Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.
A coalition of pharmaceutical regulatory authorities on 24 June invited proposals from pharmaceutical companies to participate in joint pilot assessments that could help smooth the way for post-approval chemistry, manufacturing and controls changes and hybrid on-site/remote inspections.
The International Coalition of Medicines Regulatory Authorities said it aims to complete three collaborative CMC assessments and three collaborative hybrid...
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.
