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. If you would like to submit comments for consideration, please submit them to regulatorycomments@ispe.org by close of business on the dates indicated below. All comments must be received in the associated comment template to be considered.

All comments received will be vetted by a task team of subject matter experts and by the Regulatory Quality Harmonization Committee (RQHC).

Before you submit your comments, please review ISPE’s Commenting Guidelines below.


WHO “Production of Water for Injection by Means Other Than Distillation”

Comments due to ISPE: March 18, 2019

This document provides guidance for the production of Water for Injection (WFI) by means other than distillation. The principles may be applied to other qualities of water produced, meeting other specifications.

Draft Guidance         Commenting Template 


FDA draft Guidance “Principles of Premarket Pathways for Combination Products”

Comments due to ISPE: March 27, 2019

This draft guidance presents FDA's current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate.

Draft Guidance         Commenting Template


EMA “Guideline on the quality of water for pharmaceutical use”

Comments due to ISPE: April 3, 2019

The guideline addresses development, manufacturing and quality control, featuring sections on quality documentation (including parts on the active substance and the investigational medicinal product), non-clinical documentation and clinical documentation.

Consultation Document          Commenting Template


FDA draft Guidance “Quality Considerations for Continuous Manufacturing”

Comments due to ISPE: April 3, 2019

This draft guidance provides information regarding FDA's current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER).

Draft Guidance         Commenting Template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