Current issue of “RMS NEWS” New
- RECENT COMMITTEE NEWS
Public consultation on QRD template version 11. Public consultation on version 11 of the QRD template and the possible inclusion of a ‘key information section’ in the package leaflet of centrally authorised medicinal products is currently open. The CMDh would like to encourage stakeholders to submit comments as the QRD template for MR/DC procedures is based on the QRD template for centrally authorised medicinal products. The public consultation documents and the instructions for submitting comments are available on the EMA website.
Removal of the rabbit pyrogen test. In the context of Directive 2010/63/EU, the EMA has published a guidance document on the phasing out of the rabbit pyrogen test. This follows the revision of the European Pharmacopoeia, which includes the introduction of a new general chapter 5.1.13 Pyrogenicity and the deletion of references to the rabbit pyrogen test from 57 existing monographs. The new and revised texts will be published in Supplement 11.8 of the Pharmacopoeia and will apply from July 1, 2025. As a result, the use of the rabbit pyrogen test will no longer be required in any text of the European Pharmacopoeia and it will be the responsibility of the manufacturers of medicinal products to select an appropriate in vitro test to control the pyrogenicity of their product.
Applicants/Marketing Authorisation Holders are therefore advised to remove the rabbit pyrogen test from their dossiers and to assess the need for a suitable replacement method (see Q&A European Pharmacopeia (Ph. Eur.) - Phasing out Rabbit Pyrogen Test); this applies to both centrally and nationally authorised medicinal products for human use.
Guidance on the application of the new Variation Regulation. Following the revision of the Variation Regulation, which has been in force since 1 January 2025, the European Commission has now published a draft guidance on the details of the different categories of variations and how the procedures work and is expected to be applicable from 15 January 2026.
Updated guidance on the application and impact on the submission of variations should be published soon. Stakeholders are invited to follow the EMA and CMDh websites in this regard and take the necessary steps to prepare their systems, processes, procedures and documentation to comply with the revised variation framework.
Recommendation of the MWP on the requirements for well-established use applications. The CMDh has agreed to the CHMP Methodology Working Party (MWP) recommendation on bridging requirements for applications under Article 10a of Directive 2001/83/EC (‘well-established use’/WEU). The MWP recommendation includes a Q&A document that further clarifies the requirements for bridging data in the context of WEU applications, i.e. when an active substance of a medicinal product has been used in the Union for at least ten years with recognised efficacy and an acceptable level of safety. The Q&A document will be published on the EMA website and on the CMDh website under ‘Procedural Guidance > Application for MA’.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
