PhRMA, BIO Call for Global Approach on Regulations Governing Manufacturing Changes

Posted 08 January 2016 By Zachary Brennan


The US Food and Drug Administration (FDA) should work more closely with the International Conference on Harmonization (ICH) on the reporting of chemistry, manufacturing and controls (CMC) changes for approved drugs and biologics, according to the industry groups’ comments on proposed FDA draft guidance.

The FDA draft guidance, known as Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products and released in June, lays out new recommendations for how and what CMC changes should be reported and what should be considered an “established condition.”


In comments on the draft (the comment period ended on Monday), industry groups PhRMA and BIO said they support the guidance but FDA should work more closely with ICH to ensure such requirements are globally harmonized.

“PhRMA supports FDA’s intent to focus post-approval regulatory review activities on defined CMC issues so as to ensure that the agency’s resources are dedicated to those review activities that are most critical to the continued availability of high quality, safe and effective medicines. Yet, PhRMA would like to emphasize the need for globally harmonized guidance to this complex issue,” the group said.

The release of the draft guidance comes as the ICH Q12 guideline, known as “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” also provides a framework to facilitate the management of post-approval CMC changes, though it isn’t expected to be fully adopted until Q2 2017.

“PhRMA does not support reviewers in CBER and CDER using this Established Conditions guidance to aid in regulatory decision-making as it relates to pharmaceutical lifecycle management at this juncture,” the group added. “To finalize or put into practice the Established Conditions guidance now could result in considerable duplication of efforts and unnecessary expenditure of resources, as well as undermine open dialogue and efforts to harmonize at ICH. To this end, PhRMA encourages the FDA to not finalize the Established Conditions Guidance until the ICH Q12 guideline has been signed off on by the full ICH Steering Committee.”

PhRMA also is calling for FDA to provide more information on the content in BLA or NDA submissions for integrated drug delivery combination products.

In addition to PhRMA, BIO and biotech companies Gilead and Celgene encouraged the agency to work with ICH on a more global approach for these CMC changes and not adopt the guidance until after Q12 is finalized.

Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Docket

ICH Q12 Final Concept Paper

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Categories: Biologics and biotechnology, Drugs, Manufacturing, Regulatory strategy, News, US, FDA, ICH

Tags: CMC changes, FDA draft guidance, guidance comments

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