UK – Guidance : Full pack dispensing of valproate-containing medicines
This is guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs). These amendments...
Europe – Convergence: EMA official urges transition of existing clinical trials to CTIS portal
Sponsors should plan to transition existing clinical trials into the new Clinical Trial Information System (CTIS) portal by 30 January 2025, Anabela Marcal, of...
Europe – EMA Management Board: highlights of October 2023 meeting
EMA’s Management Board met on 5 October in Amsterdam.
Clinical trials in the EU
The Board adopted revised transparency rules for the publication of information on clinical...
Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
Europe – EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS...
The European Union’s proposed restriction on the use of per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” would have grave implications on...
Europe – Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs...
The European Commission’s plan to reform pharmaceutical legislation could cause three fewer rare disease drugs to come to market each year, according to a...
Switzerland – Swissmedic updates adverse event reporting requirements for 2024
Swissmedic has updated its frequently asked questions (FAQ) page for marketing authorization holders submitting adverse events reports (ADR) as part of the agency’s pharmacovigilance...
UK – Guidance : Drug Safety Update: monthly PDF newsletter
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines...
UK – NICE nod for Darzalex with lenalidomide and dexamethasone
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended Darzalex –...
Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.
In the document, Swissmedic outlines the...
