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.  Commenting opportunities are listed below.


Field Alert Report Submission: Questions & Answer

Deadline: 13 September 2018

ISPE plans to comment on the FDA draft guidance for industry titled “Field Alert Report Submission: Questions and Answer” and welcomes input from our Members.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 13 September 2018. All comments must be received in the comment table to be considered.

According to the Federal Register Notice, this draft guidance “when finalized, will provide the Agency's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and will outline FDA's recommendations for FAR submissions to help increase their consistency and relevancy. The draft guidance also addresses certain frequently asked questions about FARs.

Draft Guidance             Commenting Template


ICHQ12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Deadline: 7 September 2018

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. For example, a comment of “This is unclear” is insufficient. If text in the document is unclear, explain why it can be misleading.
  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. Identify either the line or section on which you are commenting. In most cases the comment template will provide the structure.
  5. Provide the information requested in each column of the comment template. Comments lacking any requested information will be eliminated from consideration.
  6. 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.
  7. 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.
  8. The ability to comment on draft regulations is an individual Member benefit; the comments you submit are assumed to be your own, rather than those of your company. Comments submitted on behalf of a company should be identified as such. In the rare case where ISPE receives only comments from one company, they will be considered only if their company is not also submitting the comments to the agency,
  9. Comments that are submitted to ISPE as “on behalf of” an ISPE Technical Community (Community of Practice) must be approved by the chair or co-chair of that community. Only one set of comments will be accepted as “on behalf of” an ISPE Technical Community. 
  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