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 ...
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