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...
Europe – Finding clinical trials with the ACT EU Trial Map
In January 2024, the ACT EU Clinical Trials Analytics Workshop introduced a key deliverable: the integration of a map of clinical trials in the EU, with the CTIS...
UK – NICE recommends Gideon Richter’s Ryeqo as first daily pill for endometriosis
NICE has recommended in final draft guidance that the relugolix combination therapy be used on the NHS in England to treat the symptoms of...
UK – Merck KGaA’s Mavenclad tablets recommended by NICE for wider MS use
The health technology assessment agency has recommended in final draft guidance that the short-course oral therapy be used on the NHS as a first-line...
Europe – Commission proposes Critical Medicines Act to bolster the supply of critical medicines...
Today, the Commission has proposed a Regulation to improve the availability of critical medicines in the EU. The proposal aims to protect human health by incentivising supply...
Europe – EMA spells out data access policy for shortage monitoring platform
On Monday, the European Medicines Agency (EMA) issued a new data access policy, elaborating on the differing levels of data access available to different...
UK – Sobi receives NICE recommendation for Altuvoct in severe haemophilia A
Approximately 7,700 people in England are living with the genetic bleeding disorder and males are disproportionately affected.
The condition results from insufficient levels of functioning...
