Europe – European Commission proposes framework for joint clinical assessments
The European Commission has proposed a framework for joint clinical assessments (JCA) as part of its effort to implement the EU health technology assessment...
UK – UK’s MHRA approves first drug under international recognition procedure
The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen’s bone cancer drug Xgeva (denosumab), the first drug submitted through the international...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024
EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of...
Europe – DARWIN EU® continues expanding its capacity to deliver real-world data studies
The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to...
Switzerland – Nouvelles autorisations de médicaments complémentaires et de phytomédicaments
Chaque année, un grand nombre de médicaments complémentaires et de phytomédicaments ainsi que de bonbons et pastilles pour la gorge et contre la toux...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.
The committee adopted positive opinions...
UK – Pfizer’s Litfulo recommended by NICE as first treatment for severe alopecia areata
NICE’s decision, which could benefit up to 14,000 patients, makes Litfulo the first treatment for severe alopecia areata to be recommended by the agency...
Europe – EMA proposes new guideline on non-inferiority trials
The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new...
Switzerland – Swiss Medtech soutient les négociations concernant un paquet d’accords bilatéraux lll
Pour l'industrie suisse des technologies médicales, la sécurité juridique est primordiale dans les relations avec l’UE. Swiss Medtech soutient donc le Conseil fédéral dans...
Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...
