CFDA consecutively issued new policies to lift controls over medical device and clinical trials

China Food and Drug Administration (CFDA) consecutively issued four reform policies (drafts for comment) on May 11 to solicit public opinions from the society.

Separately being:

1.        Policy on Encouraging Pharmaceutical Product and Medical Device Innovation: Implementing Pharmaceutical Product and Medical Device Lifecycle Management (Draft for Comment);

2.        Policy on Encouraging Pharmaceutical Product and Medical Device Innovation: Protecting Rights and Interests of Innovators (Draft for Comment);

3.        Policy on Encouraging Pharmaceutical Product and Medical Device Innovation: Reforming Clinical Trial Management (Draft for Comment);

4.        Policy on Encouraging Pharmaceutical Product and Medical Device Innovation: Accelerating Review and Approval of Marketing of New Drugs and Medical Devices (Draft for Comment).

The same target of the four Drafts for Comment is to encourage pharmaceutical product and medical device innovation. The great efforts of CFDA this time will hopefully form a big plus for Chinese innovative medical devices. And there are many important measures to lift controls, including:

1.       Lifting controls over clinical trial institutions

"Change clinical trial institution qualification recognition to filing management, and cancel such recognition. After registration and filing on the websites designated by the food and drug administration department, all medical institutions with clinical trial conditions can accept applicants’ entrustment to conduct clinical trials. Social capital is encouraged to be invested in the establishment of clinical trial institutions to provide clinical trial professional services."

——The existing bottlenecks are expected to be broken through thanks to the lifting of controls over clinical trial institutions, however, after filing management, the checking on the clinical trial data will be strengthened, to maintain the authenticity and stop fabrication.

2.    Lifting controls over participation of hospitals and doctors in clinical trials

"Medical institutions, medical research institutions, and medical colleges and universities are supported to participate in clinical trials, and the conditions for and ability in clinical trials will be included in the level appraisal of medical institutions, and treated as important indicators in recognition of clinical key discipline. 3A-grade medical institutions, and hospitals affiliated to undergraduate medical schools of province and above are encouraged to undertake the clinical trial work. Medical institutions are encouraged to establish special clinical trial departments and staff professional clinical trial personnel. Clinicians are encouraged to participate in the pharmaceutical product and medical device technological innovation activities. And medical personnel who conduct clinical trials shall be treated equally with clinicians in post promotion and professional title promotion, etc. Income level of the clinical trial researchers shall be guaranteed by combining with and improving the unit performance salary distribution and incentive mechanisms."

3. Lifting controls over clinical trial review procedure

"Before conducting the medical device clinical trial required approval, such trial shall be formally applied for and accepted upon meeting and communication of the applicant and the review institution. The review institution will be deemed as agreeing to the trial if it does not negate or question the trial within 60 working days from the acceptance date, and the applicant can conduct the clinical trial according to the protocol submitted."

——No negation means agreeing. The clinical trial approval progress is expected to be further accelerated.

4. Lifting controls over overseas clinical trial data in China

"Overseas clinical trial data are accepted. If the clinical trial data obtained by the applicant overseas meet relevant requirements for Chinese pharmaceutical product and medical device registration, such data can be used for registration application in China upon site inspection. For the medical devices of applicants approved to be marketed overseas (except the medical devices of Class III required clinical trial approval), the clinical trial data submitted when they are approved to be marketed overseas can serve as the clinical trial information and be used for medical device registration application in China."

——This is conductive to the synchronous marketing of Chinese and overseas innovative medical devices.

5. Lifting controls over approval of clinically imperative and technologically innovative medical devices

"For the pharmaceutical products and medical devices that treat severe life-threatening diseases currently without effective treatment means and other pharmaceutical products and medical devices that are of great significance to solving clinical demands, if their clinical trial early and mid-term indicators show efficacy and can predict their clinical value, they can be conditionally approved to be marketed in China. R&D of innovative drugs and medical devices are encouraged. The innovative drugs and medical devices listed in China’s National Science and Technology Major Projects or supported by China’s National Key Research and Development Programs can be offered priority review and approval."

——The approval and marketing of medical devices that are clinically imperative and recognized by China as technologically innovative will be accelerated.

6. Lifting controls over R&D and approval of medical devices for rare diseases

"R&D of drugs and medical devices for rare diseases are supported. The health and family planning department shall publish the catalog of rare diseases, and establish the rare disease patient registration system. Applicants of drugs and medical devices for rare diseases can file the application for clinical trial waiver, to accelerate the review and approval of drugs and medical devices for rare diseases. The drugs and medical devices for rare diseases approved to be marketed overseas can be conditionally approved to be marketed in China, with the relevant research made up in the specified time after the marketing."