Navigating the Chinese regulatory landscape: Key considerations for achieving fast track approvals in a rapidly developing market - Amsterdam
October 05, 2018
PAREXEL experts will provide current guidance on a range of topics critical to achieving long-term success when considering how to access the emerging market potential in China for pharmaceuticals, biologics and medical devices.
Areas of discussion will include:
- Current priority review expectations in China and how these can be leveraged to expedite review and approval
- The new "fast track" approval pathway that the Chinese Center for Drug Evaluation (CDE) implemented recently, that uses existing clinical data for drugs that have been approved outside of China
- As part of the "fast track" pathway, the advantages of orphan drugs and breakthrough therapies (including medicines for treating serious life threating diseases), as well as those drugs that can meet unmet medical needs or have shown significant improvement over existing options
Our former CFDA and US FDA experts can also provide insights on the following topics:
- Critical considerations for biosimilar product development in the United States and China
- Effectively managing the current expectations for developing a complex generic drug
- Current medical reimbursement policies in China
- Key considerations when developing an orphan drug or an oncology product
- How developments in China’s digital health policy and practice may impact organizational decisions
Our PAREXEL clinical and regulatory experts can help to navigate the current CDE processes and guide you every step of the way to bring your products into the China market in an efficient and cost-effective way.
Featured PAREXEL speakers:
- Victor Cheng, Vice President, Technical, PAREXEL Consulting
- Yuexia Li, Vice President, Technical, PAREXEL Consulting
Presentations will take place from 10 a.m. – 11:30 a.m. and will be followed by lunch. To register, please complete the information below. You also have the option to meet with one of our subject-matter experts after the presentation.