The Chinese Food and Drug Administration (CFDA) has come under heavy criticism for its slow and inefficient drug review and approval process, which has resulted in a backlog of 18,600 applications. To improve drug review processing, the CFDA recently recommended that pharmaceutical companies with pending drug registrations submit self-audit clinical trial data.
The CFDA will make efforts to strike a balance between the number of registration applications received and those that are approved by the end of 2016. They will also ensure that, by 2018, every application will be approved or rejected within a certain time limit.
China has also decided to reform its appraisal and approval system for drugs with the aim of improving drug safety and quality and encouraging innovation. According to a guideline issued by the State Council on August 18, 2015, China aims to set up a more scientific and efficient system to ensure the safety and quality of medicines that come into the market.
The quality of drug appraisals will be ensured by formulating rules with reference to international standards and establishing a professional appraisal team.