Europe – Public consultation on revised general chapter 5.1.6. Alternative methods for control of...
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.6. Alternative methods for control of microbiological quality, published in this...
UK – NICE recommends brentuximab vedotin plus AVD for Hodgkin lymphoma
The National Institute for Health and Care Excellence (NICE) has recommended brentuximab vedotin combined with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients...
UK – Alcohol-mediated perivascular renal sympathetic denervation for resistant hypertension
Evidence-based recommendations on alcohol-mediated perivascular renal sympathetic denervation for resistant hypertension. This involves putting alcohol into the wall of a renal artery to destroy...
Europe – Streamlining development and assessment of biosimilar medicines
EMA is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. With over two decades...
Europe – Pharmeuropa 37.2 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 37.2 is...
Europe – Development of a guideline on the quality aspects of mRNA vaccines –...
This guideline addresses the quality aspects of mRNA vaccines. It addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control of mRNA...
Europe – EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5...
Article 3 paragraph 1 of Commission Regulation (EC) No 1234/2008 (Variation Regulation) refers to Annex II where a classification of minor variations, type IA...
Europe – The evolution of biologicals in the European Pharmacopoeia
Biological medicinal products – or biologicals – are a class of pharmaceutical products derived or refined from biological sources including micro-organisms, animal tissue and...
Europe – Joint strategy sets direction of EMA and EU medicines regulatory agencies to...
EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS), following its recent adoption by the HMA...
UK – NICE recommends Pharming’s Joenja as first treatment for ultra-rare immune disease APDS
The small molecule phosphoinositide 3-kinase delta inhibitor, which is now the first ever APDS treatment to be licensed for use in the NHS in...
