BIO
Mingping Zhang
Vice President, Regulatory Consulting
With 20 years of Chinese chemistry, manufacturing, and controls (CMC) and regulatory experience, Mingping is responsible for providing China regulatory and CMC consulting services, including global-to-China and China-to-global strategies and CMC gap analysis for China registration. Mingping has held numerous regulatory strategy positions including CMC reviewer, CFDA; vice president, Suzhou Ribo; regulatory CMC manager, Novartis; CMC director, BeiGene; R&D-based Pharmaceutical Association Committee council member; CMC Focus Group member; chair of ISPE China Regulatory & Compliance Committee; and associate chair of ISPE China.
Education
He holds a master’s degree in chemical engineering from National University of Singapore and a bachelor’s degree in biochemical engineering from Beijing University.
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EXCLUSIVE
Playbook
Navigating regulatory divides: Strategic diplomacy in rare hematology
Blog
Optimize your post-approval CMC change management in China with the ICH Q12 tool
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Accelerate global drug development: Navigating China's evolving pharmaceutical regulatory landscape
Webinar
Accelerate global drug development: Leveraging China regulatory changes
Article
Regulation pathway/strategy: Key considerations for foreign medical product registration in China
Blog
Optimize your CMC strategy: Five steps to avoid regulatory setbacks
Blog
Biosimilar reference medicinal product (RMP) regulatory requirements: China, US and EU comparison
Blog
Exploring China’s new pilot regulatory program for rare disease drug development
Blog
New China CDE guidance on platform validation of viral clearance aligns with FDA and EMA
Article
Five regulatory pitfalls for cell and gene therapies in the US, EU, and China, and how to avoid them
Article
How to navigate a cell or gene therapy through China’s two-tier regulatory system
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Adoption of the ICH Q12 guideline: New Horizons for Efficient Product Supply Chain Management for a Key Global Market
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