Europe – High-quality data to empower data-driven medicines regulation in the European Union
EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the...
Europe – Ph. Eur. survey for the availability of alternative plasticisers to DEHP in...
Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have...
Europe – EMA recommends approval of Imvanex for the prevention of monkeypox disease
EMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease.
The medicine has been approved in the EU...
UK – European Commission Decision Reliance Procedure (ECDRP) extension
The European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023. From 1 January 2024 a new international recognition framework will be in...
UK – MHRA safety review of medicines containing pseudoephedrine
Pseudoephedrine is used for the symptomatic relief of coughs, colds and allergies. Pseudoephedrine has been used in the UK for decades in millions and...
International – ICH releases draft guideline proposing harmonized bioequivalence testing
The International Council for Harmonisation (ICH) last month released a draft M13A guideline which proposes harmonized bioequivalence (BE) testing of new orally administered immediate-release...
International – ICH adopts Q13 guideline on continuous manufacturing
The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing....
USA – FDA officials offer CMC advice for gene therapies at OTP town hall
Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged...
Europe – European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and...
Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible,...
USA – Accelerated approval trials: Commenters seek details on single-arm considerations
The US Food and Drug Administration (FDA) aimed to address some of the criticisms of its accelerated approval program with new draft guidance that...
