Surely, no pharma company can overlook the world’s second largest pharmaceutical market: China. Its huge population has a high demand for healthcare products. In tune with this growing requirement, many changes have been brought in into the healthcare system, which is now more attractive than ever to foreign companies that want to bring in new products to market.
On the one hand, factors such as incentives, such as market exclusivity and acceptance of foreign clinical trial data, are too good to be missed. On the other, foreign pharmaceutical companies also need to be aware of the highly regulated nature of this market.
Yingying Liu, a senior consultant who works for Michor Consulting, will be the speaker at this webinar. Commercial Managers, Regulatory Affairs Professionals and Operations Managers who want to benefit from this learning can enroll for this webinar by visiting https://www.compliance4all.com/control/w_product/~product_id=502758...
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The Chinese regulatory body, formerly CFDA, and now renamed as CNDA, has introduced a series of significant recent changes to the marketing authorization regulations with its large number of guidelines and opinions (in Chinese). At this webinar, Ms. Liu will:
- Summarize the key changes in the legislation
- Provide the new procedures for the marketing authorization application processes in China
- Highlight the key steps during the marketing authorization 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
About the expert: Yingying Liu 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 authorizations 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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