Integrated Evidence (MIE) Industry Meeting Pilot Between FDA and Generic Drug Applicants

FDA’s generic drug program has launched a new pilot program to offer meeting opportunities to prospective generic drug applicants and generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new drug applications (ANDAs).

  • The use of MIE approaches for BE establishment is increasingly prevalent, particularly in the development of challenging products such as long-acting injectables, orally inhaled drugs, and topically applied dermatological products.
  • The primary goal of the MIE Pilot Program is to foster early and focused interactions between industry and FDA on science-driven topics related to MIE approaches for establishing BE in generic drug development.
  • The pilot will facilitate enhanced scientific communication between generic drug developers and FDA, with a specific focus on employing quantitative methods and modeling techniques.

Further information is available at the link below.

Source: FDA

22 June 2026
FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development

The U.S. FDA announced actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials. The FDA’s work is outlined in Operation TrialBlazer, a U.S. Department of Health and Human Services (HHS) initiative.  

The actions are divided into:

1. Early stage actions

The FDA is committed to ensuring the US remains the global standard for pharmaceutical innovation and regulatory rigor for the benefit of American patients and innovators. The agency is eliminating unnecessary regulatory burden, clarifying phase-appropriate requirements, and building partnerships with government, academic medical centers and the private sector.

Early stage actions include the following. Click on each link for further information.

2. Late-Stage Trial Actions 

The FDA is enhancing its guidance for industry to facilitate greater efficiency further along the drug development continuum.

The following guidance is provided:

This HHS roadmap is a coordinated response to a genuine and growing
competitive challenge with real consequences for American patients, industry,
and national security. This roadmap addresses that challenge across six
interconnected areas:

  1. Modernizing regulatory requirement.
  2. Improving transparency for regulated entities.
  3. Encouraging the adoption of more efficient practices.
  4. Ensuring federal funding dollars are spent on adequately powered and designed trials.
  5. Better utilizing existing data sources and technologies for regulatory and data generation purposes.
  6. Improving patient access to clinical trials and removing disincentives
  7. Preventing healthcare workers from being involved in the conduct of research

All of this work is an ongoing, iterative process: The FDA will continue to collaborate, engage stakeholders, and innovate to ensure our guidance remains relevant, science-based, and responsive to the realities of modern drug development.

Further information is also available on the HHS website

Sources: FDA, HHS

5 May 2026
Q&A on Current Good Manufacturing Practice Regulations | Production and Process Controls

The page with the above title has been updated. No information has been provided on the updates.

Source: FDA

Health Canada
12 June 2026
Draft guidance on decentralized clinical trials

Health Canada published the Draft guidance on Decentralized Clinical Trials on December 23, 2025, with a public consultation held until February 21, 2026.

This report summarizes the feedback received during this consultation.

Through this consultation, Health Canada heard a range of perspectives on how to refine the draft guidance and support responsible, practical adoption of decentralized elements.

Most stakeholders strongly supported the draft guidance and the broader adoption of decentralized models, and some identified barriers within the current regulatory framework that could limit use of DCTs. The comments received by Health Canada were grouped into five key themes:

  1. International alignment of terminology and digital technology standards
  2. Risk-proportionate, flexible regulatory pathways
  3. Operational feasibility, administrative burden and practical implementation
  4. Roles, delegation, oversight and inspection boundaries
  5. Participant-centred approaches: Equity, consent and digital access

Further information is available at the link below.

Source: Health Canada

Argentina
15 July 2026
ANMAT simplifies the regulatory framework for post-registration modifications of medicinal specialties of biological origin

ANMAT reports that, from Provision No. 4351/2026, a new comprehensive regulatory framework was approved for the presentation and evaluation of post-registration modifications of medicinal specialties of biological origin.

The move includes products such as vaccines, blood products and other registered biological drugs.

  • The initiative aims to order and simplify the procedures applicable to this type of product since it aligns the technical requirements with international standards of high surveillance, specific clear definitions and establishes maximum resolution deadlines for the different types of procedures.
  • Post-registration changes in a biological medicinal specialty are essential for the continuous improvement of the manufacturing process and to maintain state-of-the-art control of the products in question, such as changes in the composition of influenza vaccines that are modified annually for the circulating strain to be present.
  • It provides for the approval of new procedures for the authorisation of changes related to aspects of quality, safety, efficacy and labeling information (change of the processing site, an extension of the useful life or a new indication of the medicinal product), as well as for the presentation of marketing authorisation extensions.
  • Among the main developments, the standard incorporates a reliance-based evaluation procedure, which will allow consideration of assessments by relevant regulatory authorities, provided that product comparability and background applicability to the national regulatory context are verified. This optimizes analysis times without affecting the autonomy of the organisation.
  • n turn, this mechanism adapts the level of assessment required under a risk-based approach, depending on the impact that the requested modification may have on the quality, safety and efficacy of the drug.
  • This classification establishes categories of modifications (quality, security, labeling, etc.) which allows speeding up the processes for example, to group low risk changes in the same procedure, .
  • Likewise, the provision establishes maximum resolution deadlines for the different types of procedures, with the aim of providing greater predictability to the regulatory and productive planning of the registrants.
  • The new regime comprises seven annexes detailing the general considerations, procedures for each modification category, the classification of changes in quality aspects and the mechanism for the submission of applications through the reliance path.
  • The measure will take effect within 30 working days of publication in the Official Gazette.

