International regulatory news in brief

Turkey

4 September

Updated guideline on biosimilar products

The “Guideline on Biosimilar Medicinal Products”, which defines the concept of biosimilar medicinal products and determines the general principles to be applied in the licensing of these products, has been updated and published in line with administrative requirements and scientific developments. You can view Revision 3 of 2 Sept 2024 here.

Source: TITCK

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29 August

Guideline on Scheduling Processes for Licensing Applications for Medicinal Products for Human Use

This guide which determines the procedures and principles regarding the scheduling processes for applications for human medicinal products that are deemed appropriate after a preliminary evaluation as a result of the examination carried out by the Agency among the human medicinal product licensing applications made to the Turkish Medicines and Medical Devices Agency, has been updated and published in line with administrative requirements.

You can view it here.

Source: TITCK

5 August

Uploading of corrected documents once deficiencies have been identified following first evaluation of licence application for Human Medicinal Products

Currently, for deficiencies identified in the first evaluation of the licence applications for Human Medicinal Products by the Preliminary Examination (CTD) Unit, all modules in the corrected application have to be uploaded to the system again from KİOSK.

• From 8 August 2024, this will change so that only the PDF documents with the deficiencies must be uploaded from KİOSK.
• Any PDF documents other than those notified in the deficiency letter must not be uploaded without being specified in the corrected application cover letter.

Source: TITCK

30 July

Updated Guide on the Working Procedures and Principles of the Medicinal Products for Human Use Priority Assessment Board

This guide which determines the procedures and principles concerning prioritization applications made to the Turkish Medicines and Medical Devices Agency and the work of the Medicinal Products for Human Use Priority Assessment Board established within the Agency, has been updated and published. You can view/download the updated guide here.

Source: TITCK

3 July

Updated Guide on Cases Requiring Re-licensing of Licensed Human Medicinal Products

Revision 1 (1 July 2024) of the above guideline which determines the principles and details concerning license transfers, lost license issuance and transition to certified license for licensed human medicinal products for human use licensed in accordance with the “Regulation on the Licensing of Medicinal Products for Human Use” has been published.

You can view/download it via the link below.

Source: TITCK

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Switzerland

1 September

Electronic data sets from pivotal bioequivalence studies

From 1 September 2024, Swissmedic is accepting electronic data sets from pivotal bioequivalence studies for applications for new authorisation of human medicinal products with known active substances without innovation.

• This option is restricted to bioequivalence studies with a two-way, three-way or four-way crossover design.
• Submission of these electronic data sets enables Swissmedic to analyse data effectively and efficiently using the latest state of science and technology.
• Swissmedic does not require any additional data, but only recommends submitting the data in a standardised electronic format.
• Submission is not mandatory and Swissmedic will continue to base its decisions on study reports in PDF format.
• Section 6.5 Data sets relating to studies has accordingly been added to the form New authorisation of human medicinal products and section 6.5.2 Pharmacokinetic bridging has been revised in the guidance document Authorisation of human medicinal product with known active substance.
• Further information on the technical requirements regarding data sets are set out in Annex 9.3 of the guidance document Authorisation of human medicinal product with known active substance.
• The revised specification documents are valid as of 1 September 2024.

Source: Swissmedic

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Mobile technologies – Submission of films as additional information regarding the safety, efficacy and quality of medicinal products

• From 1 September 2024, Swissmedic will be accepting the submission of films as part of the authorisation of QR codes
• The guidance document Mobile technologies stipulates the options for applying QR codes. The QR code can direct to a training/instructional film as additional information. In addition to the film script, the film can now also be uploaded directly via the portal with the application to apply a QR code.
• The document Form Mobile technologies has been revised accordingly. See section 5.2
• The revised specification document is valid with effect from 1 September 2024.
• The technical requirements for transmitting the films are outlined in the linked publication Submission of accompanying documentation for applications for authorisation and variation for human medicinal products.

Source: Swissmedic

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SEND data sets for new authorisation applications for human medicinal products with new active substances

From 1 September 2024, Swissmedic is accepting SEND (Standard for the Exchange of Nonclinical Data) data sets for applications for new authorisation for human medicinal products with new active substances.

