CMDh and other EU updates – May 2024

Last updated: 22 May 2024

See updates at the end of the post.

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.

Source: EMA


Report 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 from the above meeting includes (but is 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. 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.

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
DateUpdate(s)
22 May 2024New 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 2024Link 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