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 ICHQ12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and welcomes input from our Members. If you would like to submit comments for consideration, please submit your comments to regulatorycomments@ispe.org by close of business on 7 September 2018. All comments must be received in the comment table to be considered.

ICH states that this new guideline is proposed to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Adoption of this new ICH Guideline will promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will allow regulators (assessors and inspectors) to better understand the firms Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and includes a core Guideline as well as Annexes.

All comments received will be vetted by a task team of subject matter experts.

Please note: you must use the FDA-posted version linked above. The line numbers in other versions might not align.

ICH Document              Commenting Template


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 regulatoryaffairs@ispe.org.


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