Source: ANMAT

15 May 2026
Update of the digital identification system in medicinal specialty packaging

ANMAT reports that, from the Provision 2891/2026, the regulatory framework for the incorporation of two-dimensional codes in the packaging of medicinal specialties is updated, allowing digital access to the package leaflet for the health professional and patient information.

  • The rule establishes the obligation to include two-dimensional codes in the secondary packaging of all medicinal specialties, regardless of their origin, expanding the scope of the current regulation.
  • In this sense, the possibility of using, in addition to Quick Response (QR) codes, other technologies such as Data Matrix, is incorporated, allowing those laboratories that already have this tool to implement it uniformly globally.
  • The measure allows the two-dimensional code to coexist with patient information in paper format, if the lab holder chooses that option.
  • The use of these technologies enables the incorporation of information in a more agile way and in a more friendly format, in clear language or audio, while providing the possibility of adding specific information for the professional, thus facilitating access to updated information in real time, and better control by ANMAT.
  • A period of six months is set for the generation of all the codes, and registrants must have all the QR or Data Matrix codes issued within that period.
  • In addition, a progressive physical implementation schedule is envisaged that includes the exhaustion of the existing stock.
  • By virtue of the entry into force of this new Provision, Provision No. 3294/2025 is terminated and completely replaced by this regulatory framework.

Sorce: ANMAT

Brazil
29 June 2026
Anvisa updates guidelines for evaluation of pharmacokinetic studies of biosimilars

Anvisa published today, the Information Note 1/2026/GGBIO with clarifications on the evaluation of comparative pharmacokinetic studies of biosimilar drugs.

  • According to the new guidance, the evaluation of comparative pharmacokinetic studies presented as a subsidy for the registration of biosimilars and for the approval of Clinical Development Dossiers of Medicines (DDCMs) is carried out by the Biological Product Evaluation Management (GPBIO/GGBIO).
  • The measure is in line with the Resolution of the Collegiate Board (RDC) 875/2024, which provides for the possibility of dispensing of comparative clinical studies of efficacy, provided that certain conditions are met. In this context, the evaluation of pharmacokinetic data plays an even more important role in demonstrating the comparability between biosimilar and its respective comparator product.
  • The Information Note reinforces that companies should continue using the subject codes already planned for the petitioning of these studies:
    • 10846 – Biological Product – Pharmacokinetic study, used at the time of registration of the biosimilar; and
    • 10900 – Clinical trials – Comparative pharmacokinetic studies for biosimilars submitted as DDCM, used for the presentation of studies during the clinical research phase of the drug.
  • In cases where pharmacokinetic studies have already been evaluated by Anvisa during clinical development, it will not be necessary to re-present the same documentation at the time of registration, simply by informing the previously approved protocol in the product dossier.
  • For studies linked to DDCMs, the evaluation will be carried out in a complementary way between GPBIO and the Clinical Research Coordination of Medicines and Biological Products (COPEC), respecting the competencies of each unit.
  • The Note also clarifies that in cases of prioritization of the analysis of DDCMs, both areas should manifest within 45 days after the consent of the prioritization.
  • In addition, the publication revokes previous documents on the topic, updating the guidelines and avoiding overlapping guidelines.
  • With the publication of the Information Note, Anvisa seeks to strengthen the technical evaluation of biosimilars and ensure greater agility in regulatory analysis, without compromising the standards of quality, safety and efficacy of these drugs.
  • The initiative also contributes to giving more clarity to developers and fostering population access to biological treatments.

Source: Anvisa

15 June 2026
Anvisa Updates Normative Instruction and Guides on New Flow to Certification of Good Manufacturing Practices (CBPF)

Normative Instruction (IN) 451/2026, which amends IN 292/2024, was today, introduces relevant changes in the criteria for definition of Equivalent Foreign Regulatory Authorities (AREE) and in the administrative flow for the Certification of Good Manufacturing Practices (CBPF).

  • The update promotes the improvement of the regulatory process with the reorganization of the petitioning and analysis flow, making it more agile, clear and aligned with the international practices and those adopted by the registration area of the Agency itself.
  • Among the advances is the inclusion of a list of AREE at the level of partial or full recognition that now covers decentralized regulatory authorities, allowing the use of inspections conducted by sub-national structures.
  • This new list will be updated according to regulatory flow and simplified procedures.
  • Another important change concerns the administrative flow of petitioning, which should now be filed through addition in the CBPF request and no longer in specific code.
  • This improvement contributes to the organization of processes and to the greater traceability of information, in line with other initiatives of the Agency for qualification of the database and gain of regulatory efficiency.
  • In cases where there is a report issued by the Equivalent Foreign Regulatory Authority, companies should forward the documentation by means of addition to the Certification process, using the appropriate subject codes.

Source: Anvisa

18 May 2026
Anvisa publishes 2nd Report of Inspection Metrics in Good Clinical Practices (BPCs)

Anvisa published the 2nd Report of Inspection Metrics in Good Clinical Practices (BPCs) with information on the main findings identified by the teams of inspectors from 12 inspections carried out in clinical research centers in Brazil, in the years 2024 and 2025.

  • The objective of the inspections is to evaluate the degree of adherence of the centers, sponsors and professionals involved in conducting clinical research to BPCs, according to ICH Guide E6 (R2) or updates, RDC No. 945/2024, Law 14.874/2024 and other regulations related to clinical research.
  • The purpose of BPCs is to ensure the protection of the rights, safety and well-being of clinical research participants, as well as the accuracy and reliability of the results and data obtained to support the sanitary record of medicines by Anvisa.
  • Based on the results addressed in the report, it is observed that there is a strong commitment of the centers and sponsors to conduct clinical research in accordance with the BPCs, providing confidence in the quality of the clinical trials carried out in these centers.
  • In parallel to the report, Anvisa provides a panel with consolidated information on BPC inspections carried out since 2009. Those inspections were temporarily suspended during the Covid-19 pandemic and resumed in 2023.

