CMC Archives

What is changing in China CMC regulatory?

Jun 2022 |

BioPhorum’s Post-Approval Strategy Team has produced a poster titled What is changing in China CMC Regulatory? It refers to a wide range of changes in areas such as pharmacopeia, e.g., more convergent monographs in CHP 2020 than any other version of the Chinese Pharmacopeia. It also talks about changes in submissions, including excipients and primary packaging materials need to be registered on the Chinese Drug Master File platform before use in products. It can be used by BioPhorum member organizations, displayed in a CMC regulatory office, used at CMC meetings, and shared with colleagues outside the regulatory function.

Speed to clinic benchmarking survey final report

Apr 2022 | Accelerate CMC Development to Marketing Application, Benchmarking, COVID 19, Deliverable, Deliverables Report, Development Group, Publication

A comprehensive benchmarking survey aimed at collating data on the technical practices involved in therapeutic protein production and evaluation of if/how this has changed in response to the COVID-19 pandemic.

Clinically relevant specifications setting benchmarking survey

Mar 2022 | Accelerate CMC Development to Marketing Application, Benchmarking, CMC Regulatory, Deliverable, Deliverables Report, Development Group

A BioPhorum member only survey gathering feedback on initial submission Biologics License Applications (BLA) / Marketing Authorization Application (MAA) supplement/variation, etc.) and the outcome of health authority review and approval of the submission.

Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

Oct 2021 | Drug Substance, Feedback to agency, Post Approval Strategies, Regulatory

The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. This document in the industry response to an agency consultation on draft guidance on ICH Q12. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.

Trends in outsourcing of CMC development services for biologics

Jan 2021 | CMC Regulatory, Deliverable, Development Group, Publication

The interplay, engagement and interactions between Sponsor and C(D)MO are frequently considered, presented and discussed at the BioPhorum Development Group, a gathering of more than 20 global biopharmaceutical companies, representing both Sponsor and C(D)MO organizations, with a focus on chemistry, manufacturing and controls (CMC)-related clinical biopharmaceutical development, testing and manufacture. This self-survey was aimed at understanding outsourcing approaches and governance and focused on analytical development and testing, process development and manufacturing, project management and governance and quality system and regulatory support. From the aggregate survey responses in each area, key trends were identified, providing insights to potential best practices

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Viewing related articles

What is changing in China CMC regulatory?

Speed to clinic benchmarking survey final report

Clinically relevant specifications setting benchmarking survey

Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

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