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Deadline postponed for the second targeted consultation on Annex 1
Those who have already submitted their comments are welcome to revise their contribution if they would like to. Only their latest comments will be considered.
The European Commission remain at your disposal in case you would have any further questions at : SANTE-REVISION-OF-ANNEX-1@ec.europa.eu
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Geneva, 20 February 2020:
Period of consultation:
From 20 February 2020 to 20 July 2020.
Objective of the consultation:
Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients.
Since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow. Key changes are:
A first consultation conducted from 20 December 2017 to 20 March 2018 allowed about 140 companies and/or organizations to comment. The joint PIC/S-EMA drafting group (with WHO participation) processed more than 6200 lines of comments.
Due to widespread interest from industry following the first consultation, and because of substantial modifications introduced in several sections, the European Commission (EC), the European Medicines Agency (EMA), WHO and PIC/S have jointly agreed to engage with stakeholders a second targeted consultation on the updated draft guidance (version 12) focused on the sections and/or significantly modified paragraphs that raised most concerns by stakeholders.
The second targeted consultation aims at collecting experience from the sectors on certain manufacturing steps. PIC/S therefore expect to receive contribution from the associations representing the sectors.
Acknowledgment
In order to maintain the global alignment of standards, achieving at the same time assurance for the highest quality, the document will be, in parallel, subject to a second joint targeted consultation by the EC / EMA, WHO and PIC/S.
Joint Consultation Process
In line with the PIC/S-EMA Harmonised Consultation Procedure, comments will be collected by the EC as well as a number of organisations representing relevant stakeholders, which have agreed to receive all the comments of this second consultation from their members, to compile and send the comments to the European Commission. For the list of stakeholders, please refer to the EC website (link provided below), in particular the section on “Targeted Stakeholders”.
To download the consultation document and the template required to submit comments as well as for the process on how to submit comments, please refer to the EC website by clicking “here” - see in particular the section on “How to submit a contribution”.
The consultation document is also published on the PIC/S website under the section Drafts on the page “Publications”
PIC/S has published the following two guidance documents for GDP inspectors: an ‘Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain’ (PI 044-1) and a ‘Questions & Answers (Q&A) document regarding the PIC/S GDP Guide’ (PS/INF 22/2017). These documents have been prepared by the PIC/S Expert Circle on GDP, led by Karen Ford (South Africa / SAHPRA), and will enter into force on 1 February 2023. They are available for downloading on the page “Publications”.
Geneva, 17 November 2022: A dedicated European Medicines Agency (EMA) Drafting Group, in which PIC/S is represented by Ib Alstrup (Denmark / DKMA), who is also the Chair of the PIC/S Working Group on the revision of PI 011 (PIC/S Recommendation on Computerised Systems), has developed a concept paper on the revision of Annex 11 (computerised systems) of the EU-PIC/S GMP Guide.
This concept paper is submitted to a joint PIC/S-EMA public consultation from 16 November 2022 until 16 January 2023 and can be downloaded on the PIC/S website (https://picscheme.org/en/publications?tri=date#zone ) as well as on the EMA website (https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/gmp-gdp-inspectors-working-group#concept-papers,-reflection-papers-and-draft-guidelines-section )
Comments should be sent to ADM-GMDP@ema.europa.eu using the EMA template downloadable via the link provided in the Concept Paper by 16 January 2023.
Geneva, 14 October 2022: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin (Ireland) on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium titled “Thriving at 50 and Striving Forward” aimed at promoting and highlighting PIC/S’ contributions to international collaboration and co-operation while being resolutely turned towards the future.
The symposium was opened by Ireland’s Health Products Regulatory Authority (HPRA) Chief Executive, Ms Lorraine Nolan, who was hosting. The PIC/S Chairperson, Mr Paul Gustafson (Health Canada) presented on PIC/S new strategic plan for 2023-2027 while the PIC/S Deputy Chairperson, Ms Susan Laska (US FDA), outlined the evolution of pharma industry and PIC/S. The keynote speaker, Ms. Emer Cooke, Executive Director of the European Medicines Agency (EMA), addressed how to strive for better international relationships and collaboration. The programme comprised a wide range of presentations and panel discussions on inspection-related topics, which included participation from Heads of Medicines Agencies, Heads of GMDP Inspectorates and official PIC/S representatives.
Close to 200 participants from all continents participated in the event, including most of PIC/S 54 Participating Authorities and 7 (Pre-)Applicant Authorities, PIC/S Associated Partner Organisations (European Commission, EDQM, EMA, UNICEF, WHO and WOAH) as well as a number of non-PIC/S Competent Authorities. The anniversary also provided a unique opportunity to meet and engage with a range of invited stakeholders present for the occasion and to reconnect with the wider PIC/S network. A more detailed press release will follow covering also PIC/S meetings and 2022 Annual Training Seminar, which took place in Dublin back-to-back with the anniversary symposium.
> To the new PIC/S Strategic Plan (2023-2027)
> To the Anniversary Programme
Geneva, 29 September 2022: The PIC/S Committee has granted the status of Associated Partner Organisation to the European Commission’s Directorate-General for Health and Food Safety (DG SANTE).
Recognising that they share a common goal to protect public and animal Health and Safety, PIC/S and DG SANTE have agreed to enter into a working arrangement to co-operate in areas of common interest. The co-operation will notably be on Good Manufacturing and Distribution Practice (GMDP) standards and their implementation processes for medicinal products for human or veterinary use with a view to make best use of available resources and avoid duplication of activities. DG SANTE has very close relations and interactions as part of the EU Regulatory Network with the European Medicines Agency (EMA), which has its own co-operation agreement with PIC/S. Also the Heads of Medicines Agencies of the European Economic Area (HMA) have signed a letter of agreement with PIC/S in 2016. The co-operation between PIC/S and DG SANTE under this new arrangement will be complementary to those co-operations.
This new bilateral co-operation arrangement will lead to opportunities for increased international co-operation and is very much in line with similar agreements that PIC/S has signed with other associated partners such as EMA, EDQM, UNICEF, WOAH and WHO. Along with this new co-operation arrangement, a new trilateral working arrangement on the exchange of non-public information between PIC/S, EC and EMA has also been signed.
An official welcome will be given to DG SANTE at the next PIC/S Committee meeting in Dublin (Ireland) on 3 October 2022.
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.