• SEND (Standard for the Exchange of Nonclinical Data) is a data format for preclinical studies that enables assessors, among others, to visualise the results of these studies.
• The U.S. Food and Drug Administration (US FDA) requires the submission of SEND data for new authorisations according to their specifications in the Data Standards Catalog dated April 2024.
• From 1 September 2024 data in SEND format can be submitted to Swissmedic for new authorisation applications for human medicinal products with new active substances.
• This will be particularly useful for applications for which the preclinical data has already been produced in SEND format for submission to the US FDA. Swissmedic does not require any additional data.
• Swissmedic will continue to base its decisions primarily on the underlying study reports in PDF format. However, the use of SEND data sets enables effective and efficient analysis of data according to the latest state of science and technology.
• In connection with the new options for submitting electronic data, Section 6.5 Data sets relating to studies has been added to the form New authorisation of human medicinal products and section 5.2.4 Non-clinical documentation (Module 4) has been revised accordingly in the updated guidance document Authorisation of human medicinal product with new active substance.
• Also available is a Form New authorisation of human medicinal products 

Source: Swissmedic

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Combined studies: New forms and a new information sheet for submissions to Swissmedic

A clinical trial of medicinal products/advanced therapy medicinal products may be conducted in parallel with a clinical investigation of medical devices/an interventional performance study of in vitro diagnostics. In this case, requirements for the different types of research apply in full.

New forms and a new information sheet are now available to facilitate submissions to Swissmedic. Further information combined studies is available here.

Source: Swissmedic

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Changes to the guidance document ‘Time limits for authorisation applications’

Following receipt of an application, Swissmedic checks the formal aspects of the application in the “Formal control and technical validation” phase.

• If the documentation for the application is complete and formally correct, the application is formally accepted as valid (“Doc. OK” milestone). If there are formal shortcomings in the application documentation, however, Swissmedic sends a formal objection to the applicant.
• Previously, written notification of achieving the “Doc. OK” milestone was given for applications for human medicinal products if there had been a prior formal objection.
• In future, there will be no correspondence on achievement of the “Doc. OK” milestone.
• Following a formal objection, the period stated in the guidance document Time limits for authorisation applications is available again to Swissmedic to recheck that the documentation is formally complete. After expiry of this time limit, the “Doc. OK” milestone is deemed to have been achieved.
• For applicants using the Swissmedic Portal, completion of the “Doc. OK” milestone will continue to be visible in the Swissmedic Portal.
• The guidance document Time limits for authorisation applications has been amended accordingly and other formal aspects have been revised.
• The new practice and the revised guidance document Time limits for authorisation applications came into effect on 1 September 2024.

Source: Swissmedic

26 August

Responsible Person: requirements (I-SMI.TI.17e)

An updated of technical interpretation 17 ‘Responsible Person: requirements’ has been published.

• For the inspectorates, to whom all technical interpretations are primarily addressed, the technical interpretation applies with immediate effect, as always in such cases.
• Numerous clarifications have been made in the new version.
• In most cases, compliance with the previous technical interpretation also guarantees compliance with the current version. In the few situations in which this is not the case, the licence holder is generally required to adapt immediately.
• Chapter 5.5 requires a good knowledge of the local language for the responsible person.
• Establishment licence holders whose already approved responsible person does not meet these requirements are given a period of 12 months from the date of publication of the updated technical interpretation to make the necessary adjustments, either by appointing a new responsible person with the required language skills or by ensuring that the responsible person acquires the required language skills within this period.

Source: Swissmedic

25 July

Benchmarking study 2023 – International comparison of Swiss registration times

Swissmedic and the Swiss pharmaceutical associations (ASSGP, Intergenerika, Interpharma, scienceindustries, vips) have conducted a benchmarking study (for the 11th time) that analyses the approval times for human medicines in Switzerland and compares them with the approval times of the EMA and the US FDA.

The applications from participating marketing authorization holders included in the study cover 78.9% of the total Swiss market and 83.9% of the market for prescription drugs.

The analysis is based on:

• new applications for new active substances (NA NAS),
• indication extensions (IE) and
• procedures for known active substances (BWS).

The results serve as a factual basis for the ongoing dialogue between Swissmedic and the pharmaceutical industry. They help to identify and implement improvements in the approval processes for human medicines.

Compared to the previous year, the processing times of the Swissmedic approval procedures were as foolws:

Swissmedic Application processing times for NA NAS and IE applications

The study found that:

• NA NAS applications in the standard procedure had increased processing times (+15%); the effect was particularly pronounced in the subgroup of orphan drugs due to a high proportion of text review rounds (+72%).
• No significant changes were observed in the IE applications.
• There were significantly reduced processing times for NA NAS applications in the Orbis A procedure and according to Art. 13 HMG, which were 28% and 24% shorter respectively than in the previous year.

