Accelerate global drug development: Leveraging China regulatory changes
China's pharmaceutical regulatory environment continues to evolve rapidly, creating both opportunities and challenges for global companies. Our recent webinar provided essential insights into these changes and practical strategies for success.
What You'll Learn
Our expert-led session covered:
- Streamlined Approval Pathways: How China's reformed Clinical Trial Application process is reducing development timelines and creating new opportunities for global sponsors
- Strategic Use of Foreign Data: Practical approaches for meeting NMPA requirements when leveraging global clinical data in Chinese submissions
- Breakthrough Therapy Strategies: Evidence-based guidance on qualifying for expedited review pathways, illustrated through Parexel-supported case studies
- Therapeutic Area Focus: Specialized regulatory considerations for rare disease and oncology products, with comparative analysis of Chinese and US frameworks
Understanding China's unique regulatory framework is essential for pharmaceutical companies looking to access one of the world's most significant and rapidly growing pharmaceutical markets. Our webinar provides the strategic insights needed to navigate this complex landscape efficiently and accelerate your global development programs.
Related Insights
Webinar
Latest updates from EU: Develop Once, Access Europe: The Power of Joint Clinical Assessment (JCA)
Aug 13, 2025
Whitepaper
Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
Sep 19, 2023
Whitepaper
The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations
Mar 9, 2023
Playbook
Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success
Mar 28, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Article
The technologies that are reshaping biotherapeutics manufacturing, an EU perspective
Jul 6, 2023
Blog
Ensuring future success in a new market by delivering a robust safety database solution
Aug 4, 2023
Related Insights
Webinar
Latest updates from EU: Develop Once, Access Europe: The Power of Joint Clinical Assessment (JCA)
Aug 13, 2025
Whitepaper
Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
Sep 19, 2023
Whitepaper
The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations
Mar 9, 2023
Playbook
Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success
Mar 28, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Article
The technologies that are reshaping biotherapeutics manufacturing, an EU perspective
Jul 6, 2023
Blog
Ensuring future success in a new market by delivering a robust safety database solution
Aug 4, 2023