Last updated: 6 June 2024
See updates at the end of the post.
New Paediatric submissions are mandatory via IRIS platform from 4 June 2024
From 4 June 2024, the following types of new paediatric submissions must be submitted out via IRIS:
- Initial paediatric investigation plan (PIP)
- Modification of an agreed PIP
- Product-specific waiver
- Compliance check
- Annual report on paediatric deferred measures
- Confirmation of applicability of a class waiver, or inclusion of an indication within a condition
- Discontinuation of paediatric development.
To ensure a smooth transition to using the IRIS platform, it is essential that applicants prepare well in advance, including registering for IRIS.
Source: eSubmission
Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)
This Q&A document has been updated. Here, you can view the track changed (Nov 2023) and clean (May 2024) versions of the document. There are substantial changes throughout the document.
- This “questions and answers” document provides regulatory and procedural guidance and should be read in conjunction with the EMA Guideline on quality documentation for medicinal products when used with a medical device.
- This guideline:
- describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part, and submitted in accordance with Directive 2001/83/EC and/or Regulation (EC) 726/2004.
- focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy (and hence overall benefit/risk determination) of a medicinal product.
This document covers guidance for:
- Medical devices that form an integral product with a medicinal product,
- Medicinal products that include a medical device in the secondary packaging of the marketed medicinal product (co-packaged)
- Consultation procedure for ancillary medicinal substances that are integral part of medical devices
- Consultation procedure for companion diagnostics.
The document will guide marketing authorisation holders, applicants and notified bodies through some of the changes introduced by the medical devices and in-vitro diagnostics regulations. It includes the following:
- insights on integral drug-device combinations and their lifecycle management
- labelling requirements for medical devices co-packaged with medicinal products
- information on the consultation procedures for medical devices with ancillary medicinal substances and companion diagnostics
The document has been updated substantially, including the following new Q&As:
- 1.3 How to obtain advice on the qualification/classification of my drug-device combination, especially for borderline products?
- 2.4. Can I provide a notified body opinion concluding on partial compliance with the GSPR? What is the scope of the notified body opinion ?
- 2.7. How should I submit minor changes to the terms of the Marketing Authorisation for integral DDC following changes to the device (or device part)?
- 2.8. Will I need to provide a new/updated notified body opinion for changes related to the medicinal product (e.g. extension of indication, new strength, new pharmaceutical form) in an integral drug-device combination?
- 3.2.1 If co-packaged medical devices class I and class IIa, are supplied without an individual packaging and it is not technically feasible to implement the labelling requirements on the device itself, what alternative solutions could be considered to display the labelling requirements?
Further information is available in this blog post.
Source: EMA
Report and minutes from the CMDh meeting held on 23-25 April 2024
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
The report and minutes from the above meeting include (but are not restricted to) the following items:
1. Questions and Answers on nitrosamines
The CMDh in collaboration with the EMA agreed an update of the joint EMA/CMDh Questions and Answers for MAHs/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products.
- Q&A 10 has been updated to remove the timelines until when Ames assays not complying with the requirements of the EAT protocol are acceptable, as this deadline has passed.
- Appendix 3 has also been updated with a checklist of the information required for the EAT.
- The new Q&As will be published on the EMA website and on the CMDh website under “Nitrosamine impurities”.
A link will be provided here once the updated document is available.
2. Implementation of a supporting checklist into Appendix 3
CMDh was informed about the update of Appendix 3 of the Q&A on nitrosamines with a table containing the information required for the EAT and which can be used as a checklist to provide a summary of the conditions used and results obtained. The updated appendix will be published on the EMA website.
3. Template for request for MRP/RUP
The CMDh agreed an update of the template for request for MRP/RUP.
- The template has been updated to further align it with the updated Questions and Answers on the Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) and to include amendments in line with the experience gained.
- The updated template will be published on the CMDh website under “Templates > MRP/RUP”.
- Here, you can view the track changed and clean (April 2024) versions of the updated template.
4. Submission of parallel national variations instead of worksharing
i. proposed updates to sections 4.2, 4.4 and 4.8 of the SmPC
- The CMDh discussed a request for variation worksharing instead of parallel national variations and agreed that the proposed updates to sections 4.2, 4.4 and 4.8 of the SmPC should be submitted via variation worksharing.
