Rwanda’s health minister says the new body will play a key role in promoting cooperation and mutual recognition of regulatory decisions by individual agencies across the continent.
The creation of the African Medicines Agency drew a step nearer after the African Union signed a “host country” agreement with the government of Rwanda, which this week held a two-day conference in the capital Kigali to help speed the process up.
The agreement is “an important step in getting the work of AMA started,” said the Rwandan Food and Drugs Authority.
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.
The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.
