International Co-operation

PIC/S has been a pioneer organisation in the field of pharmaceutical inspections and Good Manufacturing Practice (GMP). It has successfully adapted to a constantly changing environment, in particular globalisation. It is the only organisation worldwide which exclusively deals with GMP. PIC/S' mandate will as from 2023 be expanded to GxP with primary focus on GMDP in the field of training and standards, in line with PIC/S new mission to strive to improve public health by leading development and implementation of inspection frameworks for human and veterinary medicines through harmonisation of standards and offering world class training to regulatory inspectors around the globe.

This is achieved by harmonising inspection procedures worldwide, by developing common standards in the field of GMP, by providing training opportunities to inspectors and by facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing confidence, inspection reliance and avoiding duplication of efforts as well as wasting of resources.

PIC/S is, however, not alone to handle GMP. There are other organisations, which are also involved in this field, although - unlike PIC/S - the GMP part of their activities may only represent a fraction of their total activities.

PIC/S has relations with the following organisations (in alphabetical order):

ASEAN  Association of South East Asian Nations 
EC European Commission 
ECA European Compliance Academy
EDQM European Directorate for the Quality of Medicines
EMA European Medicines Agency
EEA HMA Heads of Medicines Agencies of the European Economic Area
ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICMRA International Coalition of Medicines Regulatory Authorities
IFPMA International Federation of Pharmaceutical Manufacturers Associations
ISPE International Society for Pharmaceutical Engineering
PDA Parenteral Drug Association
UNICEF United Nations International Children’s Emergency Fund
WHO World Health Organization
WOAH World Organisation for Animal Health


While relations with the European Union are of a privileged nature, due to the fact that many PIC/S Participating Authorities are also Competent Authorities of EU Member States, PIC/S aims at remaining impartial and avoiding to give more importance to one organisation over another. All organisations are treated equally.

Co-operation between PIC/S and other organisations are based on the principle of complementarity. Where PIC/S Participating Authorities are already actively co-operating, PIC/S as an organisation strives to not duplicate Members’ efforts. As human and financial resources are getting scarce at the level of national authorities as well as at the level of international organisations, the duplication of tasks with other organisations must be avoided at all costs.

PIC/S is thus increasingly focusing on its added-value and specificity. At the same time, in a world, which has become increasingly globalised, PIC/S aims at turning into a more global and efficient organisation and harmonise international efforts in the field of GMP. This is what PIC/S aims to achieve through its international co-operation efforts.    

Associated Partner Organisations

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);
  • World Organisation for Animal Health (WOAH).

Other Organisations

Without having institutionalised its relations, PIC/S co-operates with an increasing number of organisations, which are also active in the field of GMDP....


Professional Organisations & Industry

Since the manufacturer is at the heart of the GMP process, it is essential for PIC/S to maintain good relations with industry and professional organisations, notably those more active in the field of regulation, guidance documents and training.  The support of industry associations and professional organisations to the goals of PIC/S is a prerequisite for the latter’s successful expansion.  As a matter of fact, industry is generally favourable to PIC/S’ expansion: the harmonisation of GMP facilitates trade and also means fewer inspections for manufacturers.  The latter are increasingly worried by the multiplication and duplication of inspections, which means not only more fees but also more staff immobilised and possibly a lower-than-usual production output during these inspections....