- It was noted that the worksharing should include MAs in all MSs where the product is authorised, even if the variations are already in an advanced stage or have been finalised to ensure a harmonised EU outcome.
ii. proposed updates to sections 4.4. to 4.9 of the SmPC for alignment with the CCDS concerning important safety information
- The CMDh discussed a request for variation worksharing instead of parallel national variations and agreed that that the proposed updates to sections 4.4. to 4.9 of the SmPC for alignment with the CCDS concerning important safety information should be submitted via variation worksharing.
- It was noted that if the present situation in some sections of the SmPCs is different, this does not prevent submission via worksharing, which is still relevant and possible to ensure a harmonised EU outcome.
5. Marketing Authorisation Renewals
The CMDh discussed the experience gained with the use of expanded renewals one year after the revision of the Best Practice Guide for Renewals.
- The CMDh agreed with the current practice, according to which the RMS can decide on the use of expanded renewal (in contrast to any request for additional documentation which is at the discretion of each CMS).
- The CMDh also agreed that there are no other general reasons for requesting an expanded renewal other than what is already stated in the BPG (i.e. concerns regarding the benefit/risk balance of the medicinal product, such as pharmacovigilance issues) and that there is also no need to prepare an internal guidance at this stage.
- It was noted that inclusion in a previous (safety) referral in itself does not warrant an expanded renewal assessment.
6. Legal basis for abridged applications omitting orphan indications
The CMDh discussed generic DCP applications for which some therapeutic indications approved in the SmPC of the centrally authorised RefMP have been omitted since they are still under orphan market exclusivity.
- The CMDh discussed if the applications can be accepted under Article 10(1) or if for formal reasons the change in indications requires a hybrid application according to Article 10(3).
- It was noted that, although the indication in the generic applications is not identical to that of the RefMP, an application in such scenario could be accepted under Article 10(1) of Directive 2001/83/EC.
- Additionally, the CMDh agreed that, in general, the use of the legal basis Article 10(1) with fewer indications than those approved for the RefMP would be acceptable if based on market exclusivity reasons.
AESGP, EFPIA and Medicines for Europe joint recommendations for better patient information leaflets
The European pharmaceutical industry, represented by AESGP, EFPIA, and Medicines for Europe, has joined forces to enhance the content of medicinal product information leaflets, prioritising patients’ needs. These associations have put together key recommendations to improve leaflet content and accessibility, thus advancing health literacy.
Key recommendations for improvement
Drawing on the Nivel report and direct input from patients, caregivers, and user testing companies, AESGP, EFPIA and Medicines for Europe propose the following actionable recommendations:
- Create clear and informative leaflets that not only inform but also engage patients, encouraging correct use of medicines.
- Condense content into shorter, patient-relevant formats, ensuring essential information is easily digestible.
- Tailor information to focus on patient-relevant aspects, using accessible language to minimise text volume and maximise clarity.
- Adopt clearer layouts and structures to improve readability and comprehension.
- Reduce repetitions by addressing elements across different sections of the leaflet, enhancing coherence and flow.
- Incorporate visual alongside text to aid comprehension and engagement.
- Have in future legislation the detailed requirements on the content of the leaflet included in the Annex to the Directive, to facilitate better possibilities to update it.
- Establish readability guidelines to consolidate existing guidance documents for consistency and clarity.
- Implement user testing improvements, e.g. the regulatory authorities Quality Review of Documents (QRD) template’s wording should not be mandatory if simpler, alternative phrasing is clearer to the general public.
Source: AESGP
Updates
| Date | Update(s) |
|---|---|
| 5 Jun 2024 | 1) Heading Report from the CMDh meeting held on 23-25 April 2024 updated to Report and minutes from the CMDh meeting held on 23-25 April 2024. 2) Link added to the minutes from the meeting. 3) New Items 4, 5 and 6 added under the same heading. |
| 30 May 2024 | New section New Paediatric submissions are mandatory via IRIS platform from 4 June 2024 added. |
| 22 May 2024 | New section Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746) added. |
| 15 May 2024 | Link to updated document added under section Report from the CMDh meeting held on 23-25 April 2024, sub-heading 2. Template for request for MRP/RUP |