Association of inspectorates provides most detailed blueprint yet of how to assure pharmaceutical data integrity.
The Pharmaceutical Inspection Cooperation Scheme leavened the final version of its guidance on data integrity, published 1 July, with provisions encouraging the use of software that removes the human element from the flow of data – and the lack of integrity that can go with it.
PIC/S developed the guidance on pharmaceutical manufacturing and distribution data integrity – the most comprehensive yet published – mainly to...
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.
