Regulatory Commenting

As regulatory agencies invite public comment on a new or revised regulation or guidance they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we can provide that scientific/technical input.

ISPE plans to comment on the documents listed below and welcomes input from ISPE Members. All ISPE comments will be vetted by a task team of subject matter experts and by the Regulatory Quality Harmonization Committee (RQHC). Please be aware that comments may be edited and/or combined. Only comments accepted for inclusion in the ISPE comments will be anonymized before submission to the Health Authority.

Current Commenting Activity

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) announced a consultation to:

  1. Invite comments 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.
  2. Collect feedback from stakeholders to help PIC/S develop its thinking in the area of ATMP recognizing 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.

The consultation period will run from 20 September 2019 to 20 December 2019.

To Submit Feedback:

Send the comment template below (as a Word document, not a PDF) with the subject line "PIC/S Focused Public Consultation – Revision Annex 2" to regulatorycomments@ispe.orgby close of business on 20 December 2019. All feedback must be received in the dedicated template for consideration.

Subscribe to the ISPE Regulatory and Quality Networking Community to receive notice of ISPE commenting opportunities.

Commenting Guidelines:

  1. Comments should provide technical, scientific feedback to help the agency improve the document, and must include sound justification for any suggested change(s). Language appropriate for a business interaction should be used.
  2. Comments must be specific and include language that could be substituted for what the regulators propose.  For example, a comment of “This is unclear” without providing an explanation and proposed replacement language will generally be eliminated.
  3. Comments should be limited to what is in contained in the document and should not introduce additional regulations to the document. Comments proposing additional regulations will be eliminated from consideration.
  4. If the guidance is a revision to a current guidance, focus comments on the new items in the regulation/ guidance rather than on the existing sections that remain unchanged (applies to documents which have been previously released by the agency). This is generally most relevant for EMA publications.
  5. Identify either the line or section on which you are commenting. In most cases the comment template will provide the structure.
  6. Provide the information requested in each column of the comment template. Comments lacking any requested information will be eliminated from consideration.
  7. If the incorrect grammar in a document could result in a misinterpretation of the requirements, then please note it.  If not, and if there are many grammatical errors, a single suggestion that the “…grammar should be reviewed and edited as necessary prior to issuance of the final document” is an appropriate comment to be made one time.
  8. When making reference to other regulations/guidance, be specific and provide the official title and publication date where relevant either within the text or as a footnote.
  9. Avoid comparing the document under consideration to a similar one published by another regulatory authority.  While this is important to do internally within a company, it’s not generally met with any favor by the regulatory authorities.
  10. Check and correct grammar, punctuation and spelling before submitting for review.  Comments should be publication-ready when you are done.

For more information or to suggest a document for comment, contact

ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC). The Regulatory Quality Harmonization Committee welcomes inquiries from ISPE members or groups who wish to comment on a document through ISPE.

  • The Regulatory Quality Harmonization Committee determines whether the document falls within the scope of ISPE commentary
  • A team of subject matter experts are convened to lead the comment development
  • Final comments are vetted by ISPE regulatory leadership prior to submission

View Regulatory Comments