Professional Training

Pharmaceutical Regulatory Affairs in China

PTI, Online
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Course description

Pharmaceutical Regulatory Affairs in China

Develop or market your drug in China more effectively with a deep understanding of the Chinese pharmaceutical regulatory landscape. In 2015 China’s pharmaceutical sector underwent significant regulatory reforms to align with EMA & FDA requirements, making the Chinese market one of the biggest pharmaceutical markets in the world. The reforms included clinical trial approval time being cut from 2 years to 60 days and the NMPA becoming a member of ICH.

During this course, you will learn fundamental Chinese regulatory requirements for pharmaceuticals and how they relate to the country’s economic and cultural background. Guided by our expert course leader you will discover best practices for registering new drugs and discuss the likely impact of the US – China Trade War on market access and drug development.

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Suitability - Who should attend?

This course is applicable to anyone interested in accessing the Chinese pharmaceutical marketplace.

  • Relevant job titles may include:
    • Heads of Department
    • Directors
    • Managers
    • Consultants
  • Relevant departments may include:
    • Project Management
    • Regulatory Affairs

Training Course Content

  • Understand how China’s cultural and economic background has impacted pharmaceutical regulations
  • Learn about reforms to legislation in China and the reasons behind the changes, including the development of the NMPA and the move to the 60-day clinical trial approval time
  • Learn best practices for successfully registering pharmaceutical products in China and the challenges which coincide with it
  • Familiarise yourself with the regulations governing biopharmaceuticals in China, evaluate the trends and gain an overview of CMC guidance
  • Understand the potential impact of the US-China Trade War on the Chinese pharmaceutical market

Why choose PTI

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