Source: Anvisa

Mexico
19 June 2026
Abbreviated Regulatory Route (Reliance)

The above is an abridged evaluation procedure in which COFEPRIS recognizes the evaluations carried out by Regulatory Reference Authorities (ARR) to issue the licence in Mexico.

Below is a link to the guidance for the procedure.

Guide to Requirements for the Health Registration of Medical Devices through Abbreviated Equivalence and Regulatory Agreements

Source: Cofepris

New Zealand
4 August 2026
Medsafe has extended the product/packaging types eligible for a general labelling exemption

Following an internal review and risk assessment of current labelling exemptions, Medsafe has extended the product/packaging types eligible for a general labelling exemption.

  • These general labelling exemptions will remain in force until a decision is made to change them, or the relevant labelling requirements in the Regulations are amended.
  • This extension will support patient access to medicines by reducing unnecessary regulatory burden, streamlining Medsafe processes, and promoting harmonisation of regulatory requirements between Australia and New Zealand.

As a consequence of this change, the following have been updated:

More detailed information is available at the link below.

Source: Medsafe

29 June 2026
Guideline on the Regulation of Therapeutic Products in New Zealand – Verification Pathway for New Medicine Applications

Edition 1.0 (July 2026) of the document with the above title has been published.

20 May 2026
Medicines Amendment Act: Verification pathway

The Medicines Amendment Act 2025, which came into force on 19 November 2025, introduced a verification pathway under which medicines can be approved for distribution in New Zealand if they have been approved by two recognised overseas regulatory authorities. 

  • The verification pathway is an additional pathway option for companiesin addition to the two current pathways available to Medsafe.
  • The Act sets out requirements that medicine applications must meet to be considered through the verification pathway.
  • The Act provides that for a medicine to be considered for the verification pathway, it must have full marketing authorisation granted by two or more recognised authorities.
  • The medicine to be supplied in New Zealand must be identical in all material respects to the medicine authorised, with allowance for minor differences.

Further details are available at this link.

Source: Medsafe

Due to the technical nature of the details of the pathway, the Act provides for the operational policies of the pathway to be set out in secondary legislation (rules) made by the Minister of Health.

Australia
24 July 2026
Adoption of International Scientific Guidelines in Australia – R01/2025

The TGA has adopted 23 international scientific guidelines following a public consultation process between 24 November 2025 – 10 February 2026.

You can view them all at the link below.

Source: TGA

18 June 2026
TGA publishes new guidance on advertising restrictions for prescription medicines

The TGA has published new guidance on advertising restrictions for prescription medicines. This is to help individuals and businesses comply with Australia’s regulatory requirements.

  • The guidance, Complying with the restrictions on advertising prescription medicines to the public, is available on the TGA’s website.
  • The guidance provides practical examples to help individuals and businesses to understand their obligations.
  • It explains the types of advertising and promotional activities likely to be prohibited across websites and social media, or in business names and logos, booking systems, product catalogues, price information and other materials.
  • The TGA has also updated its related guidance, Advertising health services that involve therapeutic goods, to address concerns about the promotion of health services to access specific prescription medicines. These services include online and telehealth services.
  • The TGA urges all individuals and businesses supplying, selling or promoting prescription medicines to review their content carefully to ensure it complies with relevant advertising restrictions.
  • The TGA works with industry to support high levels of voluntary compliance in the first instance.
  • Businesses are expected to take prompt action to review and, where necessary, amend or remove content that does not comply with the advertising restrictions.

Source: TGA

India
5 August 2026
Guidance Document on Common Submission Format for Import & Registration of Drug(s) (Bulk & Finished Formulations) in India

Version 1.0 of a guidance document with the above title has been published. Its effective date is 4 August 2026.

This document is a revision of the document Guidance Document on Common Submission Format for Import & Registration of Bulk Drugs and Finished Formulations in India (Document No. IMP/REG/200711).

The document outlines the step-by-step processes from application submission to document evaluation, approval, and post-approval compliance for the import and registration of drugs (for human use) – to ensure uniform and effective implementation of the regulatory provisions prescribed under the provisions of the Drugs and Cosmetics Act, 1940, and Rules, 1945 thereunder.

Source: CDSCO

4 May 2026
Disposal/Rejection of Long Pending Applications on SUGAM Portal Awaiting Query Response

All stakeholders have been reminded that applications pending with applicants for more than two years have already been reminded via the 3 reminder process and will now be rejected after a period of 30 days from the issue of this public notice.

A final rejection communication shall be issued to the concerned applicants.

Source: CDSCO

Malaysia
29 July 2026
Guideline on Application of Manufacturer’s License, Import License and Wholesaler’s License for Registered Products updated

You can view the 4th Edition, of July 2026 here.

Source: NPRA

16 July 2026
Directives for the use of Drug Registration Guidance Document updated

The Third Edition (12th revision July 2026) of the document with the above title is now available.

Source: NPRA

15 May 2026
Directives & Circulars (GCP & GLP)

The following Directives were updated on 15 May 2026:

Source: NPRA

14 May 2026
Guidelines related to GCP & GLP

You can view the updated guidelines here.

Source: NPRA

13 May 2026
Frequently Asked Questions (FAQ) e-labelling

This document was last revised on 13 May 2026. You can view it here.

