Pharmaceutical Drug Registration in China

This webinar will Summarise the key changes in the legislation, and Provide the new procedures for the marketing authorisation application processes in China, Also will Suggest best practices when interacting with the regulatory authorities, such as the Center of Drug, China has become the 2nd largest pharmaceutical market in the world, with a large population in need of healthcare products.

Yingying Liu
Instructor:
Yingying Liu
Duration:
90 Minutes
Product Id:
502112
Access:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options
Overview:

Bringing pharmaceutical products to market in China has become much easier for foreign companies. The Chinese FDA (CFDA), now renamed as CNDA, recently made a series of significant changes to the marketing authorisation regulations by issuing a large number of guidelines and opinions (in Chinese).

This webinar will:

  • Summarise the key changes in the legislation
  • Provide the new procedures for the marketing authorisation application processes in China
  • Highlight the key steps during the marketing authorisation procedure
  • Will address specific issues, such as:
    • sample testing
    • bundling review for API, excipients and packaging material
    • priority review and accelerated approval
  • Suggest best practices when interacting with the regulatory authorities, such as the Center of Drug Evaluation (CDE) or the testing agency
  • Provide an opportunity to ask very specific questions about the NDA process for any type of drugs

Why should you Attend: China has become the 2nd largest pharmaceutical market in the world, with a large population in need of healthcare products. The healthcare system has undergone changes to make it more attractive to foreign companies, bringing new products to market.

There are incentives, such as market exclusivity and acceptance of foreign clinical trial data, that must be taken into account. Don't miss the chance to enter this highly lucrative, but also highly regulated market, by listening to the succinct summary of the registration procedures in this webinar.

Areas Covered in the Session:
  • The new pharmaceutical drug marketing authorisation procedures
  • Timelines, requirements and relevant strategies
  • Comparison with the previous regulations
  • Communication strategies with the regulatory authorities
  • Links to the new regulations and guidelines

Who Will Benefit:
  • Commercial Managers
  • Regulatory Affairs Professionals
  • Operations Managers


Speaker Profile
Yingying Liu is a senior consultant working for Michor Consulting. She is an experienced Regulatory Affairs professional with a background in pharmaceutical science and technology. Yingying has worked on local and global projects for various blue-chip healthcare companies in China. She assisted a wide range of global clients obtaining clinical trial authorisations and bringing their products to market in China, and provided regulatory consultation to clients interested in registering or importing drugs or devices into China. In particular, she helped facilitate meetings and interactions with the China regulatory authorities.


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