EMEA proposes a pilot programme to rationalise international inspection activities

As part of its collaboration with international medicines regulators on good manufacturing practice (GMP) inspections, the European Medicines Agency (EMEA) has put forward a proposal for a pilot scheme.

The proposal forms part of international efforts to rationalise the use of global GMP inspection resources by simplifying the administrative tasks relating to inspections and by avoiding the unnecessary duplication of inspection work.

It is based on the system currently operating in the EU where the EMEA outlines a yearly plan for centralised inspections and invites all Member States to contribute to this based on their own inspection plans. Each regulator reserves the right to perform a dedicated "own" inspection, should they consider this necessary.

In the pilot scheme each regulator identifies a contact point specifically for inspection planning purposes. Regulators outline their preliminary inspection plans for the next 6-12 months and provide this information to all other regulators involved. Following review of each others" plans, they identify the following:

If they have previously inspected the site

If they plan to inspect the site within the same period

If they have an interest in the site for some other reason (e.g. other products on the market or used in clinical trials in the territory concerned)

No interest

They communicate this information in a completed form to the other regulators involved.

Based on the information received and the common areas of interest identified, the regulatory contact points set up a teleconference to discuss further sites of interest with the following aims:

1) to investigate the possibility that one of the parties would undertake to cover the activity of interest to the other part(ies)

2) to see whether a joint or co-ordinated inspection could be organised

3) to see if it is possible for one of the inspectorates to perform the planned inspection and to provide outcomes to the other interested inspectorates.

It is proposed to restrict the pilot phase to inspections of APIs, as most authorities already take a risk-based approach to these inspections and there are fewer legal complications to taking results of other regulators into account. Collaboration with the inspectorate of the country where the inspection will take place should also be assured.

If the initial information sharing is restricted to certain basic information, it is anticipated that no commercially confidential information will be involved. If an interest is identified between two or more regulators, each party signs a confidentiality undertaking with respect to discussions concerning that site.

The pilot phase is scheduled to last for 12 months, after which the outcomes should be analysed and a recommendation for future action made. Following the outcome of the pilot phase, and on the assumption that it proves to be successful the following further extensions can be considered:

Extension to a wider group of regulators

Extension to additional types of pharmaceuticals

Extension to other types of inspection (e.g GCP, pharmacovigilance)

Communication of information from regional databases

Definition of common risk-based criteria and conventions for "lead" inspectorates