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Biopharmaceuticals and Biotechnology

PIC/S Consultation Information

PIC/S Focused Stakeholders Consultation on Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use and Annex 2B Manufacture of Biological Medicinal Substances and Products for Human Use

 

PIC/S Focused Stakeholders Consultation on Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use and Annex 2B Manufacture of Biological Medicinal Substances and Products for Human Use

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is pleased to announce a consultation to:

  1. Invite comments to be provided on a draft of:
    • PIC/S GMP Guide Annex 2A Manufacture of Advanced Therapy Medicinal Products (ATMP) for Human Use (PS/INF 25/2019 (Rev. 1)) which is essentially based on the existing PIC/S Annex 2 with elements from other international standards that have been published;
    • PIC/S GMP Guide Annex 2B Manufacture of Biological Medicinal Substances and Products for Human use (PS/INF 26/2019 (Rev. 1)) which has been transposed to maintain harmonisation with the revised EU GMP Guide Annex 2 - Manufacture of Biological active substances and Medicinal Products for Human Use as published in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines.
  1. Collect feedback from stakeholders to help PIC/S develop its thinking in the area of ATMP recognising that this is a rapidly developing industry and that the PIC/S document being developed represents an intention of PIC/S to consider:
    • issues that stakeholders (including academia, hospitals, subject matter experts or the pharmaceutical industry subject matter experts) 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.

Since the current PIC/S GMP Guide Annex 2 Manufacture of biological medicinal substances and products for human use entered into force, scientific progress has been made in the field. New technologies are now available impacting not only on manufacturing processes but also the location of manufacture which may be performed in non-traditional manufacturing settings. These new technologies and the non-traditional manufacturing settings call for a review of the good manufacturing practices applied to ATMP products including advance therapy investigational medicinal products (ATIMP). ATMP and ATIMP mean any of the following medicinal products for human use: gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered medicinal products.

With many of these products under development and approaching marketing authorisation specific quality issues may need to be incorporated into guidance. PIC/S has proposed two separate Annexes (2A and 2B) that will work together with other existing PIC/S Guides and Annexes to detail good manufacturing practices.

To facilitate development of a PIC/S thinking in the field of ATMP your feedback is welcomed on a number of aspects described in the Consultation Notice below (see questions 1 to 9).

Download

Download the draft versions of the PIC/S Annex 2A and Annex 2B

Manufacture of ATMP Manufacture of biological medicinals
Please Note:

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.

Consultation Notice (PS/INF 24/2019)

 
PDA
Parenteral Drug Association

Send to: [email protected]

ECA
European Compliance Academy Foundation

Send to: [email protected]

IFPMA
International Federation of Pharmaceutical Manufacturers & Associations

Send to: [email protected]

ISCT
International Society for Cell & Gene Therapy

Send to: [email protected]

ISPE
International Society for Pharmaceutical Engineering

Send to: [email protected]

SQA
Society of Quality Assurance

Send to: [email protected]