Geneva, 15 June 2021:
Background
EU GMP Annex 16 on Certification by a Qualified Person* and Batch Release entered into force in 2002. At the time, PIC/S did not deem it necessary to transpose this EU-specific annex for PIC/S purposes. Following the revision of EU Annex 16 in 2016, PIC/S re-discussed whether to transpose Annex 16 in order to harmonise internationally requirements regarding product release in line with PIC/S’ mission “to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of Inspectorates in the field of medicinal products”. The PIC/S Sub-Committee on GMDP Harmonisation (SCH), led by Paul Gustafson (Health Canada), was mandated to transpose a PIC/S version of EU GMP Annex 16 in accordance with a memorandum of understanding with the European Medicines Agency (EMA).
* The PIC/S term of “Authorised Person” and the EU term of “Qualified Person” are strictly equivalent.
Public consultation
Following several internal rounds of consultation and extensive discussion between PIC/S Members on draft versions of PIC/S Annex 16, the PIC/S Committee recently agreed to proceed to Step 2 of the PIC/S consultation process. Step 2 of the PIC/S adoption process enables an opportunity for PIC/S Participating Authorities to consult with stakeholders. PIC/S Participating Authorities may take differing approaches to consultation. Some may engage in consultation at later periods through local harmonisation efforts that realize subsequent adaptation of PIC/S GMP into jurisdictional specific GMP guides or requirements.
This consultation will be launched on 15 June 2021 for a period of 3 months. The consultation will focus on national stakeholders of non-EU/EEA Members of PIC/S, considering that EU/EEA Members of PIC/S already apply EU Annex 16.
Where the implementation of PIC/S Annex 16 will affect a jurisdiction, the competent PIC/S Participating Authority will consult pharmaceutical industry associations. This consultation may also be open to the general public and other stakeholders. Comments from stakeholders will be considered carefully while working toward a general objective of ensuring continued harmonisation and equivalence between the EU and PIC/S GMP Guides. Minimal deviations between the guides will help work toward improved global harmonisation.
International professional and industry associations, which are interested to contribute to the PIC/S consultation process, are invited to channel their consolidated comments through one of the PIC/S Participating Authorities, which will launch a public consultation. For further enquiries, please contact info@picscheme.org
Geneva, 12 November 2026:
The PIC/S Committee adopted the revised Pharmaceutical Inspection Co-operation Scheme (PIC/S 1/95 (Rev. 7)) at its meeting on 2 November 2026 in Istanbul, Türkiye. The revised Scheme entered into force on the same date.
The PIC Scheme serves as the legal basis and institutional framework for PIC/S as a non-profit association established under Swiss law. It governs the organisation and functioning of PIC/S and establishes a legally non-binding arrangement for co-operation between its Members. Unlike the Pharmaceutical Inspection Convention of 1970, which is an international treaty providing for mutual recognition of inspections, the PIC Scheme offers a flexible framework for international regulatory co-operation. Established in 1995, PIC/S core mission is to lead the international development, implementation, and maintenance of harmonised GMP standards and quality systems of Inspectorates in the field of medicinal products.
The previous revision of the PIC Scheme was adopted in November 2019. The current revision introduces significant updates to modernise the institutional and governance framework of PIC/S, reflect the evolution of its activities and strengthen its capacity to fulfil its public health mission.
The main changes introduced by Revision 7 include:
The revised PIC Scheme (PIC/S 1/95 (Rev. 7)) is available on the PIC/S website under Publications Link.
Geneva, 28 October 2026
PIC/S has published the Recommendation PI 058-1 - Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022).
This document was prepared by a sub-group of experts from the PIC/S-EMA-WHO Joint Implementation Working Group (A1IWG) bringing together experts from WHO, EMA, and PIC/S Participating Authorities. The A1IWG was established in January 2024 following the entry into force on 25 August 2023 of the revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide”.
The document, formally adopted by PIC/S, EMA and WHO, was presented to selected Stakeholders during a Briefing Meeting (Webinar) hosted by the EMA on 22 October 2026.
PI 058-1 enters into force on 28 October 2026.
To download PI 058-1, please consult the page “Publication”
Geneva, 23 September 2026:
The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include the revised Annex 19 (Reference and Retention Samples).
The revision of PIC/S Annex 19 primarily concerns Section 9, which addresses reference and retention samples for parallel imported, parallel distributed, and parallel traded products. The note clarifying that Section 9 applies only where local legislation covers parallel imported, parallel distributed, or parallel traded products — present in the previous version of the PIC/S GMP Guide (PE 009-17) — has been retained in the current version (PE 009-18).
This update aligns with the Co-operation Agreement between PIC/S and the EMA, which mandates the harmonisation of PIC/S and EU GMP Guides. The aim is to maintain equivalent GMP standards, thereby facilitating the exchange and use of information concerning the manufacture of medicinal products, in line with PIC/S' mission to lead the international development, implementation, and maintenance of harmonised GMP standards and quality systems for inspectorates in the field of medicinal products.
The revised Annex 19 was successfully adopted by the PIC/S Committee by written procedure on 22 September 2026.
The revised GMP Guide (PE 009-18), with the revised Annex 19 will enter into force on 24 September 2026. This coincides with the entry into force of the revised Annex 19 in the EU following the publication by the European Commission of the revised Annex 19 on Eudralex Volume 4 on 23 June 2026.
All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annex 19 of the PIC/S GMP Guide into their own GMP Guides.
To download the revised GMP Guide (PE 009-18), please consult the “Publications” page.
Geneva, 30 July 2026
PIC/S has published the revised PIC/S Recommendations on Qualification and Validation (PI 006-4).
These Recommendations have been revised by a dedicated PIC/S Working Group, successively chaired by Norman Gray (UK / MHRA) and subsequently jointly chaired by Kevin O’Donnell (Ireland / HPRA) and Rebecca Dowd (USA / US FDA). They supersede the PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation (PI 006-3).
PI 006-4 will enter into force on 1 October 2026.
To download the revised Recommendations document, please consult the page “Publications”.
Geneva, 28 July 2026:
Registrations for the 2026 PIC/S Seminar on “Digital Transformation in GMP” which will be hosted by Türkiye / TMMDA from 4-6 November 2026 are now open (for Medicines Regulatory Authorities only). Deadline for registrations is 31 August 2026 (early-bird) and 23 October 2026 (standard).
For more information, please contact the PIC/S Secretariat.