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 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).  All comments accepted for inclusion in the ISPE comments will be anonymized unless explicitly noted below. Please be aware that comments may be edited and/or combined.

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

WHO Draft “Good Storage and Distribution Practices”

This document lays down guidelines for the storage and distribution of medical products. Depending on the national and regional legislation, these guidelines may apply equally to products for human and for veterinary use. The guidelines thus cover products for which a prescription is required by the patient, products which may be provided to a patient without a prescription, biologicals, vaccines and medical devices.

Comments due to ISPE: May 22, 2019

Draft Document     Comment Template

FDA Draft “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C - Guidance for Industry and FDA Staff’

The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices.

Comments due to ISPE: May 30, 2019

Draft Document     Comment 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

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