Major pharmaceutical industry groups in the US, like their counterparts in the EU, are concerned that the draft ICH Q12 guideline does not align with the established legal framework in certain ICH regions, including the EU, in terms of implementing key concepts such as established conditions and product lifecycle management.
Major pharmaceutical industry groups in the US say that while they support in principle many of the core principles of the draft ICH Q12 guideline on lifecycle management and post-approval changes, they are concerned about its implementation, and about its incompatibility with the established legal framework in certain ICH regions, including the EU.
They complain that not having a global framework for some core concepts of ICH Q12 like established conditions (ECs) and...
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.