Source: NPRA

Singapore
30 June 2026
Extension of e-labelling to P and GSL medicines

The Therapeutic Products Branch (TPB) will be extending the application of electronic labelling (e-labelling) to Pharmacy-only (P) and General Sale List (GSL) medicines with effect from 30 June 2026.

  • This is in addition to Prescription-only medicines (POM), for which e-labelling is already applicable.
  • Companies may opt to replace the physical Patient Information Leaflet (PIL) with e-PIL.
  • Please refer to Appendix 7A: Guidance on Electronic Labelling for Therapeutic Products for the eligibility criteria and documentary requirements applicable to P and GSL medicines.

Source: HSA

11 June 2026
Mean application screening response time

HSA’s target screening turn-around-time from the date of receipt of an application dossier to the date of acceptance or non-acceptance/withdrawal of the application (excluding applicant’s response time) is 50 working days (WD).

For new and major variation applications accepted within the period of 01 Oct 2025 to 31 Mar 2026, the mean screening time taken by HSA was:

  • 35.4 WD for NDA,
  • 36.2 WD for GDA and
  • 22.3 WD for MAV applications respectively.

Source: HSA

31 March 2026
eCTD format officially accepted for regulatory dossier submission

HSA announced that electronic Common Technical Document (eCTD) format will be officially accepted for regulatory dossier submission with effect from 1 April 2026.

  • Companies may submit eCTD packages for actual dossiers through the eCTD portal using SG-HSA eCTD version 1.1, which serves as the official standard for all eCTD submissions.
  • The technical files for defined lists, document matrix and submission type matrix are available online for real-time access and validation, along with an updated sg-regional stylesheet.
  • To support users in navigating the new system effectively, HSA has prepared the necessary resources, including:
    • a training presentation,
    • Q&A document and a
    • portal user manual
  • In addition, HSA has updated the following guidance documents to include eCTD as a dossier submission option.
    • Guidance on Therapeutic Product Registration in Singapore
    • Appendix 2A: Application checklist (ICH CTD_NDA_GDA)
    • Appendix 2B: Application Checklist (ICH CTD – MAV)
    • Appendix 5: Target Processing Timeline
    • Appendix 11: Guideline on Drug Master File
    • Appendix 13: Guideline on MIV Applications for Chemical Therapeutic Products
    • Appendix 14: Guideline on MIV Applications for Biological Therapeutic Products
    • Appendix 17: Guideline on PRISM Submission
  • Companies may continue with their current non-eCTD submission modes but are strongly encouraged to transition to eCTD.
  • HSA will provide advance notice before any subsequent phases of the roll-out.
  • Visit the eCTD webpage to keep up to date with the latest eCTD developments.
Declaration of quality defects to ensure Chemistry, Manufacturing & Controls (CMC) dossier remains valid at the point of submission  

With effect from 1 June 2026 , to promote Good Submission Practice and better support applicants to ensure that the CMC dossier remains valid at the point of submission, applicants will be required to provide an official letter declaring that there are no known quality defects that would require amendment or updates to the submitted CMC package,

  • This enhancement aims to minimise inadvertent submission of superseded technical data and improve regulatory efficiency.
  • Refer to Chapters C, D and E of the Guidance on Therapeutic Product Registration in Singapore for more information.

Source: HSA

China
12 June 2026
China updates drug clinical trial guideline to enhance biotech innovation

China has recently released a new edition of the Good Clinical Practice for Drugs — a guideline designed to ensure the ethical and scientific conduct of clinical studies, aiming to enhance the nation’s research ecosystem and support innovation in biotechnology.

  • The guideline updates the previous version that has been in effect since 2020.
  • The revision comes as the number of clinical trials for innovative drugs in China rises rapidly and the fast-growing global biopharmaceutical industry demands higher clinical trial standards.
  • Key highlights of the guideline include the addition of provisions on data governance, as well as an emphasis on compliance with ethical principles, scientific rules, and relevant laws and regulations when applying new technologies and new methods.
  • Additionally, the guideline clarifies that the principal investigator is the responsible party at the trial site level, and stresses the protection of participants, rigorous review by ethics committees, and the implementation of quality management throughout the entire clinical trial process.

The guideline is set to take effect on 1 September 2026.

Source: NMPA

Japan
22 May 2026
Overview of Orphan Drug Designation

PMDA has launched a new page with the above title, dedicated to orphan drugs.

Source: PMDA

13 May 2026
English translations of notifications and administrative notices related to pediatric drug development,

English translations of several notifications and administrative notices related to paediatric drug development are provided on this page including the partial revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults”

Source: PMDA

AEMPS and Ghana FDA
3 August 2026

AEMPS has carried out a new training activity within the framework of the agreement signed with the EMA to support the regulatory strengthening of countries in sub-Saharan Africa that will be incorporated into the African Medicines Agency (AMA).

  • Following a first visit in April to provide technical assistance on inspections and manufacturing of sterile medicines, a second delegation of experts from AEMPS moved to Ghana for a week in July to carry out a training action on biological drug evaluation at the country’s Food and Drugs Authority (FDA).
  • The sessions addressed the European regulation of medicines, the institutions involved in their evaluation and authorisation, procedures to support clinical development and the accelerated evaluation of promising medicines, and the evaluation of biological and biotechnological medicinal products, including biosimilars and vaccines
  • This collaboration allows AEMPS to act as an ambassador for the European regulatory model, strengthening its international position and its networks of contact with African regulatory bodies.

