The TGA says that introducing shorter full-scope inspections will allow it to reduce the backlog while maintaining regulatory oversight and reducing business disruption caused by delays to re-inspections.
Australia’s Therapeutic Goods Administration is to begin carrying out shorter good manufacturing practice (GMP) “surveillance inspections” in an effort to tackle the backlog of inspections that built up as a result of the COVID-19 pandemic.
The new risk-based arrangements, which are expected to be in place for up to two years, will apply to inspections...
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.
