PIC/S has signed co-operation agreement with the following six organisations: European Commission (EC); European Medicines Agency (EMA); European Directorate for the Quality of Medicines (EDQM); United Nations International Children’s Emergency Fund (UNICEF), World Health Organization (WHO); and World Organisation for Animal Health (WOAH). The respective agreements spell out the scope of the agreement as well as rights and obligations of both parties in the fields subject to co-operation.
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EC
|
European Commission |
|
EDQM |
European Directorate for the Quality of Medicines & HealthCare 7 allée Kastner |
EMA |
Domenico Scarlattilaan 6 |
| UNICEF |
United Nations International Children's Emergency Fund Supply Division |
| WHO |
Avenue Appia, 20 |
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WOAH
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World Organisation for Animal Health 12, rue de Prony |
The co-operation agreements normally cover the following fields:
All agreements are legally non-binding and are signed between PIC/S, as an Organisation, and the respective Partner Organisations. The agreements do not apply to relations between PIC/S and the individual Members of the Partner Organisation (and vice versa). All Partner Organisations regularly attend PIC/S Committee meetings.
The European Commission is an Associated Partner Organisation in PIC/S since 2022. Even before joining PIC/S as an Associated Partner Organisation, there were, on some occasions, direct contacts with the European Commission. This is notably the case during the consultation by the EC on GMP-related guidance documents or in the field of GMP training. In 2015, the European Commission financially supported the PIC/S International Training Programme on API. For more information, see “Expert Circle on APIs”.
PIC/S and EMA have a very long history of co-operation, which has been facilitated by the fact that originally many Members of the PIC/S Committee were also attending the meetings of the EMA Ad Hoc GMDP Inspectors Working Party (IWG). In addition, because the GMP Guides of the EU and PIC/S are equivalent, co-operation in the development and harmonisation of GMP requirements has been essential.
The agreement signed with the EMA is the first ever signed by PIC/S with another organisation. It was signed in 2007 and revised in 2010. In addition to training and the exchange of information, it covers also the exchange of audit reports of GMP Inspectorates under the EU Joint Assessment Programme (JAP) and the PIC/S Assessment and Reassessment Programme (JRP).
In 2012, the agreement was revised to include an Annex on the Harmonisation of PIC/S and GMDP IWG Consultation Procedure. This facilitates the process of keeping the PIC/S and the EU GMP Guides equivalent. In 2022, a new Working Arrangement between DG SANTE/EMA and PIC/S for the exchange of non-public information on medicinal products was signed.
PIC/S and EDQM signed a co-operation agreement in 2007. The agreement defines the co-operation between both organisations in two distinct fields: Active Pharmaceutical Ingredients (APIs) and Blood, Tissues and Cells.
Under the Agreement, PIC/S and EDQM exchange their planned inspections, in particular in non-PIC/S countries. EDQM Inspectors also regularly attend PIC/S training events. EDQM actively participates in the works of the PIC/S Expert Circle on APIs and organised a PIC/S Expert Circle meeting in Strasbourg in October 2015. It is the first Partner Organisation to have officially hosted a PIC/S event.
PIC/S and the Supply Division of UNICEF signed a co-operation agreement in 2008. GMDP Inspectors from UNICEF’s Supply Division regularly participate in PIC/S training events and share their inspection planning with PIC/S.
Historically, relations with WHO date back to the very beginning of the PIC Convention, when the first PIC GMP Guide was elaborated on the basis of the WHO GMP Guide. In 1994, PIC granted WHO an observer status. WHO in turn has invited PIC/S to various experts meetings, in particular those of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. A co-operation agreement was signed in 2009 and revised in 2015. GMP Inspectors from WHO’s Prequalification Programme regularly participate in PIC/S training events and share their inspection planning with PIC/S. WHO actively participates in the works of a number of PIC/S Working Groups as well as in the PIC/S Expert Circle on Controlling Cross-Contamination in Shared Facilities for which it organised a virtual PIC/S Expert Circle meeting in December 2021.
PIC/S and WOAH (formerly "OIE") signed an exchange of letters in 2019. The exchange of letters defines co-operation in the area of good manufacturing practices (GMP) standards and good quality for veterinary medicinal products including veterinary vaccines.
