News

July 2021

Adoption and Entry into Force of PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1)

Geneva, 1 July 2021: PIC/S is pleased to announce that following adoption by the Committee on 1 June 2021, the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) will enter into force on 1 July 2021. The document marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. The PIC/S Working Group on Data Integrity acknowledges the support from professional associations across the pharmaceutical industry who contributed to a targeted stakeholder engagement exercise in 2019. The feedback received was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.

The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis. Based on Members’ comments, it was revised by the Working Group on Data Integrity and then subject to a focused stakeholder consultation on specific issues (November 2018 – March 2019). The Working Group incorporated the feedback from stakeholders and submitted the final draft to the PIC/S Committee for adoption.

The Working Group continues its data integrity activities through development of training material for the PIC/S Inspectorates’ Academy (PIA) and other inspection-related resources for inspectors within the network.

To download this guidance (PI 041-1), please consult the page “Publications”.

September 2022

Publication of revised PIC/S Annex 1

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.

June 2022

PIC/S 50th Anniversary & Seminar 2022

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).

March 2022

Statement on the situation in Ukraine

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.

February 2022

Revision of PIC/S GMP Guide (PE 009-16)

Geneva, 1 February 2022: The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include:

  • a revised Annex 13 on the Manufacture of Investigational Medicinal Products; and
  • a new Annex 16 on the Certification by the Authorised Person and Batch Release

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”.

January 2022

New PIC/S Executive Bureau

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:

  • Mr Paul Gustafson (Canada / ROEB), PIC/S Chairperson;
  • Ms Susan Laska (US FDA), PIC/S Deputy Chairperson and Chair of the Sub-Committee on Strategic Development (SCSD).
  • Ms Anne Hayes (Ireland / HPRA), immediate past PIC/S Chairperson;
  • Mr Jacques Morénas (France / ANSM), Chair of the Sub-Committee on Training (SCT);
  • Dr Andreas Krassnigg (Austria / AGES), Chair of the Sub-Committee on Expert Circles (SCEC);
  • Mr Ger Jan van Ringen (Netherlands / IGJ), Chair of the Sub-Committee on Budget, Risk and Audit (SCB);
  • Mr Ian Jackson (UK / MHRA), Chair of the Sub-Committee on GM(D)P Harmonisation (SCH);
  • Dr Kentaro Hara (Japan / PMDA), Chair of the Sub-Committee on Communication (SC COM); and
  • Mr Henning Willads Petersen (Denmark / DKMA), Chair of the Sub-Committee on Compliance (SCC).