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.
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ISPE plans to comment on the FDA draft guidance for industry titled “Field Alert Report Submission: Questions and Answer” and welcomes input from our Members.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 firstname.lastname@example.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According to the Federal Register Notice, this draft guidance “when finalized, will provide the Agency's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug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 The draft guidance also addresses certain frequently asked questions about FARs.
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 email@example.com 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.
For more information or to suggest a document for comment, contact firstname.lastname@example.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.