ICH given “two thumbs up" for performance-based established conditions concept in draft Q12 guideline. This approach gives industry much needed flexibility in managing post-approval changes as well as requesting fewer changes from regulators.ICH plans to adopt the guideline as a Step 4 document in 2019.
Pharmaceutical industry officials voiced their support for the inclusion of performance-based established conditions in the draft International Council on Harmonization’s Q12 guideline on post-approval changes. This approach gives manufacturers more flexibility in making lifecycle manufacturing changes to approved products without the need to obtain prior approval from regulators.
FDA’s Ashley Boam discussed some of the key elements of the recently released ICH Q12 draft guideline Feb. 13 at...
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.
