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.
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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:
Why should you Attend:
- 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
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:
Who Will Benefit:
- 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
- Commercial Managers
- Regulatory Affairs Professionals
- Operations Managers