EU and US drug regulators have signed a new confidentiality commitment that allows both parties to exchange full medicine inspection reports with each other. This was not possible before.
Drug regulatory authorities in the EU and the US will be able to exchange full medicine inspection reports with each other under a new confidentiality commitment signed by the two regions. The initiative aims to improve patient safety on both sides of the Atlantic and to allow EU and US regulators to make better use of their inspection resources.
The new confidentiality commitment, involving the European Commission, the European Medicines Agency and the US Food and Drug Administration, will...
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.
