Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.
The pharmaceutical industry should take advantage of the provision for post-approval change management protocols in the International Council on Harmonization’s Q12 guideline to facilitate analytical procedure changes, a member of the guideline’s implementation working group told a 4 February USP meeting.
The protocols can be used to describe a general approach for changes to analytical procedures across multiple products and testing...
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.
