France – HAS : Covid-19 – un avis global sur les vaccins bivalents mi-septembre
L’Agence européenne des médicaments (EMA) vient de modifier les autorisations de mise sur le marché (AMM) accordées aux vaccins à ARN messager développés par...
UK – Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark...
For the first time ever in the UK, postmenopausal women will be able to access a low dose Hormone Replacement Therapy (HRT) product from...
France – Accès précoce et compassionnel: les deux nouveaux référentiels de la Cnil attendus...
PARIS (TICpharma) - La Commission nationale de l'informatique et des libertés (Cnil) a reporté à septembre l'adoption définitive de deux nouveaux référentiels relatifs aux...
International – International regulators and WHO: support healthcare professionals to enhance public confidence in...
EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). The statement is aimed...
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,...
