PIC/S offers a variety of advantages to its Participating Authorities. Some of the main benefits for Medicines Regulatory Authorities resulting from PIC/S Membership are detailed below. PIC/S Membership also involves indirect benefits to industry, when their relevant Medicines Regulatory Authority becomes a Member of PIC/S.
Training and networking opportunities within PIC/S
Main benefits for Members
- Training opportunities: PIC/S provides a forum for the training of GMP inspectors thus allowing the latter to benefit from increased training opportunities by attending PIC/S Seminars and Expert Circles and by participating in the PIC/S Joint Visits Programme. In this respect, PIC/S is unique as there is no other international training forum run jointly by Regulatory Authorities (individually, Regulatory Authorities or organisations such as WHO or the EMA provide basic training courses, mainly to new Inspectors).
- International GMP harmonisation: By taking part in the meetings of the PIC/S Committee, PIC/S Participating Authorities are involved in the development and harmonisation of international GMP guides and guidelines. The PIC/S Committee also actively promotes the uniform interpretation of GMP and Quality Systems for GMP Inspectorates.
- Networking: By attending PIC/S activities, participants benefit from personal contacts with other agencies, whether they are part of PIC/S or not. This networking often simplifies contacts and the exchange of GMP related information. In addition, PIC/S is one of the few international GMP fora for networking and confidence building amongst Regulatory Inspectors where experts (GMP Inspectors, specialist GMP Inspectors and Chief Inspectors) can meet, discuss issues of mutual concern and share experiences and information. In other fora, participation is either at the level of Heads of Agencies (e.g. WHO) or at the level of experts in a particular field (ICH).
- High standards: PIC/S ensures that all Members comply with PIC/S standards at all times (assessment of new applicants and reassessment of existing Member Inspectorates). Preparing for the accession to the Scheme (or reassessment) forces improvements in the GMP inspection system and procedures. This results in increased efficiency of the GMP Inspectorate. This is particularly true for Quality System requirements, where PIC/S standards are high, and for GMP training, which is essential in PIC/S.
- Sharing of information: PIC/S allows for a more effective use of inspection resources through the voluntary sharing of GMP inspections reports. Membership is also a cost-saving measure for the inspection authorities confronted with an increase of inspections, notably in the field of Active Pharmaceutical Ingredients (APIs).
- Rapid Alert System: Through PIC/S Membership, Regulatory Authorities automatically benefit from being part of the PIC/S Rapid Alert and Recall System arising from quality defects of batches of medicinal products, which have been distributed on the market. The PIC/S Alert and Recall System is part of a wider system, which includes the Alert and Recall System of EU/EEA/MRA partners.
- Facilitating the conclusion of other Agreements: Membership in PIC/S may also facilitate the conclusion of other agreements, e.g. Mutual Recognition Agreements, between Members at various levels (e.g. Australia-Canada MRA, EU-Switzerland MRA, etc.). During the recently concluded initial negotiation on ASEAN MRA on GMP Inspection, PIC/S Membership accession was accepted as one of the essential criteria for MRA.
Indirect Benefits for Industry
There are also indirect benefits to industry when their relevant Regulatory Authority becomes a Member of PIC/S. These benefits may include the following:
- Reduced duplication of inspections
- Cost savings
- Export facilitation
- Enhanced market access
Although PIC/S is not a trade agreement, Membership in PIC/S may facilitate the export of pharmaceuticals. Some non-PIC/S Authorities accept GMP Certificates from PIC/S Participating Authorities. This means that non-PIC/S Authorities and organisations have a greater confidence in medicines manufactured in countries where the Regulatory Authority is a PIC/S Participating Authority. Consequently, the pharmaceutical industry located in these countries indirectly benefits from PIC/S Membership.