EMA clarifies application of GMP principles to ATMP starting materials The European Medicines Agency (EMA) issued a question-and-answer guidance on 23 April addressing how good manufacturing practices ...
Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and ...
Australia’s Therapeutic Goods Administration (TGA) has cut its backlog of good manufacturing practice (GMP) clearance compliance verification (CV) applications by around 10% since the logjam peaked in ...