Experience from previous viral outbreaks has allowed the UK agency to move quickly; long-term focus is on hybrid inspection approach.
The UK Medicines and Healthcare products Regulatory Agency is building upon experience from previous viral outbreaks as it rolls out an increasingly ambitious remote inspection program to help maintain the supply of existing medicines and approve new ones despite COVID-19 pandemic travel restrictions.
The MHRA’s program began quickly after the agency suspended routine site inspections on 20 March. Initial training began within a...
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.