Source: AEMPS

UK
6 August 2026
Guidance updated: Submitting a clinical investigation proposal for MHRA assessment

This document (Submitting a clinical investigation proposal for MHRA assessment) has been updated to clarify requirements.

Source: MHRA

30 July 2026
Guidance: London Region I MHRA Regulatory Sandbox – call for expressions of interest

Expressions of interest are invited from AI-enabled medical device manufacturers and NHS provider organisations interested in participating in the London Region I MHRA Regulatory Sandbox.

The MHRA is particularly interested in AI-enabled devices that support:

  • preventative and proactive care, especially with a focus on heart health care
  • embedding the neighbourhood health services and community-based care with increased capacity and capability
  • increasing digital access to healthcare services, including through maximising the utility of the NHS App
  • other innovations that could improve patient outcomes and healthcare delivery in London

Source: MHRA

28 July 2026
Guidance: Ambient voice technology-enabled products

This guidance is intended to provide clarity on the qualification and classification of ambient voice technology-enabled products (AVT products) that are medical devices intended to be placed on the market or put into service in Great Britain (GB is England, Wales, and Scotland).

  • This guidance provides illustrative examples that are not intended as exhaustive lists.
  • If in doubt about the device qualification of your AVT product after full consideration of this guidance, or if you have further questions about classification, you may also consider reviewing the MHRA’s guidance on borderline products: classifying medical devices and risk.

23 July 2026
Guidance: Clinical investigations for medical devices

Minor clarifications concerning change to SAE reporting section regarding studies conducted in both Great Britain and Northern Ireland have been applied to this guidance.

Source: MHRA

Guidance: Clinical investigations: compiling a submission

This guidance has been updated to clarify points concerning the following:

  • software standard IEC 62304
  • device labelling
  • essential requirements
  • risk analysis
  • cover letter.

Source: MHRA

20 July 2026
Guidance updated: Register medical devices to place on the market

Clarification has been added to this guidance concerning devices put into service only.

Putting into service refers to the stage at which a device is made available to the final user.

Source: MHRA

14 July 2026
Guidance updated: In vitro diagnostic point-of-care test devices

The guidance has been updated as follows:

  • Outdated references in several sections have been removed.
  • Updated section on training and UKAS accreditation for POCT.
  • Updated section on incident reporting to clarify the scope and reporting routes for medical device incidents in different parts of the UK.

Source: MHRA

6 July 2026
Guidance updated: Clinical investigations for medical devices

Updated information: Applications for an investigative medicinal product and medical device – Parallel Review.

Source: MHRA

11 June 2026
Guidance update: Medical devices – ask for a regulatory advice meeting from the MHRA

Additional information has been added to this guidance on to ‘how to request a regulatory advice meeting’, fees timing update, and updated point of contact.

Source: MHRA

14 May 2026
Guidance updated: Clinical investigations for medical devices

The section Applications for an investigative medicinal product and medical device – IMP+Device of this guidance has been updated.

Source: MHRA

13 May 2026
Guidance updated: Medical devices-conformity assessment and the UKCA mark

This guidance has been updated to add the latest conformity assessment routes flow chart.

Source: MHRA

Team-NB
3 August 2026
Transparency in the framework of the MDR/IVDR proposed revision of the Regulations

You can read the one page document from Team-NB concerning the above topic, here.

Source: Team-NB

8 July 2026
Proposal for risk adaptive surveillance system: IVDR (Complementary-Proposal to EU Commission Proposal COM(2025) 1023 final)

This complementary proposal provides details for the implementation of risk-adaptive surveillance of medical devices and manufacturers by notified bodies considering adaptation to surveillance measures to the risks.

Source: Team NB

Spain
28 July 2026
AEMPS validates a governance model and action plan to facilitate the implementation of the health technology assessment regulation

AEMPS has validated a governance model and an action plan aimed at facilitating the adaptation of the organization to the new functions derived from the implementation of Regulation (EU) 2021/2282 on the Evaluation of Health Technologies (HTAR),

  • This roadmap, within the framework of the EC Technical Support Instrument, aims to implement effectively, coordinated and sustainable the new European framework
  • The governance model defines in a structured way how the AEMPS will organize its processes, resources and capabilities to respond to new regulatory requirements
  • The action plan includes the definition of clear and measurable objectives for each phase of the process, the identification of necessary resources and allocation of responsibilities, the establishment of milestones and monitoring indicators to monitor progress and risk analysis and mitigation measures to ensure project continuity.

Source: AEMPS

4 June 2026
AEMPS promotes a briefing on RECOPS, the new application for the marketing registration of medical devices

On June 17, AEMPS) will hold an online briefing on RECOPS, the new computer application for the registration of marketing of medical devices, other than bespoke products, and in vitro diagnostic medical devices.

  • From 15 June, economic agents who market products in Spanish territory must make the communication to RECOPS within a period of no more than six months from the notification of the product to Eudamed.
  • The objective of the event is to facilitate the transition and present the operation of the RECOPS application.
  • To attend the briefing, prior registration is required, so a registration form has been enabled on the AEMPS website.

Source: AEMPS

27 May 2026
Implementation of RECOPS, the new application for the registration of marketing of medical devices

On 15 June 2026, AEMPS will operationalize RECOPS, the new computer application for the registration of marketing of medical devices, other than customised products, and in vitro diagnostic medical devices.

