Associated Partner Organisations

PIC/S has signed co-operation agreement with the following four organisations: European Medicines Agency (EMA); European Directorate for the Quality of Medicines (EDQM); United Nations International Children’s Emergency Fund (UNICEF) and World Health Organization (WHO). 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. 

EDQM
 

  


European Directorate for the Quality of Medicines & HealthCare

 

7 allée Kastner
CS 30026
FR - 67081 Strasbourg
France


EMA


European Medicines Agency

 

30 Churchill Place 
Canary Wharf
UK - London E14 5EU 
United Kingdom


UNICEF

 Flag of UNICEF


United Nations International Children's Emergency Fund

 

Supply Division
Oceanvej 10-12
DK - 2100 Copenhagen Ø
Denmark


WHO

 


World Health Organization

 

Avenue Appia, 20
CH - 1211 Geneva 27
Switzerland  

 

The co-operation agreements normally cover the following fields: 

  • Training of Inspectors in the field of GMDP
  • Participation at each other’s meeting
  • Exchange of information

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.

European Medicines Agency (EMA)

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.

European Directorate for the Quality of Medicines (EDQM)

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.

United Nations International Children’s Emergency Fund (UNICEF) 

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.

World Health Organization (WHO)

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.