TGA joins EDQM's CEP assessment process

European Directorate for the Quality of Medicines and HealthCare

17 June 2014

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

In May 2014 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 our international colleagues leading to more informed and consistent regulatory decisions internationally.

Australia is one of a handful of countries outside of European member states that recognises CEPs in its evaluation processes for generic medicines. Working together with regulators from different jurisdictions to develop common standards, guidelines and regulatory requirements will reduce the time to market for therapeutic products ensuring Australians have access to quality medicines in a timely manner.