Swissmedic, EMA and FDA approvals

• Compared to the EMA, Swissmedic was 11% slower for NA NAS applications (all procedures) and 19% slower for IE applications (all procedures).
  • The FDA continued to be significantly faster than Swissmedic: processing times were 31% shorter for NA NAS (all procedures) and 48% shorter for IE (all procedures). 

Submission and approvals gap compared to the EMA and the FDA

• The submission gap and the approval gap with the reference authorities EMA and FDA generally increased compared to the previous year.
• Exceptions were NA NAS applications in the standard procedure, which had shorter submission and approval gaps with both the EMA and the FDA compared to the previous year.

Swissmedic processing times for BWS applications

• In the case of BWS, the processing times for BWS without innovation (generics) in the standard procedure are slightly longer than in the EU.
• In cases in which the procedure according to Art. 13 TMG was applied, the processing time could be shortened compared to the standard procedure.

Labelling phase text review times

In the labelling phase, the proportion of applications with text review rounds increased overall from 20% to 28%, most significantly for BWS (from 14% to 25%).

Further trends and findings from the study are summarized in the Executive Summary.

Source: Swissmedic

2 July

Adaptation of the forms for new authorisation of human medicinal products or changes and extensions of authorisation HAM

Both forms below have been updated and can be viewed at the links provided.

• Form for new authorisations for human medicinal products and 
• Form for changes and extensions to authorisations for human medicinal products

Both forms are valid from 1 July 2024.

With reference to the forms:

• Within 60 days of receipt of a complete application for authorisation, for an extension of the indication or for an extension of the authorisation of a medicinal product, Swissmedic publishes various pieces of information on the application.
• The required information on the indication will be published by Swissmedic unchanged as provided by the applicants in either form.
• Swissmedic has determined that the level of detail of this information varies greatly and that the information content is insufficient in some cases.
•  In order to ensure that the public is adequately informed, Chapter 1 Basic information on the form specifies how the indication should be described. In future, applicants will be required to provide either the requested indication wording or a summary with the following information for the indication requested in an application:
  • Specification of the disease (molecular subtype if applicable)
  • Target population
  • Line specification (if applicable)
  • Specification of type of previous therapies (if applicable)
  • Specification whether monotherapy or in combination with other active substances (if applicable)
• If applicants invoke trade secrets when formulating the area of ​​application, the cumulative, case-specific requirements apply (see explanations in the WL SwissPAR ), which Swissmedic checks for legality.
• Additionally, Swissmedic has simplified the consent to the exchange of information with partner authorities in the two forms mentioned (Chapter 7.7 and 6.8 respectively) and deleted Chapter 7.8 and 6.9 respectively, since Covid-19 Ordinance 3 (SR 818.101.24) will expire at the end of June 2024.

Source: Swissmedic

1 July

At a meeting of Swissmedic’s Agency Council on 26 April 2024 following the conclusion of the consultative process involving subject-matter experts and official bodies, it was decided that the following annexes to TPLRO and TPLO should be amended with effect from 1 July 2024:

• 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

17 June

Changes to declaration of goods for the export of medicinal products (including clinical trials) and narcotics made to the Federal Office for Customs and Border Security (FOCBS)

On 17 March 2024, the Federal Office for Customs and Border Security (FOCBS) introduced the new Passar goods traffic system for exports.

• As of 17 March 2024, additional attributes (provided on this page) must be entered when declaring narcotics in the Passar system:
• For medicines, effective 4 November 2024, when declaring goods, the applicant must indicate the restriction/licence requirement in the Passar system and enter the number of the establishment licence as well as the licence holder.
• The procedure applies to the export of ATMPs (such as CAR T cells or other tissue products) that are exported to foreign countries as non-ready-to-use medicinal products, processed there, and subsequently reimported into Switzerland as a finished product. Effective 4 November 2024, for declaration in the Passar system, information must be entered regarding the clinical trial (Restriction code 511 SMC – Medicinal products, clinical trials, UID, licence number).
• During the transition phase until 31 December 2025, export customs declarations can be submitted either in the e-dec or Passar system.
• Passar is scheduled for rollout for imports starting Q3/25 (Roadmap Passar 2.0 (Einfuhr) (admin.ch)) [information in DE, FR and IT only]. Information on the import of medicinal products, narcotics and clinical trials will be published in due course on the Swissmedic website.
• Effective 1 January 2026, only the Passar goods traffic system can be used.
• There will be changes in the declaration process for medicinal products and narcotics for export. In future, additional attributes must be entered into the Passar system for both types of product.

Further information is available at the link below.

