ICH finally proposes a way to resolve the regulatory complexity that has prevented drug makers from establishing and perfecting global approaches to manufacturing their drug products. But with legal concerns persisting in Europe and possibly lurking elsewhere, approval of ICH's draft Q12 guideline could be difficult.
The International Council on Harmonization is forging ahead with public consultation on its Q12 post-approval changes guideline even though the European Commission has not agreed to adopt the guideline in full.
The move ensures a rocky launch for the guideline and introduces uncertainty into the one-year consultation period – twice the...
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.
