ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.
The general assembly of the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use on 16 November adopted the ICH Q13 guide on continuous manufacturing at its meeting in Incheon, South Korea, sources said.
In coming months, ICH member authorities will publish final harmonized Q13 guidance. The assembly had endorsed the guideline in June...
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.
