FDA, TGA and EDQM Collaborate - Confidentiality Agreements, Smart GMP

Confidentiality Agreements

The US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and the European Directorate for the Quality of Medicines and Health Care (EDQM) have established bilateral confidentiality agreements to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers.

The EDQM announced on 29 May 2009 that "these agreements will facilitate the participation of the three organisations in a pilot project involving European regulators, the US-FDA and TGA aimed at rationalising international good manufacturing practices (GMP) inspections. The scope of the agreements includes exchange of information relating to active pharmaceutical ingredients and excipients used in the manufacture of medicinal products. Non-public information shared between the organisations is provided on a confidential basis and all parties have undertaken to protect any non-public information received."

Smart GMP – November 2008

The TGA has joined the FDA and the European Medicines Agency (EMEA) in a pilot project designed to facilitate collaboration of inspections of active pharmaceutical ingredient (API) manufacturers in third countries. If successful, the program could be expanded to include other types of manufacturing facilities.
The collaboration aims to enable participating agencies to leverage limited resources and cast a wider net over manufacturing standards in third country locations. This will be achieved through greater pre-audit communication, widening the scope of planned audits, and conducting joint inspections.

The terms of engagement for the project are being finalised and information about inspection schedules is currently being exchanged to coordinate future audits. The pilot will formally commence at the start of November 2008.

The TGA's involvement provides a further opportunity for Australia to forge stronger links with key international regulators and spread the collective regulatory inspection net wider to provide more efficient and effective use of resources.

The TGA is also working in collaboration with regulators in Canada, Singapore, New Zealand and Switzerland to implement a similar initiative (Smart GMP), which covers both API and finished good manufacturing in sites of common interest.

The TGA continues to work with regulators who are members of the Pharmaceutical Inspections Cooperative Scheme (PIC/S) and through the World Health Organization's joint inspection program.