2016-12-29 Return list
China has decided to reform its appraisal and approval system for drugs and medical instruments with the aim of improving drug safety and quality and encouraging innovation.
According to a guideline issued by the State Council on Aug 18, China aims to set up a more scientific and efficient system to ensure the safety and quality of medicines and medical instruments that come into the market.
The relevant authorities 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.
In order to achieve these goals, the State Council requested that the approval standards for medicines should be improved by adjusting the classification of drug registration. The appraisal and approval process of innovative drugs will be accelerated, including drugs to treat AIDS, cancer, serious infectious and rare diseases.
Institutions and staff involved in the research and development of drugs will be allowed to apply for the registration of new drugs. And, once these drugs are transferred to enterprises for manufacturing, no further appraisal will be required.
Approvals concerning the clinical trials of drugs and medical instruments will be further improved. Additionally, procedures on drug approvals will be simplified, so that applications for drugs and relevant packing and materials will be approved at the same time.
In order to enhance the transparency of approvals, information concerning drug supply and demand, as well as registration applications, will be released in a timely manner. The public will be able to view the list of approvals and make enquiries, if required, and applicants will also be informed of the approval process and results.
Supervision over clinical trials will be strengthened to ensure data authenticity and, during the application process, any fraudulent activity concerning research, standards and data will be severely punished.
The quality of drug appraisals will be ensured by formulating rules with reference to international standards and establishing a professional appraisal team.
The State Council also requested relevant laws and regulations to be amended as soon as possible, during the reform process, and approval charges must also be adjusted, with small and micro- enterprises given priority.