ICH Q12: BIO Comments on ICH Q12 Draft Guideline

December 12, 2018

Re: Docket No. FDA-2018-D-1609: Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Draft Guideline or Guideline).

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonization of critical regulatory concepts is an important part of ensuring a consistent and predictable regulatory environment and gives sponsors confidence that their drug development program will be generally accepted within different regions. BIO believes that the concepts in Q12 are important and warrant broad recognition across the globe.

In general, we believe the Draft Guideline is based on good philosophical concepts which could potentially provide useful regulatory tools and enablers such as Established Conditions (ECs), Post-Approval Change Management Protocols (PACMPs) and Post-Approval Lifecycle Management (PLCM); these tools and enablers should subsequently increase the predictability and efficiency of post approval CMC changes.

While we are encouraged by the work of the ICH Q12 working group, we are most concerned that many important concepts may not be able to be implemented in some regions. We offer both comments on high priority topics in the below letter and additional detailed comments in the tables that follow.

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