With the European Medicines Agency's Amsterdam move completed and the US/EU inspections MRA guillotine stayed, lull in EU drug GMP noncompliance notices has ended.
The rate at which EU member authorities issue good manufacturing practice (GMP) noncompliance notices appears to be recovering in the second half of 2019 after falling in the first half as the European Medicines Agency relocated from London to Amsterdam.
The EMA’s 2019 midyear report notes that the agency reduced or suspended a lot of inspection-related activities as it moved to Amsterdam in the
Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.
England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.
The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
