Training projects are intended to strengthen the African regulatory environment, boost the capacity of the African Medicines Agency, facilitate regulatory reliance, and increase joint new drug assessments.
More support for regulatory strengthening in Africa has come after the European Medicines Agency published a call to EU countries asking them to help build up national and regional systems in Africa and get the new African Medicines Agency (AMA) off the ground.
The EMA has a total budget of €450,000 ($480,000) available to offer EU regulators grants to train African regulatory personnel...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
