There is now only one country left to join the agreement between the EU and the US on recognizing the findings of inspectorates in each other’s jurisdictions.
Germany has now joined the EU-US mutual recognition agreement (MRA) on manufacturing inspections, meaning that the initiative now includes the US and 27 of the 28 EU member states, with only Slovakia still to join.
The MRA was formed by the EU and the US in 2017 to recognize the findings of inspectorates in each...
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.