  • This application will allow you to register and know the products marketed in Spain, along with their instructions and labeling.
  • On May 27, the obligation to perform communications through the old CCPS and RPS applications will end.
  • Both applications will remain available for consultation purposes, but will not allow the realization of new communications from May 28, the date on which the mandatory notification to Eudamed begins.
  • However, the obligation to communicate through RPS will continue to be in force for manufacturers of tailor-made medical devices.
  • From 15 June, economic agents who market products in Spanish territory must make the communication to RECOPS within a period of no more than six months from the notification of the product to Eudamed.
  • To make the communication in RECOPS, the product must be notified and visible in the Eudamed database, since the download of the product data will be made from Eudamed.
  • In order to facilitate the transition and publicize RECOPS, a webinar will be held on 17 June in which the operation of the application will be presented. All information related to this session will be available on the AEMPS website for the next few days.

Source: AEMPS

4 May 2026
AEMPS updates information on the medical device monitoring system and the functions of the health centre monitoring officer

AEMPS has updated the information on the system of surveillance of medical devices and on the functions of the responsible for the surveillance of health centers in Spain published in 2015, in order to adapt it to current regulations.

  • This information is available on the Agency’s website and in PDF format.
  • This document has been updated in collaboration with the Autonomous Communities within the Technical Inspection Committee (CTI).
  • It is a basic and accessible guide that explains the operation of the medical device monitoring system and is intended for health centre monitoring officers to inform and guide them in their duties.
  • The updates include information on the legal framework of the medical device surveillance system, detail what the figure of the person responsible for monitoring them and which centres should designate one is.
  • It also includes information on the procedure for reporting serious incidents involving medical devices, the national alert system and on implant cards and national implant registrations.

Source: AEMPS

Switzerland
1 July 2026
Swissdamed: Mandatory registration applies to medical devices and in vitro diagnostic medical devices As of 1 July 2026

With the introduction of the mandatory registration requirement in swissdamed – the national database for medical devices and in vitro diagnostic devices – a standardised system will replace the existing notification procedures from 1 July 2026.

From 1 July 2026, manufacturers and their authorised representatives must register products, systems and treatment units in the swissdamed UDI Devices module – with a transition period until 31 December 2026. Online registration replaces the previous notification requirement for certain products.

The following will change in practice:

  • Economic operators must register with Swissmedic before placing a product on the market in Switzerland for the first time.
  • The registration requirement applies to all products, systems and treatment units for which sales units are placed on the market in Switzerland after 1 July.
  • In principle, a transitional period applies to these until 31 December 2026.
  • With no transitional period, registration will apply from 1 July 2026 for products that must be reported to Swissmedic due to serious incidents, field safety corrective actions (FSCA) or a trend.
  • For repackaged or unlabelled products, DEVIT products under Article 2a(2) of the Medicines Act (HMG), products manufactured and used in healthcare facilities (so-called ‘in-house products’), and custom-made products, notifications via the form will continue to apply.
  • The previous reporting requirement for Class I medical devices, systems and treatment units, MEP-DEVIT products and in vitro diagnostic medical devices of all risk classes will be replaced by registration in swissdamed.

Source: Swissdamed

19 June 2026
New options for registering devices in swissdamed: Online editor, Machine-to-Machine (M2M) interface, and Master UDI-DI registration

Manufacturers, persons who assemble systems and procedure packs and authorised representatives now have extended functions for registering devices in swissdamed.

  • Thanks to a user-friendly online editor and a M2M interface, the registration process in the UDI Devices module is simpler, faster and better adapted to different user needs.
  • The registration of contact lenses that require a Master UDI-DI is now also supported.

Source: Swissmedic

1 June 2026
Swissmedic webinar how to register medical devices in swissdamed.

On 28 May 2026, Swissmedic held a webinar with the title above. You can view the webinar at this link and the slide deck at this link.

This webinar offers instructions on how to register medical devices in swissdamed:

  • Device registration requirements and timelines
  • Registering a medical device
  • Managing registration updates and changes
  • Linking to a medical device as an importer
  • Accessing instructions and technical information and requesting support
  • Using the swissdamed playground

Source: Swissmedic

Australia
1 July 2026
New UDI requirements for medical devices commencing July 2026

From 1 July 2026, some medical devices supplied in Australia must meet Unique Device Identification (UDI) requirements.

  • The introduction of UDI will begin with higher‑risk medical devices (Class IIb and Class III) followed by lower-risk medical device (Class IIa, Class Is and in vitro diagnostic devices) over later years.
  • UDI can support consumers, health professionals, industry and other stakeholders to more easily access accurate and up‑to‑date information about medical devices.
  • UDI enables improved transparency and traceability across the medical device lifecycle, helping to strengthen safety and performance while supporting better information sharing and digital connectivity within the health system.
  • UDI requirements will be progressively rolled out to other medical device classifications over the coming years. Detailed guidance on these requirements is available at: Complying with the Unique Device Identification requirements for medical devices.
  • Implementation timeframes and the specific requirements for manufacturers and sponsors are available at: Complying with the Unique Device Identification timeframes for medical devices.
  • The TGA has also published information outlining how compliance with UDI requirements will be assessed as part of pre‑market approval activities at: UDI and other TGA processes or activities.
  • Information on medical devices that have a UDI will be available through the Australian UDI Database (AusUDID): Australian UDI Database – external site.
  • Consumers can also access practical guidance on what UDI is and how to search the database at: Unique Device Identification for consumers.

The launch of UDI marks a significant milestone in Australia’s medical device regulatory framework, reinforcing patient safety through improved visibility, traceability and trust in medical devices.