Source: Swissmedic

15 June

Simplification of requirements for renewed authorisation of medicinal products

The first authorisation of a medicinal product is usually valid for a period of five years (Art. 16 para. 2 TPA, SR 812.21).

• Five years after first authorisation, the authorisation holder must submit a once-only application for renewal of authorisation.
• If the authorisation holder misses the deadline for submission of the application for renewal of authorisation, there is the option of submitting an application for renewed authorisation in order to still maintain authorisation.
• Swissmedic has simplified the requirements for the application for renewed authorisation.
• It is now sufficient to send a cover letter confirming that the documentation, including all additions approved since, is identical to that of the authorised medicinal product for which the renewed authorisation application is being submitted and complies with the requirements of therapeutic legislation.
• Other documents from Module 1 and scientific documentation (Modules 2–5) are now no longer required.
• The revised Guidance document and updated Directory are valid with effect from 15 June 2024.
• The Guidance document Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) (ZL201_00_001) has been revised accordingly and the Directory Overview of documents to be submitted (ZL000_00_006) has been updated.

Source: Swissmedic

4 June

Swiss Public Assessment Report (SwissPAR) survey

Since the revision of the Therapeutic Products Act in 2019, Swissmedic has published additional information on medicinal products, including the Swiss Public Assessment Report (SwissPAR).

• The SwissPAR summarises Swissmedic’s approval decisions on human medicinal products with new active ingredients. 
• 5 years after the introduction of the SwissPAR, Swissmedic would like to know whether it meets the expectations of readers and where there is potential for improvement.
• The SwissPAR is aimed at a broad readership, your feedback is important to Swissmedic.

Participation is anonymous and takes about 5 minutes. You can participate in the survey here.

Source: Swissmedic

UK

29 August

MHRA consultation on statutory fees – proposals on ongoing cost recovery

The MHRA is seeking views from interested stakeholders on proposals to update its statutory fees to ensure they continue to recover their costs.

Views are sought on the following proposals:  

• Increasing the statutory fees shown in its consultation document to ensure continued cost-recovery until 2027. 
• Amending the existing Medical Device Registration fee to include the costs for medical device post-market work.  
• Creating a new service providing regulatory advice meetings for medical devices.  
• Amending the fee model for three existing services, as well as increasing the fees to ensure continued cost-recovery until 2027, and also to remove 51 fees that are no longer in use.  
• Updating and clarifying the legal definition of a “standard variation” application for homeopathic products. The “standard variation” application statutory fee for homeopathic products will be unchanged.

The implementation date for these proposed changes is April 2025.

You can respond to the consultation via this link.

Consultation start date: 29 August 2024

Consultation end date: 24 October 2024

Source: MHRA

27 August

Updated guidance: Clinical trials for medicines: apply for authorisation in the UK

This guidance has been updated to amend IVD text on clinical trial/investigation webpages. No further specifics have been provided by the MHRA.

Source: MHRA

19 August

Guidance updated: Apply for the early access to medicines scheme (EAMS)

This guidance has been updated with the addition of more EAMS Scientific Opinion submission dates. See link below.

Source: MHRA

13 August

Guidance: Pre-submission Advice & Support

The UK MHRA offers a pre-submission service before applying for medicines Marketing Authorisations.

• This service aims to provide the best support possible for prospective applicants, whichever application route is chosen.
• Pre-submission advice is a service that provides stakeholders with the means to understand how the process of compiling and submitting applications and supporting evidence applies for their product/s. It is distinct from MHRAs Scientific Advice offering.

For International recognition

• Applicants intending to submit via the International Recognition Procedure have the option of requesting pre-submission advice from the MHRA, by downnloading the Pre-submission Advice Form – International Recognition Procedure (IRP) form, completing and and returning it to presubmission@mhra.gov.uk.  
• These requests will be assessed and the MHRA will either direct to the relevant guidance, provide written advice or offer a pre-submission meeting.

For New Active Substances and/or complex applications

• Companies intending to submit Marketing Authorisation Applications for New Active Substances and/or Biological products must request a pre-submission meeting with the relevant teams at-least 3 months prior to the intended application date.
• This can be done by downloading the Pre-submission Advice Form completing and and returning it to presubmission@mhra.gov.uk.
• If there are any questions or queries on the above document/s and process, please direct these to presubmission@mhra.gov.uk.

Source: MHRA

9 July

International Recognition Procedure

The MHRA has posted the following update:

‘Updated International Recognition Procedure and eCTD guidance’ on its website.

No further information has been provided.

Source: MHRA