Clinical Trial Applications in China

Overview:

China FDA (CFDA), now renamed as CNDA, made a series of significant changes to the clinical trial regulations, issuing a large number of guidelines and opinions in Chinese.

As an important stage during medical products development, the regulation in terms of clinical trial in China is experiencing the huge change, reviewing the Clinical trial application (CTA) is no longer like before, which the standard and requirement was much similar to a marketing authorization application.

The reason is simple: to make it much easier for foreign companies to run clinical trials in China. China wants to attract foreign business and is keen to offer a business-friendly regulatory environment.

This webinar will:

• Summarise the key changes in the legislation
• Provide a comparison between the former and the new Clinical Trial Application processes
• Highlight the major benefits for foreign companies to run clinical trials in China
• Address the remaining challenges and pitfalls
• Suggest best practices when interacting with the regulatory authorities, such as the Center of Drug Evaluation (CDE) or the ethics committees
• Provide an opportunity to ask very specific questions about the CTA process for any type of drugs

Why should you Attend: Running clinical trials in China has become much easier. This is a highly attractive market for foreign companies, which has just become even more attractive. Opportunities and pitfalls abound.

Areas Covered in the Session:

• The new CTA process
• Timelines, requirements and relevant strategies
• Comparison with the previous regulations
• Communication strategies with the regulatory authorities
• Links to the new regulations and guidances

Who Will Benefit:

• Clinical Trial Managers
• Regulatory Affairs Professionals
• Medical Officers

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.