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What’s changing in the Chinese CMC regulatory environment? 

China is a commercial market with enormous potential for the biopharmaceutical industry but is transitioning from a national regulatory environment to one that is harmonized with the global industry, albeit with some local specifics and complexities. BioPhorum’s Post-Approval Strategy Team has been navigating this new Chinese regulatory environment through its many recent changes. To capture its learnings, the team has produced a poster titled...

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What is changing in China CMC regulatory?

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.

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BioPhorum’s expert feedback on the FDA’s ICH Q12 guideline

The globalization of the supply chain and market for medicinal products are complex areas. They have resulted in a growing number of different procedures, rules and country by country regulations that must be followed whenever post-approval changes to chemistry, manufacturing and controls (CMC) are proposed for various reasons. These regulations can stifle innovation and process improvements that ultimately benefit the patients. ICH guidance...

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

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 This document in the industry response to an agency consultation on draft guidance on ICH Q12.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.

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Outsourcing development services offers solutions for increased demand

Many companies have increasingly sought to outsource chemistry, manufacturing, and controls (CMC) development services. Successful outsourcing has many benefits, such as meeting increased demand, reducing the time to market and improving capacity. However, BioPhorum has found that many companies approach outsourcing differently. To better understand best practices for decision making, governance and management, the group conducted a survey on...

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Trends in outsourcing of CMC development services for biologics

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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Registered content for S.4.2 analytical procedures

Delivered at BioProcess East, Boston, September 2019, this presentation details the conclusions from a survey and discussions about this topic. Designed, completed and discussed by 14 leading biopharmaceutical companies of the CMC Regulatory subteam, the purpose of the survey was to determine companies’ approaches to S.4.2 section content. More specifically what content different companies providing within each subsection of S.4.2 for non-compendial methods, understand to what extent the level of information provided in core dossiers can be aligned between countries, to minimize the need for global document lifecycle management and if specific feedback from any countries been provided to indicate what content is required?

This document is reserved for the use of BioPhorum Members only

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