Last updated: 3 February 2025
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Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh
You can view the decisions here.
Source: HMA
Updated eAF 1.27.0.0 Human Variation form
The Human Variation form v1.27.0.0 was updated on the 29 January 2025.
- The change follows the recent update of the new variation regulation; in the Declaration section in the parallel procedures sub-section, the table with the product/procedure details has been removed.
- It is recommended to use this latest form for new submissions.
- Please note that there is no version number change and that the release notes will be updated and published in the relevant section of the eAF page.
Source: eSubmission
Medicines for children 2023 annual report
This isa Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation1 and on the companies that have failed to comply with any of the obligations in this regulation.
You can view/ download the report here.
Source: European Commission
EMA Write PMS API implementation Guide
The “EMA Write PMS API implementation Guide for the PMS Enrichment process” can be found in the ZIP file and is also available on the EMA PMS Webpage.
This FHIR Implementation Guide (IG) ZIP package is a comprehensive resource for developers, implementers, and stakeholders who are working to adopt and implement healthcare standards based on FHIR (Fast Healthcare Interoperability Resources).
The package acts as an all-in-one toolkit to ensure that healthcare data can be exchanged efficiently, accurately, and securely, in full compliance with FHIR standards.
Source: EMA
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
This paper:
- aims at providing a guidance to the EU/EEA regulatory medicines network on when and how to use specific adverse reaction follow-up questionnaires (Specific AR FUQs) in routine pharmacovigilance activities (GVP module V, V.B.6.1.1.).
- provides guidance on Specific AR FUQs developed by the Marketing authorisation holders (MAHs) at the request of National Competent authorities (NCAs) or the European Medicines Agency (EMA) and does not intend to modify the MAHs internal policies for FUQs. It emphasizes the importance of obtaining structured and detailed information on reported suspected adverse reactions that may impact the benefit-risk balance of a product or have implications for public health.
The guidance outlines the requirements for a Specific AR FUQ and recommends that a Specific AR FUQ should be used for safety concerns that may impact the benefit-risk balance of a product. For important identified risks, FUQs should not be generally used, but in some special situations, a Specific AR FUQ may be necessary instead of the standard FUQ for further characterization of the risk.
The guidance comes into effect on 1 February 2025.
Source: EMA
Industry Proposes Phased Rollout of ePI for Patient Safety and Environmental Sustainability
In a significant stride towards further modernizing patient care, regulatory efficiency, and environmental sustainability, Pharmaceutical Industry Associations (AESGP, EFPIA, and Medicines for Europe) have launched a new series of position papers advocating for the implementation of electronic Product Information (ePI) and improvement of the patient leaflet content.
By transitioning to ePI, patients, healthcare professionals (HCPs), and civil society will benefit from the most up-to-date, accessible medicinal information, ensuring safer use of medicinal products.
Read the full inter-association joint position paper on Electronic Product Information here.
Key highlights
These include:
1. ePI Phasing-In, Paper Phasing-Out:
- The gradual phasing in of ePI is proposed to be fully operational within 4 years after entry into force of the revised General Pharma Legislation and will precede the phasing out of paper leaflets.
- This will ensure patients have continuous access to critical medicinal information via secure, harmonized digital platforms.
- Existing ePI platforms such as National Competent Authority and Industry websites and compendia could be used as solutions to initiate the transition before ePI becomes fully available on the EMA/HMA portal.
- Phasing out paper in self-administered products will be more gradual than for HCP-administered products due to individual needs, administrative capabilities and product specific requirements.
2. Improving PIL
- Patient information leaflets would greatly benefit from layout and readability improvements.
- There are several proposals to benefit correct safe use of medicinal products, by delivering clear information to level up health literacy.
3. Patient Safety and Digital Access
- With 90% of EU citizens regularly accessing the internet1, ePI will allow for availability of up-to-date leaflets, interactive elements, personalized content, and more accessible formats such as large print or multimedia.
- However, alternatives for those without internet access will be retained to guarantee inclusivity.
4. Safeguarding Availability in Small Markets
Multi-country packs, which are simplified by the use of ePI, language exemption and harmonised labelling requirements, will improve the availability of medicines across Europe particularly in smaller markets, reducing logistical burdens and fostering greater supply chain agility.
5. Enhancing Regulatory Efficiency
- The ePI platform is designed to streamline regulatory processes, reducing administrative burdens for both pharmaceutical companies and health authorities.
- The centralized EMA portal will serve as a single source of trustworthy information, fostering transparency and regulatory efficiency across the EU.
Source: Medicines for Europe
Updated version of the “EU eCTD v4.0 Controlled Vocabularies” (.xml format)
An updated version of the EU eCTD v4.0 Controlled Vocabularies is now available here. The updated package contains the missing list (territorial authority) and the unused list was removed (dosage form category).
Source: eSubmission
Important note to Product Lifecycle Management Portal PLM Portal users
Due to an identified issue with ingredient data on the PLM Portal, the following medicinal product data will be removed from the Product Lifecycle Management Portal from 13 to 17 January 2025:
- All ingredients and their strengths
- Pharmaceutical products and routes of administration
- Package Items, Package Item Materials, Package Manufactured Items
- ATC codes
This means the above data will be unavailable in Product Management Service Product User Interface and Human Variations electronic Application Form.
- In practice, for PLM Portal web-based eAF users this means that fields containing this information will be empty in the eAFs generated from the PLM Portal during this period.
- The missing data is not expected to impact the users of the eAF for variations for Centrally Authorised Products; and eAFs submitted with empty fields where the data is ‘missing’ due to the data cleansing exercise will not be rejected.
- Users are requested request NOT to report missing data/data issues in the eAF via the EMA Service desk during this period.
- This means that PLM Portal eAF users should be able to continue to use the web-based form during this period unless unexpected issues, that were not found during testing, are found once the data cleansing process starts.
- However, users should note that the interactive pdf eAF is available for use for all variation procedures and applicants may feel more comfortable using the pdf eAF .
From 20 January 2025, the removed data will be re-uploaded in phases:
- All Centrally Authorised Products’ (CAPs) data will be available from 20 January 2025;
- Non-CAPs data will gradually reappear over the following two weeks.
Source: eSubmission
IRIS guide for applicants How to create, submit and manage IRIS applications, for industry and individual applicants
The updated guide Version 3.6 has been published. You can view it here. In this version, there minor updates to sections 11.3, 11.7 and 11.10.
European Shortages Monitoring Platform ESMP pre-launch for MAHs and available training materials
- As of 28 November 2024, the European Shortages Monitoring Platform (ESMP) is officially live for routine shortage reporting by marketing authorisation holders (MAHs).
- MAHs can now submit data to routinely report shortages of centrally authorised medicines (CAPs) to EMA.
- This marks the start of a transition period that will end on 2 February 2025, when the use of the platform becomes mandatory for CAP shortage reporting to EMA.
- National reporting requirements remain applicable.
- The ESMP will enable information exchange for prevention, identification and management of shortages to ensure medicines are available for patients in the EU and EEA
- The full first version of the ESMP will be released by 2 February 2025 and will expand the platform’s functionalities to include supply, demand, and availability reporting during crises and MSSG-led preparedness exercises by MAHs and NCAs.
- Further information, including training materials, user guidance, and ESMP webinar and ESMP training event recordings, are available on EMA’s website to support stakeholders.
- For more details, visit the ESMP webpage and the press release on EMA’s website.
Source: eSubmission