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
The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).
The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close co-operation with the European Commission (EC) and the World Health Organization (WHO). This has been a best-in-class model of international co-operation between EC, EMA, WHO, and PIC/S.
Annex 1 was first published in 1971 based on a PIC/S recommendation to ensure the sterility of medicinal products for the benefits of patients. It has undergone a number of partial revisions since its publication. This is, however, the first full revision aiming at restructuring this Annex, adding clarity to the requirements on the sterile manufacturing of medicinal products and introducing the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes.
PIC/S decided to establish a Working Group on Annex 1 at its Rome meeting on 15-16 May 2014. It was then merged with the EMA IWG Drafting Group with a view to jointly revise Annex 1. WHO also decided to join the revision process with a view to align Annex 1 to the WHO GMP Guide. The joint Working Group included representatives of the Competent Authorities of PIC/S and EEA as well as WHO. The Working Group was first chaired by Andrew Hopkins (UK / MHRA) and then by Abdelaali Sarakha (France / ANSM).
Following two written consultations of Competent Authorities, the revision of Annex 1 was submitted to joint public consultation in December 2017. Over 6,300 comments were received during the 3-month consultation and then reviewed by the Working Group in 2018-19. This resulted into a new draft of the revised Annex 1, which was submitted to a second joint consultation from February to July 2020, during which approximately 2,000 comments were received and then reviewed by the Working Group in 2020-21.
The revised Annex 1 was then submitted to adoption to the EMA IWG on GMDP and the PIC/S Committee on 1 March and 29 April 2022, respectively. It has then been published by the EC on Eudralex and by PIC/S on the PIC/S website.
Geneva, 15 June 2022: Registrations for the 2022 PIC/S Seminar on "Inspecting the Pharmaceutical Quality System (PQS)" which will be hosted by Ireland / HPRA in Dublin from 5-7 October 2022 are now open (for Medicines Regulatory Authorities only). Extended deadline for registration is 14 September 2022.
The Seminar will be preceded by the PIC/S 50th Anniversary Symposium & Celebration Dinner on 4 October 2022 (only upon invitation).
Geneva, 25 March 2022:
PIC/S is a non-binding, informal co-operative arrangement among Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It has the legal status of an Association under the Swiss law. PIC/S presently comprises 54 Members, which includes the State Service of Ukraine on Medicines and Drugs Control (SMDC).
Given the ongoing tragic events in Ukraine, PIC/S wishes to express its sympathy with all those affected by the war, in particular the most vulnerable: the wounded and the sick. More than ever, patients, whether civilian or military, must be granted indiscriminate access to medicines and medical treatment, irrespective of the circumstances.
As any organisation around the world, PIC/S stands by its Members. PIC/S appeals for a peaceful resolution to the crisis to enable all its Members to continue their important work in protecting patient safety, including the inspection of medicinal products. Violence against staff of any PIC/S Member, who are working to ensure the access of patients to medicine, is unacceptable.
Peaceful co-operation among Regulatory Authorities is at the very heart of PIC/S. PIC/S wishes to reaffirm that as a technical, non-political organisation, it is more important than ever to promote co-operation between Regulatory Authorities in the field of public health. PIC/S is not an agreement among States. While waiting for peace to return to Europe, PIC/S will continue to work untiringly to protect patient safety.
Geneva, 1 February 2022: The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include:
PIC/S Annex 13 has been revised based on EC Regulation No. 536/2014 on Clinical Trials, which will replace EU Annex 13. This is in line with the Co-operation Agreement between PIC/S and EMA, which provides that the PIC/S and EU GMP Guides should be harmonised with the aim of keeping GMP standards equivalent, thus facilitating the exchange and use of information concerning the manufacture of medicinal products.
PIC/S Annex 16 is a new annex to the PIC/S GMP Guide. Historically, PIC/S did not adapt EU Annex 16, when it was adopted as part of the EU GMP Guide. Initially, PIC/S considered this annex to be EU-specific and difficult to transpose for PIC/S purposes, in particular since the PIC/S GMP Guide is limited to the manufacture of medicinal products and not to import and distribution. Following a consultation of PIC/S Participating Authorities in 2017, it was agreed to make an attempt to transpose EU Annex 16, considering that a PIC/S adaptation could offer added benefit to better convey expectations associated with product release and further international harmonisation efforts 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. PIC/S also agreed that elements in Annex 16 related to imported medicinal products would be voluntary, dependent on national law.
Both Annexes were successfully approved by the PIC/S Committee by written procedure on 26 January 2022. The drafting / revision process has been successfully driven by the PIC/S Sub-Committee on the Harmonisation of GM(D)P (SCH), led by outgoing SCH Chair Paul Gustafson (Canada / ROEB) and incoming SCH Chair, Ian Jackson (UK / MHRA).
The revised GMP Guide (PE 009-16), with the revised Annex 13 and the new Annex 16, will enter into force on 1 February 2022. This coincides with the entry into force of Regulation No. 536/2014 on Clinical Trials replacing EU Annex 13.
All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annexes 13 & 16 of the PIC/S GMP Guide into their own GMP Guides.
To download the revised GMP Guide (PE 009-16), please consult the page “Publications”.
Geneva, 4 January 2022: A new PIC/S Executive Bureau (EB) took office on 1 January 2022. Due to the pandemic, the election of the Executive Bureau was carried out by written procedure and successfully completed on 13 December 2021. The PIC/S Committee unanimously elected Mr Paul Gustafson (Canada / ROEB) as Chairperson for the period 2022-2023. Mr Gustafson will be assisted by Ms Susan Laska (US FDA), PIC/S Deputy Chairperson. The full Executive Bureau for the period 2022-2023 consists of: