Regulatory Bodies Approve Of Collaborative Success

It seems clear that collaborative efforts between the major regulatory bodies are

set to continue following the completion of two successful pilots between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

The pilot EMA-FDA Good Clinical Practice (GCP) Initiative was launched in September 2009 with the aim of sharing information on inspections and GCP-related documents of common interest and conducting collaborative inspections. The 18 month pilot phase focused on a subset of regulated products, specifically, those regulated by the Center for Drug Evaluation and Research (CDER) at the FDA and by the EMA through the centralised procedure in the European Union (EU).

The joint final report was published in July this year and provides details on how the agencies shared more than 250 documents relating to 54 different medicines. 13 collaborative inspections were conducted which have contributed greatly to each agencys understanding of the others inspection procedures, as well as the identification of potential improvements to these procedures.

The pilot initiative has received a tremendous amount of support and positive publicity and has resulted in improved communications between the agencies and strengthened trust in each others inspectional efforts. The results obtained from the pilot have exceeded expectations and the agencies have resoundingly judged the initiative as a success.

Collaboration between FDA and EMA has also extended to the Australian Therapeutic Good Administration (TGA) through the International API Inspection Pilot Programme which was completed in December last year with the joint final report published in May this year. The purpose of the programme was to establish confidence between participating regulators (EMA, TGA, FDA, France, Germany, Ireland, Italy, United Kingdom as well as EDQM (European Directorate for the Quality of Medicines and Healthcare)) through exchange of information and collaboration on API inspections among the participating authorities.

During the two-year pilot phase, surveillance lists were shared between the collaborators which identified 97 sites they all had in common. Close to 100 inspection reports were exchanged and examined between the participants and 9 collaborative inspections were conducted.

In the short term, collaboration will continue between the three parties with an aim to extend the programme to all EEA Member States rather than the initial limited number. Long term goals of the programme may include extending it to other comparable regulatory authorities and possibly the World Health Organisation.

by: Adrianne Panini

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