Euro Roundup: EU Parliament’s public health committee adopts a view on critical medicines
The European Parliament’s public health committee has voted on changes to the proposed Critical Medicines Act. The move comes after the European Commission proposed legislation in March to strengthen the availability of critical medicines in the European Union.As part of the process of finalizing the proposal, the Parliament’s Committee on Public Health (SANT) voted on amendments to the Commission’s text last week. The amendments will inform the finalization of the Parliament’s position in January.
SANT received pushback when it discussed planned rules for redistributing medicines between Member States in September. The committee voted in favor of a version of the proposal that allows the EU to force redistribution “as a last resort and only after all other measures have been exhausted.” (RELATED: Euro Roundup: European Commission seeks feedback on planned changes to GMP guidelines, Regulatory Focus, 4 September 2025)
The proposal would enable the EU to transfer medicines from national or contingency stockpiles to where they are most needed. Manufacturers or wholesalers will maintain contingency stockpiles to provide a buffer for critical medicines, supporting availability in the event of shortages or supply disruptions.
EFPIA welcomed SANT’s contingency stock proposals, which it said will move the EU toward a more consistent, risk-based approach. The pharma trade group also highlighted greater harmonization across Member States as a positive, predicting that it can reduce fragmentation and improve predictability for suppliers, provided the obligations remain focused on medicines genuinely at risk of shortage.
Yet EFPIA has concerns about other aspects of the proposals. The trade group said SANT’s definition of “medicinal products of common interest” is too broad. EFPIA also warned that the scope and thresholds around the joint/collaborative procurement framework and local-content measures risk undermining the legislation’s “core logic.”
“Preferential procurement based on manufacturing location risks weakening global supply diversification and undermining Europe’s competitiveness as an export-oriented hub for innovative medicines,” EFPIA said. “Poorly calibrated protectionist measures risk creating new vulnerabilities and exposing Europe to retaliation.”
Press Release, EFPIA Notice
EMA seeks feedback on the radiopharmaceutical quality guideline and concept paper
The European Medicines Agency (EMA) has published a draft guideline and concept paper about the quality of radiopharmaceuticals.
The EMA drafted the guideline to provide specific additional information that companies must submit with marketing authorization applications and variations for radiopharmaceuticals based on synthetic chemical substances. The additional details encompass chemical, pharmaceutical, and biological information, reflecting the properties of this specialized type of medicinal product.
The draft guideline applies to ready-for-use radiopharmaceuticals, radiopharmaceutical preparation kits, and radionuclide generators and precursors. The EMA has clarified the materials that applicants should include in the sections of filings related to the active substance and drug product. The agency is seeking feedback on the draft until 30 April 2026.
Days after sharing its draft guideline, EMA began a consultation on a radiopharmaceutical concept paper. The agency has proposed an update to the radiopharmaceutical annex of its good manufacturing practice guidelines. The planned changes reflect updates to other guidelines and experience gained by inspectors since the annex was published in 2008.
The EMA stated that inspections indicate an update is needed to avoid inconsistent interpretations and to clarify certain parts of the current annex. The agency is accepting feedback on the draft concept paper until 15 February 2026. The comments will inform a draft revised annex, planned for release in September 2027.
Draft Guideline, Concept Paper
MHRA shares roadmap for accelerating access to innovative diagnostics in the UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a roadmap for updates to the regulation of in vitro diagnostics (IVDs).
MHRA is committed to publishing an IVD roadmap as part of its medtech regulatory reforms. The resulting roadmap reflects the UK's commitment to expanding diagnostics into community settings and accelerating access to innovative diagnostics, as outlined in its health and life science plans.
The roadmap sets out broad timelines and deliverables for the next two years. MHRA has split the plan up into three themes: regulatory support for innovative IVD technologies, regulatory science and research, and pandemic preparedness and resilience. Within each theme, MHRA has listed steps it aims to take by the end of 2027.
MHRA Roadmap
Other news
EMA has adopted an updated guideline on stability testing for applications for variations to a marketing authorization. The agency has deleted a section on herbal medicinal products and tweaked information throughout the guideline. The document, which will take effect on 15 January 2026, replaces a text that the EMA adopted in 2014. EMA Guideline
EMA has updated its questions and answers on postapproval change management protocols. EMA Q&A
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.