BENEFITS OF APSO MEMBERSHIP

·             Training opportunities: Pharmaceutical Cooperation/Scheme 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 APSO Joint Visits Programmed. In this respect, APSO is unique as there is no other international training forum run jointly by Regulatory Authorities (individually, Regulatory Authorities or organizations such as WHO or the EMEA provide basic training courses, mainly to new inspectors). .

·             International GMP harmonization: By taking part in the meetings of the APSO Committee, APSO Participating Authorities are involved in the development and harmonization of international GMP guides and guidelines. The APSO Committee also actively promotes the uniform interpretation of GMP and Quality Systems for GMP Inspectorates.

Networking: By attending APSO activities, participants benefit from personal contacts with other agencies, whether they are part of APSO or not. This networking often simplifies contacts and the exchange of GMP related information. In addition, APSO 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 International Conference on Harmonization (ICH).

·             High standards: APSO ensures that all Members comply with APSO 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 APSO standards are high, and for GMP training, which is essential in APSO

· Sharing of information: APSO 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 APSO membership, Regulatory Authorities automatically benefit from being part of the APSO Rapid Alert and Recall System arising from quality defects of batches of medicinal products, which have been distributed on the market. The APSO 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 APSO may also facilitate the conclusion of other agreements, e.g. Mutual Recognition Agreements, between Members at various levels During the recently concluded initial negotiation on GMP Inspection, APSO membership accession was accepted as one of the essential criteria for MRA.

There are also indirect benefits to industry when their relevant regulatory authority becomes a member of APSO. These benefits may include the following:

·             Reduced duplication of inspections

·             Cost savings

·             Export facilitation

·             Enhanced market access

Although APSO is not a trade agreement, membership in APSO may facilitate the export of pharmaceuticals. Some non-PIC/S Authorities in e.g. Colombia and South Africa accept GMP certificates from PIC/S Participating Authorities. Reputable organizations such as the “Global Fund to Fight AIDS, Tuberculosis and Malaria ”consider PIC/S Participating Authorities as “stringent Regulatory Authorities ”meaning that a medicinal product may be pre-qualified by the Global Fund if it has been authorized by a PIC/S Participating Authority. This means that non-PIC/S authorities and organizations 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."