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