Agency revises internal guidance to incorporate statutory requirement for greater scrutiny of drug manufacturing facilities in countries where past experience demonstrates overall quality is low. Revised MAPP also allows for inspection deferral at sites that have superior quality systems.
The Office of Pharmaceutical Quality in the US Food and Drug Administration’s Center for Drug Evaluation and Research has instructed its staff to follow through on a legislative requirement to regard pharmaceutical manufacturing facilities more suspiciously if they are in countries where such facilities generally have relatively poor compliance histories.
The provision is one of several inspection-related measures in Section 3613 of the Food and Drug Omnibus Reform Act, which...
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.
