Requirements for membership
PIC/S membership is open to GMP inspectorates having an inspection system comparable to that of other PIC/S Members (Article 3 of the PIC Scheme). The main conditions are to have a law on medicinal products, a GMP Guide equivalent to that of PIC/S (or the EU GMP Guide), a GMP inspectorate, which fulfils PIC/S quality system requirements, and experienced GMP inspectors.
The exact requirements can be seen from the Audit Checklist which is applicable to both assessments and reassessments under PIC/S.
Indeed, existing PIC/S Participating Authorities are also reassessed for equivalence on a regular basis. This ensures that both new applicants and older members fulfil the same requirements.
Accession procedure
An Authority interested in becoming a PIC/S Member must first request the application form & questionnaire from the PIC/S Secretariat. This is a first but very important step, as it signals the Authority’s official interest to become a PIC/S Member. The Authority must then return the complete application, including all supporting documents to the PIC/S Secretariat.
The Guidelines for Accession describe how the application will then be processed. The accession process as such is a time-consuming exercise, which normally takes between two and three years. This is due to the fact that it takes some time to complete the application form and questionnaire and to provide all the necessary translations of the supporting documents. In addition, the applicant Authority may have to take measures to fulfil PIC/S requirements (e.g. regarding its quality system, the training of inspectors, etc.) and must allow sufficient time for national industry to comply with the PIC/S GMP Guide.
The maximum deadline to successfully complete the accession process is six years.
“Before a Regulatory Authority is accepted by PIC/S, a detailed assessment is undertaken to determine whether the Authority is able to apply an inspection system comparable to that of current PIC/S Participating Authorities. This assessment involves an examination of the Authority’s GMP inspection and licensing system (or equivalent), quality system, legislative requirements, inspector training, etc. It is followed by a visit by a PIC/S delegation to observe in particular inspectors carrying out routine GMP inspections.” (extract from the PIC/S Blueprint, paragraph 115)
An applicant Authority having been assessed by other PIC/S Participating Authorities (e.g. Australia, Canada) or by the EU (e.g. pre-MRA audit reports) will be invited to share the assessment reports with PIC/S. This will both simplify and accelerate its accession to PIC/S.
Financial costs
The annual membership fee is currently 8,100 CHF (Swiss Francs). It is paid by full Members only. PIC/S membership implies slightly higher costs, as regular participation in the PIC/S Committee meetings (2 per year) and training events (i.e. seminars, Expert Circle meetings and joint visits) is normally expected from Members. All these events take place in other PIC/S countries around the world and last from 1 to 3 days each. A corresponding travelling budget should thus be ensured.
Applicants have to pay a registration fee equivalent to the annual membership fee (i.e. CHF 8,100). This administrative fee will be charged once all the complete application has been submitted to the PIC/S Secretariat.
Another fee covering part of the costs linked to the visit by a PIC/S Delegation may be charged in connection with the on-site assessment of a PIC/S Delegation. Such a visit usually takes place one or two years after the application has been submitted.
Attendance of meetings, seminars & expert circles
Unless invited by the Chair, PIC/S applicant Authorities cannot attend PIC/S Committee meetings. They can, however, attend PIC/S seminars and Expert Circle meetings. They have also the possibility to contact other PIC/S Participating Authorities directly e.g. for visiting them in order to exchange information on their GMP system and their way of carrying out inspections.
South Africa / MCC: an example of successful accession to PIC/S
This article describes the accession process of South Africa’s Medicines Control Council (MCC) to PIC/S. It gives a good overview on the challenges encountered and on the efforts to be developed by a Regulatory Authority to be in line with PIC/S membership requirements.
