Accession procedure
If you are interested in becoming a PIC/S Member, you must first complete the Questionnaire and Audit Checklist, which can be requested from the PIC/S Secretariat, together with a cover letter. This is a first but very important step, as it signals your official interest to become a PIC/S Member.
The accession process described in the Accession Guidelines is split into two distinct phases, which are: “Pre-Accession Procedure” and “Accession Procedure”.
The accession process as such is a time-consuming exercise. This is due to the fact that it will take you some time to complete your application and provide all the necessary translations of the supporting documents. In addition, your Inspectorate 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 the national industry to comply with the PIC/S GMP Guide. Finally, the PIC/S Committee, which will deal with your application, meets only twice a year. Please note that the maximum deadline to successfully complete the accession process is six years.
The pre-accession process should be followed if your Inspectorate (i) does not apply the PIC/S GMP Guide; and/or (ii) has not regularly participated in PIC/S training activities; and/or (iii) is unsure whether it meets PIC/S requirements; and/or (iv) has not yet introduced a QS similar along the lines of the PIC/S recommendation (PI 002); and/or (v) has requested to go through the pre-accession procedure.
The advantage of the pre-accession procedure consists in the carrying out of a pre-assessment by an auditor which includes a gap analysis further to which a recommendation regarding the readiness of your Inspectorate to apply for membership is given. The PIC/S Committee then decides on whether e.g. to (i) invite your Authority to apply for membership; (ii) to first comply with PIC/S requirements before applying; (iii) to conclude a partnership agreement. Please note that the maximum timeframe for the pre-accession process is 2 years upon receipt of the completed Audit Checklist and Questionnaire.
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.
Financial costs
The annual membership fee is currently 8,100 CHF (Swiss Francs). It is paid by full Members. Please note that PIC/S membership implies slightly higher costs, as regular participation in the PIC/S Committee meetings (2 per year), seminars (1 per year), expert circle meetings (3 per year) and joint visits (2 to 3 per year) 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), which will be charged once all the complete application has been submitted to the PIC/S Secretariat. In addition, during the whole assessment process, Applicants will have to pay an annual fee corresponding to 50% of the annual membership fee paid by Members. Fees for the pre-accession process correspond to the covering of the expenses of the PIC/S expert involved in the pre-accession process.
Attendance of meetings, seminars & expert circles
Against payment of the fee, non-PIC/S Agencies, which have applied for accession, can attend PIC/S Committee meetings. They can also attend PIC/S seminars and expert circle meetings. You are encouraged to participate in these activities, as it will allow you to get familiar with the PIC/S family. You have also the possibility to contact other PIC/S Members directly. You can for example visit them in order to exchange information on their GMP system and their way of carrying out inspections.
PIC/S Applicants currently being assessed for membership:
Brazil / ANVISA
Iran / MoH
Japan / PMDA, MHLW and Prefectures
South Korea / KFDA
Philippines / PFDA
United Kingdom / VMD (Vet)
PIC/S Pre-applicants currently being assessed for pre-accession:
Armenia / SCDMTE
Belarus / MoH
Uganda / NDA
