Brazil’s medicines regulator Anvisa is considering new rules that would define regulatory reliance procedures for inspections and good manufacturing practice certification.
Anvisa, the Brazilian medicines regulator, is developing new regulations that would allow it to rely on evaluations carried out by other regulators in its decision making on inspection processes and good manufacturing practice (GMP) certification.
Anvisa has just closed a consultation on a regulatory proposal for identifying equivalent foreign regulatory authorities whose inspections and certification...
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.
