Grace Fu Palma, founder and CEO of Boston-based China Med Device (http://www.ChinaMedDevice.com), a firm specializing in commercialization and funding for U.S. medtech companies entering China, offers new updates on CFDA clinical trial reform in China by CFDA. China Med Device specializing in providing turn-key solution for medtech companies, brings you up to date information on CFDA. If you have any feedback, please e-mail to firstname.lastname@example.org.
On May 11, 2017, the State Food and Drug Administration issued a notice (Opinion No. 53 of 2017) on the "Policy on Encouraging the Reform of Clinical Trials of Drugs and Devices Innovations" (draft). The "draft" is to further deepen the review and approval system reform, promote the pharmaceutical and medical device industries restructuring and technological innovation, improve industrial competitiveness, and to meet the public needs.
1. Accreditation approval to letter to file: the clinical trial institution qualification approval has been changed from the original accreditation process by CFDA to a simple letter to file at the designated registration website. The reform intends to encourage social capital investment to set up clinical trial institutions and to provide clinical trial professional services. The main investigators should have a senior title and have participated in more than three clinical trials. Clinical trial Applicants may employ a third party to evaluate the accreditation of the clinical trial institution. The supervision and validation will be shifted on-site inspection by CFDA officials. The inspection results will be announced to the public. Failure to pass the examination of the clinical trial project, the relevant data will be rejected by CFDA.
We are monitoring closely the current initiative taken by CFDA to reform its registration and regulatory policies and believe this reform should positively impact medical device entry to China by US and international medtech companies:
On May 11, the CFDA released three documents for public comment aiming to reform clinical trial management; accelerate review and approval process; and implement full life-cycle management; for encouraging pharmaceutical and medical device Innovation. These three documents mark a big step forward for the CFDA in reforming the registration system for pharmaceutical and medical devices and reflect some of the major issues that the industry has been advocating on for decades. On May 12, the CFDA further released Policies on Protecting Innovator’s Interests for Encouraging Pharmaceutical and Medical Device Innovation, to establish a pharmaceutical patent linkage system and improve test data protection system. The systems and measures proposed in this draft provide more detailed regulations for enforcing existing measures, showing the CFDA’s determination in further strengthening IPR protection and creating an atmosphere that rewards innovation...
In this month, CFDA released three documents for public comment: 1) Policies on Reforming Clinical Trial Management for Encouraging Pharmaceutical and Medical Device Innovation; 2) Policies on Accelerating Review and Approval Process for Encouraging Pharmaceutical and Medical Device Innovation; 3) Polices on Implementing Full Life-Cycle Management for Encouraging Pharmaceutical and Medical Device Innovation. According to the CFDA, these three documents aim to further deepen registration reform, promote industrial upgrade and innovation in the pharmaceutical and medical device sector, and meet increasing clinical needs.
Contact China Med Device (CMD) team if you would like to know more about CFDA's registration and policy reform and get immediate help to accelerate your device's market entry in China. Please call us 978-390-4453 or email info@ChinaMedDevice.com.
Click here to find out more about CMD's turn-key China regulatory services for your medical device.