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).

In 2019, an exchange of letters was signed between PIC/S and the ASEAN Pharmaceutical Product Working Group (PPWG) related to co-operation on GMP related matters. A similar exchange of letters with the ASEAN Traditional Medicines Health Supplements Product Working Group (TMHS PWG) is envisioned for the future.

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.

Heads of Medicines Agencies of the European Economic Area (EEA HMA)

Under the framework of a letter of agreement between PIC/S and EU/EEA Heads of Medicines Agencies (HMA), which entered into force on 15 August 2016, PIC/S and HMA co-operate in exchanging information in the context of the EEA Joint Audit Programme (JAP) of GMP Inspectorates and the PIC/S Joint Reassessment Programme (JRP) of PAs, which ensures that both new and current PIC/S PAs meet the same requirements. PIC/S and HMA also recognise that in the EEA context the EEA JAP and the PIC/S JRP are deemed equivalent. Audit schedules are also exchanged between the two parties with a view to avoid any duplication and foster mutual acceptance and recognition of audits as well as maintain equivalent auditing tools and programmes, including joint training of auditors. In 2021, PIC/S and EMA continued to shared audit reports as well as information on upcoming (re)assessments.

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.

PIC/S is an Observer in ICH since 2017. Following a proposal by the ICH Management Committee (MC) for more routine engagement between PIC/S and ICH, a pilot was launched on 1 May 2020 covering co-operation in ICH Q9 (Quality Risk Management) and Q12 (Pharmaceutical Product Lifecycle Management). Training activities relating to ICH Q9 and Q12 are under development by PIC/S thanks to funding by 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).

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. PIC/S regularly exchanges with ICMRA on regulatory collaboration.

As from 2016, this included PIC/S representation in the ICMRA “GMP reliance framework on equivalency” and taking over the ICMRA GMP project to adapt the ICMRA draft Guidance on Inspection Reliance for PIC/S purpose. The aim of this guidance is to maximise inspection resources by relying on other trusted Regulatory Authorities for the GMP compliance of overseas facilities. The PIC/S network provides a strong foundation for this process by ensuring the capability of PAs via the PIC/S accession process and Joint Reassessment Programme. The PIC/S Guidance on Inspection Reliance (PI 048-1) was adopted by the Committee in April 2018 with an entry into force on 1 June 2018.

In 2021, exchanges focused on the interaction between the ICMRA Working Group on distant assessment and the PIC/S Working Group on Distant Assessment with the aim to avoid a duplication of efforts. Since 2022, collaboration has started on the establishment of a Pharmaceutical Quality Knowledge Management System (PQ KMS), which could help to better inform both public and industry stakeholders on ICMRA’s efforts to improve global regulatory harmonisation and alignment.

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 and further contribute to surveys in this field.