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# PhRMA Expresses ICH Q12 Guidance Concerns
- URL: https://www.fdaweb.com/phrma-expresses-ich-q12-guidance-concerns/
- Published: 2023-01-11T12:00:00.000Z
- Updated: 2026-09-14T18:11:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153514

Pharmaceutical Research and Manufacturers of America (PhRMA) says it has some concerns about the practical implementation of the International Council for Harmonization Q12 guidance on implementation considerations for FDA-regulated products. It also says it has concerns about the implications for industry’s ability to maintain global submission.

In a comment [letter](https://downloads.regulations.gov/FDA-2021-D-0166-0019/attachment%5F1.pdf?ref=fdaweb.com), PhRMA says it generally welcomes the guidance and sees it as clear and positive.

“PhRMA recommends that FDA revise the draft guidance to ensure that companies can submit the same dossier to authorities in different regions, including those countries that may not have yet adopted established conditions,” the letter says.