Other Organisations

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

Association of South East Asian Nations (ASEAN)

As a number of PIC/S Participating Authorities are also Competent Authorities in the field of GMDP under the Association of South East Asian Nations (ASEAN), PIC/S is regularly meeting representatives of ASEAN Competent Authorities as well as of the ASEAN Secretariat. The third PIC/S-ASEAN Forum took place in the margins of the 2015 Annual Training Seminar in Nusa Dua (Bali, Indonesia) during which PIC/S has proposed to ASEAN to sign a Memorandum of Understanding. In addition to these meetings, one of the ASEAN Participating Authority of PIC/S acts as “Liaison Officer” between PIC/S and ASEAN and regularly reports on the latest meetings of the Pharmaceutical Product Working Group (PPWG) of ASEAN Member States and the Joint Sectoral Committee (JSC) on GMP Inspection of Manufacturers of Medicinal Products (JSC GMP MRA).

PIC/S Membership has been defined as one of the essential criteria for the establishment of a Sectoral MRA by ASEAN in the field of GMP inspections. The scope of the ASEAN MRA is, however, limited to medicinal products in finished dosage forms (Modern Medicines); Active Pharmaceutical Ingredients, Biologicals, Radiopharmaceuticals, Investigational Medicinal Products and Traditional Medicines are excluded. To become an ASEAN listed authority under the ASEAN MRA on GMP, a Competent GMP Authority of ASEAN must either be a PIC/S Participating Authority or lodge an official application with the ASEAN Secretariat to be a “Listed Inspection Service” under the ASEAN Sectoral MRA on GMP Inspection.

European Commission (EC)

PIC/S’ relations in the EU are mainly governed by the MoU with the EMA.  However, on some occasions, PIC/S has also 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”.

Heads of Medicines Agencies of the European Union (HMA)

Programme (JAP), which aims at regularly assessing the competence of EU and EEA Competent Authorities in the field of GMP. To avoid the duplication of efforts, PIC/S has proposed to EU HMA to conclude an MoU on the mutual recognition of audits undertaken under the JAP and under PIC/S, whether as part of the assessment of new PIC/S Participating Authorities or as part of the reassessment of PIC/S Participating Authorities.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) 

Relations with ICH date back to the 1990s. In 1996, PIC/S decided at a conference in Canberra (Australia) to develop a draft Guide on GMP for APIs. In 1998, PIC/S agreed to hand over the draft API Guide to what was called at the time the “International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use” in order to enable industry to become involved in the drafting process. The “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” (ICH Q7A) was finalised in November 2000 after extensive public consultation. Most countries have adopted the ICH document as a GMP requirement for APIs. ICH Q7A has become Part II of the PIC/S GMP Guide.

Between 2010 and 2013, PIC/S developed a document on Questions and Answers (Q&A) relating to the implementation of Part II (ICH Q7) of the PIC/S GMP Guide. In 2013, in order to avoid duplication with a similar initiative undertaken by ICH, PIC/S agreed to hand over its Q&A document to ICH, provided ICH acknowledged the work carried out by PIC/S. PIC/S participated in the subsequent meetings of the ICH Working Group on the Q7 Q&A. The ICH Q7 Q&A has since been published.

Although PIC/S has no official status with ICH (and vice versa), this could change in the future, as PIC/S is considering applying for observer status to ICH.

International Coalition of Medicines Regulatory Authorities (ICMRA)

The International Coalition of Medicines Regulatory Authorities (ICMRA) is an informal coalition of national and regional Medicines Regulatory Authorities (MRAs) of: Australia (TGA), Brazil (ANVISA), Canada (HPFB-HC), China (CFDA), European Union (EMA and EC), France (ANSM), Germany (PEI), Ireland (HPRA), Italy (AIFA), Japan (PMDA and MHLW), Korea (MFDS), Mexico (COFEPRIS), the Netherlands (MEB), New Zealand (Medsafe), Nigeria (NAFDAC), Singapore (HSA), South Africa (MCC), Switzerland (Swissmedic), the United Kingdom (MHRA) and the United States (FDA).

The objective of ICMRA is for Heads of Medicines Agencies to have a common, strategic vision on issues of common interest such as on capacity building, information sharing, generic medicine, etc. GMP equivalence and the better sharing of GMP-related information are essential for ICMRA, which considers PIC/S membership as the main reference. Non-PIC/S Members of ICMRA have been encouraged to join PIC/S.

PIC/S supports the ICMRA’s objectives, in particular the better use and sharing of resources globally. Close co-operation is in the mutual benefit of both organisations, in particular in the field of GMP.

Organisation for Economic Co-operation and Development (OECD)

In 2015, the Organisation for Economic Co-operation and Development (OECD) invited PIC/S to participate in a survey on international regulatory co-operation, in which some PIC/S accomplishments, in particular in the field of training, were highlighted. PIC/S has also been invited to attend OECD meetings on international regulatory co-operation.