Numerous political and legislative procedures will be needed before new rules on the UK-wide approval of new medicines and their marketing in Northern Ireland can be implemented.
The Windsor Framework on amending the Northern Ireland Protocol, which was agreed by the UK government and the EU on 27 February, may be a sign of growing trust between the two sides after years of prickly post-Brexit relations.
But where medicines are concerned, the European Commission is taking no chances, insisting that the government provide “written guarantees” that...
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.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.
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.
