Australia’s TGA joins EDQM's CEP assessment process

The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).

Last month, Australia was accepted as an assessor in the EDQM's procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEPs). The certification procedure for CEPs assesses the suitability of monographs to control the chemical purity, microbiological quality and transmissible spongiform encephalopathy (TSE) risk (if relevant) for any substance covered by a European Pharmacopoeia monograph.

TGA assessors will take part in the scientific assessment of applications submitted by manufacturers to obtain a CEP. This will allow Australia to share information, skills and experience with international colleagues leading to more informed and consistent regulatory decisions internationally.