Source: TGA

4 May 2026
TGA information on AUSUDID

The TGA has published the following pages on information about the AUSUDID

Source: TGA

European Commission
28 May 2026

EUDAMED, the European Database on Medical Devices is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. 

As of 28 May 2026, the following 4 modules of EUDAMED became mandatory to use:

  • Actor registration
  • UDI/Device registration
  • Notified Bodies & Certificates
  • Market Surveillance

Source: European Commission

Belgium
28 May 2026
EUDAMED: clarifications regarding obligations from 28 May 2026

From 28 May 2026, the use of the first modules of EUDAMED, the European database on medical devices has become mandatory.

The modules concerned are:

  • Actors: for the registration of economic operators. 
  • UDI/Devices: for the registration of devices, with the exception of custom-made devices. 
  • Notified Bodies and Certificates: for the registration of certificates.

The “Vigilance” and “Clinical Investigations and Performance Studies” modules will become applicable at a later stage. Further information is available on this page.

Source: FAHMP


Australia
31 July 2026
Consultation: Adoption of International Scientific Guidelines in Australia R01-2026

The TGA is seeking feedback on whether 11 international scientific guidelines should be adopted.

Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external consultation to ensure the international scientific guideline is consistent with prevailing requirements in Australia.

The TGA has approximately 370 current adopted international scientific guidelines.

You can respond to the consultation here.

Consultation start date: 31 July 2026

Consultation end date: 11 September 2026

9 July 2026
Consultation: Seeking feedback on improvements to the Therapeutic Goods Advertising Code

The TGA is seeking feedback on options and proposed changes to improve the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code).

The Code sets the standards for advertising therapeutic goods to the public. It helps ensure advertisements:

  • promote the safe and proper use of therapeutic goods
  • are ethical
  • do not mislead or deceive consumers
  • are not inconsistent with public health campaigns
  • support informed health care choices.

The TGA is reviewing parts of the Code to make sure it:

  • is clear and easy to apply
  • reflects current advertising practices
  • supports safe and appropriate use of therapeutic goods.

Your feedback will help to decide whether to update the Code, or provide clearer guidance to advertisers. It will also help to understand the impact of proposed changes on stakeholders.

You can view the consultation paper here and submit your comments on the consultation hub.

The consultation paper is presented in 4 parts:

  • Part 1: TGA outlines key issues raised by stakeholders and present options for change. In some cases, we identify a preferred option.
  • Part 2: TGA proposes targeted changes to improve clarity, consistency and usability of the Code.
  • Part 3: TGA outlines minor or technical changes to improve how the Code operates.
  • Part 4: TGA identifies issues that do not require changes to the Code but would benefit from clearer guidance for advertisers.

This consultation focuses on targeted issues where improvements may be needed. It is not a full review of the Code.

After the closing date, the submissions will be reviewed and decisions will be published on the same consultation page.

Consultation start date: 9 July 2026

Consultation end date: 3 September 2026

Source: TGA

European Medicines Agency
30 July 2026
Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases

The reflection paper will develop and outline general principles for when flexibility and deviations from the requirements of ICH M3 (R2)/ICH S6 (R1) could be appropriate in the context of a medicinal product being developed to treat a severely debilitating and life-threatening disease. In light of the existing ICH S9 guideline and associated Q&A (6) on non-clinical evaluation of medicinal products for the treatment of advanced cancer, such medicinal products would be considered out of scope of the proposed reflection paper.

Comments should be provided using this EUSurvey form.

Consultation start date: 30 July 2026

Consultation end date: 30 September 2026

22 July 2026
Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1

The Guideline on similar biological medicinal products (CHMP/437/04 Rev.1) was last revised in 2015. Since then, major progress has been made in the analytical sciences and regulatory field of biosimilars.
This is especially evident from the following two developments:

Therefore, the Guideline should be updated to reflect the changing legal, regulatory and scientific landscape.

Comments should be provided using this EUSurvey form.

Consultation start date: 22 July 2026

Consultation end date: 31 October 2026

Canada
15 July 2026
Consultation on draft guidance on Ministerial Reliance Order for certain human drugs

Health Canada is seeking feedback on draft guidance on the Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities.

  • This draft guidance sets out the regulatory requirements and process for manufacturers seeking deeming under the Order when filing human or veterinary drug submissions.
  • The guidance should be read along with the Order.
  • Also read the notice for the new draft guidance.

The following are the focus of this consultation:

  • industry
  • health care professionals

Send an email to policy_bureau_enquiries@hc-sc.gc.ca with your ideas or comments. In the subject line of the email, use “Comments on Draft guidance on Ministerial reliance order for human drugs.

Consultation start date: 15 July 2026

Consultation end date: 12 September 2026

15 July 2026
Consultation on a proposed pilot approach to prioritise certain generic drug submissions involving domestic manufacturing within the review queue

Through this consultation, Health Canada is seeking feedback on: a targeted, time-limited pilot to prioritize certain generic drug submissions involving domestic manufacturing with the regulatory review queue

The following are the focus of this consultation:

  • Academia
  • Health system partners
  • Health care professionals
  • Interested members of the public
  • Patient Involvement organizations
  • Industry and industry associations

Send an email to hpfb.engagement-mobilisation.dgpsa@hc-sc.gc.ca with your ideas or comments.

Consultation start date: 15 July 2026

Consultation end date: 12 September 2026

Source: Health Canada

Brazil
7 May 2026
Anvisa publishes version 2 of Guide No. 24 for registration and post-registration of medicines for consultation

Version 2 of Guide 24 was published on 4 May 2026 and concerns the organization of the Common Technical Document (CTD) for the registration and post-registration of medicines.

