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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(EMA), WHO and PIC/S have jointly agreed to engage with stakeholders a second targeted consultation on the updated draft guidance (version 12) focused on the sections and/or significantly modified paragraphs that raised most concerns by stakeholders.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”
Geneva, 1 June 2020: The following new PIC/S guidance documents have been successfully adopted:
The documents, which have been successfully developed by the PIC/S Expert Circle on Controlling Cross-Contamination in Shared Facilities, led by UK / MHRA, entered into force on 1 June 2020.
To download these documents (PI 052-1 and PI 053-1), please consult the page “Publications” or click on the links below:
Geneva, 19 February 2020: On 17 February 2020, the Saudi Food & Drug Authority (SFDA) applied for PIC/S membership. The Rapporteurs will be appointed by written procedure.
Geneva, 30 December 2019: the PIC/S Committee met on 11-12 November 2019 in Toyama (Japan). The meeting was followed by the PIC/S annual training Seminar on 13-15 November 2019. The topic of the seminar was "Quality Assurance of Sterile Medicinal Products - Annex 1".
The press release regarding these events is available in newsletter format here or can be downloaded in pdf format from the link below:
Geneva, 28 November 2019: PIC/S has published on a draft basis a Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management (PI 054-1 (Draft 1)) developed by the PIC/S Expert Circle on Quality Risk Management (QRM).
This draft Recommendation will be applied on a 6-month trial basis by PIC/S Participating Authorities.
The purpose of this draft document is to provide guidance on evaluating and demonstrating the effectiveness of a PQS in relation to risk-based change management. This is in recognition of the fact that the PIC/S GMP Guide requires companies to demonstrate the effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities. Further information on the background to this Recommendation and the anticipated benefits of this guidance are provided in PIC/S Concept Note (PS/INF 88/2019).
This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures on a revised version after completion of the trial-period.
To download the draft Recommendation (PI 054-1 (Draft 1)) and the Concept Note (PS/INF 88/2019), please consult the page “Publications” or click on the links below:
Geneva, 20 September 2019: A draft revision of the PIC/S GMP Guide Annex 2 (Manufacture of biological medicinal substances and products for human use) has been prepared by the PIC/S Working Group on revision of Annex 2 established with WHO, led by Francesco Cicirello (Australia / TGA) and by the PIC/S Sub-Committee on GMDP Harmonisation, led by Paul Gustafson (Canada / ROEB).
This revision is subject to a focused stakeholder consultation which includes both consultation questions and an opportunity to comment on:
Draft Annex 2A takes into account the international development in the regulation of Advanced Therapy Medicinal Products (ATMP) with particular attention to the European Commission guideline on GMP for ATMP which has been published since the latest revision of the EU Annex 2, while addressing at the same time concerns of PIC/S Participating Authorities with regard to patient safety and proportionate regulation for ATMPs. Draft Annex 2B is the revised version of EU Annex 2 for biologics (excluding ATMPs).
This consultation will also allow PIC/S to collect feedback from stakeholders to help PIC/S develop its thinking in this area. PIC/S recognises that this is a rapidly developing industry and the revision being developed represents an intention of PIC/S to consider:
- issues that stakeholders including (academia, hospitals, subject matter experts or the pharmaceutical industry SMEs)
are facing in the international context; and
- how harmonised international GMP standards can help to facilitate manufacturing of these products, especially in
consideration of the increasing manufacturing that occur cross-border.
The consultation period will last 3 months and run from 20 September 2019 to 20 December 2019.
To submit feedback, please provide feedback exclusively on the dedicated Consultation Notice (PS/INF 24/2019) and submit in Word format (not PDF) by e-mail with subject line "PIC/S Focused Public Consultation - Revision Annex 2" to one of the following associations which will collect and compile responses. Stakeholders should only reply once.
To download the Consultation Notice (PS/INF 24/2019) and the Draft Annexes 2A and 2B (PS/INF 25/2019 (Rev. 1) and PS/INF 26/2019 (Rev. 1)) please consult the page “Publications” or click on the links below: