FDA and partners complete successful inspection pilots

Agencies agree to continue collaboration on inspections

The US Food and Drug Administration (FDA)’s two pilot programmes of collaboration on inspections between the FDA and its European (EMA – European Medicines Agency) and Australian (TGA – Therapeutic Goods Administration) partners have concluded successfully, according to two reports published this week.

Under the joint GCP inspection pilot, the FDA and EMA exchanged more than 250 documents relating to 54 different drug products and, with the GCP inspectors of the EU member states, organised 13 collaborative inspections of clinical trials.

The FDA said this lays the foundation for a more efficient use of limited resources, improved inspectional coverage, and better understanding of each agency’s inspection procedures.

It also demonstrates how the agencies can work together to improve human subject protection and better ensure the integrity of data submitted as the basis for drug approvals.

The report on the joint active pharmaceutical ingredients pilot programme details the success of information-sharing between the FDA, EMA and the TGA, as well as France, Germany, Ireland, Italy, the UK and European Directorate for the Quality of Medicines & Healthcare (EDQM).

Over the course of the two-year pilot, the participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine collaborative inspections.

The FDA used these reports to inform decisions, such as whether to postpone or expedite its own inspection.

The FDA also prohibited imports into the US of a firm’s products based on the negative findings from a European inspection.

‘It is imperative that the FDA works closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone,’ said Deborah Autor, FDA deputy commissioner for Global Regulatory Operations and Policy.

‘We are grateful to our European and Australian colleagues for their willingness to partner with us in these pilot programmes. The pilots are important stepping stones toward further global regulatory collaboration.’