Approval system reform for drugs and medical instruments in China
China has opted 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 18 August, China aims to set up a more scientific and efficient system to ensure the safety and quality of medicines and medical instruments that come onto 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.
To achieve these goals, the State Council requested that the approval standards for medicines should be improved by adjusting the drug registration classification system. The appraisal and approval process for innovative drugs will be accelerated, including drugs to treat AIDS, cancer, infectious and rare diseases.
Institutions and staff involved in the research and development of drugs will be allowed to apply to register new drugs. And, once these drugs reach manufacturing stage, no further appraisal will be required.
Approvals concerning clinical trials and medical instruments will also be improved. Additionally, drug approval procedures will be simplified, so that applications for drug, packaging and relevant materials can be approved at the same time.
To enhance process transparency, 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.
Clinical trial supervision will be strengthened to ensure data authenticity and, during the application process, any fraudulent activity concerning research, standards and data will be severely punished. Implementing regulations that comply with international standards will ensure the quality of drug appraisals.