Following implementation version 1 of the guide, opportunities for improvement and flow changes were observed with an impact on the form of a protocol of petitions in the CTD format.

  • Such changes include:
    • the creation of the Active Pharmaceutical Input Dossier Adequacy Letter (CADIFA) flow
    • the amendment to a mandatory electronic protocol of registration petitions
    • post-registration changes
    • the re-evaluation of the need for physical protocol of all petitions related to the CTD.
  • With this, the text of the Guide was revised in order to promote an adjustment to the new flows and facilitate the protocol of petitions in this format.

You can access the draft guide here.

Consultation start date: 4 May 2026

Consultation end date: 4 November 2026.

Source: Anvisa

ICH
4 June 2026
ICH E6(R3) Guideline for Good Clinical Practice, Annex 2 

ICH E6(R3) Annex 2: Guideline for Good Clinical Practice, Annex 2 was Adopted as Final by the Assembly (Step 4 of the ICH harmonisation process).

The ICH E6(R3) Guideline for Good Clinical Practice (GCP), Annex 2 was adopted as Final by the Assembly (Step 4 of the ICH harmonisation process) and has now entered the implementation phase.

Annex 2 of the Guideline includes additional considerations on how GCP principles may be applied across a variety of trial designs and data sources, where applicable. This will include aspects such as decentralised elements, pragmatic elements and real-world data (RWD) sources.

Source: ICH, Swissmedic

Canada
15 May 2026
Post-notice of compliance changes: Overview of Health Canada’s implementation of ICH Q12 and Q14

Implementation of ICH 12

The initial scope of Health Canada’s implementation of ICH Q12 is only Post Approval Change Management Protocols (PACMPs) for products regulated by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD).

  • Established Conditions (ECs) for all products and PACMPs for products not regulated by BRDD will not be applicable to the initial implementation.
  • Associated revisions to the Guidance on Post-Notice of Compliance Changes: Overall Quality Document for Biologic and Schedule C Drugs for Human Use and companion documents have been published.
  • The submission of PACMPs to BRDD will be accepted following a 90 day coming into effect period on August 13, 2026.
  • Subsequent implementation of ICH Q12 by the Pharmaceutical Drugs Directorate (PDD) will follow with an implementation date to be communicated in 2026.

Implementation of ICH 14

The initial scope of Health Canada’s implementation of ICH Q14 will not include ECs, in alignment with the implementation of ICH Q12.

  • The use of ECs for analytical procedures in ICH Q14 is optional.
  • In this framework, sponsors may propose ECs and associated reporting categories to regulatory authorities, subject to approval, but are not required to define ECs under the minimal approach.
  • The implementation of ECs as part of Health Canada’s implementation of ICH Q12 and Q14 will be further communicated to stakeholders in the future.

Source: Heath Canada

4 July 2026
Anthropic launches its own drug discovery programs

Anthropic is launching its own drug development programs for neglected diseases that the traditional pharmaceutical industry considers unprofitable.

  • It plans to research treatments for diseases that traditional pharma and biotech firms consider unprofitable, focusing on early, preclinical-stage drug development.
  • The move aligns with its nonprofit mission and will help it build better AI models and tools for the broader industry through firsthand experience.
  • The announcement came during an event for the company’s new science AI tool “Claude Science”.

Source: the-decoder.com

UK
11 June 2026

MHRA landmark report reveals public views on AI in healthcare

The MHRA has launched two reports describing the findings of an extensive engagement and evidence gathering programme undertaken to inform future rules on how AI can be used safely in healthcare, published today.

  • The Research and Engagement report sets out one of the most comprehensive evidence bases to date on how AI is currently perceived, used and governed across the UK health system.   
  • Also published today are the findings of the recent Call for Evidence which 760 people and institutions added their voice to earlier this year.  
  • The over-arching view of these contributions is a recognition of the potential benefits of AI in healthcare, provided that rules appropriately set standards for safety and efficacy.
  • There is a broad consensus that existing regulatory approaches need to be adapted to meet the rapid pace of change and development of AI technology.
  • These reports will inform the AI Commission’s recommendations, due to be published later this summer, which will help the MHRA and wider health system shape the rules to protect patients, support innovation and ensure that new technologies deliver real-world benefit for people.

Source: MHRA

European Commission
10 June 2026
Commission publishes Code of Practice on marking and labelling AI-generated content

Today, the European Commission published the final Code of Practice on marking and labelling of AI-generated content.

  • The Code is voluntary and sets out practical steps to help providers and deployers of generative artificial intelligence (AI) systems meet the AI Act transparency obligations that will apply from 2 August 2026.
  • From that date, the AI Act will require clear labelling in key cases. 
  • Deepfakes and AI-generated or AI-manipulated text published on matters of public interest must be clearly labelled.
  • Users must also be informed when they are interacting with an interactive AI system, such as a chatbot. These transparency requirements help people recognise when content has been generated or altered by AI, reducing the risk of deception and manipulation.

Source: European Commission

UK MHRA
15 June 2026

The UK MHRA and the US FDA have today announced a new liaison programme, marking a significant step forward in strengthening the regulatory partnership between the UK and the US.

  • The roles aim to enhance day-to-day collaboration, support scientific exchange and enable faster, more coordinated approaches to emerging regulatory challenges and decisions.
  • Building on the long-standing and trusted relationship, the initiative formalises and deepens cooperation between the two agencies across key focus areas including innovative medicines, medical devices, and emerging technologies such as AI.

Source: MHRA