In late August, China’s State Council released new guidelines designed to improve the registration and approval process for drugs and medical devices. The new guidelines will modify the drug registration process by accelerating the investigation and approval procedure for innovative drugs. Innovative drugs include drugs that treat severe infections, rare diseases, AIDS, and cancer.
In addition, institutions involved in the research and development process will be able to directly apply for new pharmaceutical registration. Companies that then manufacture the drugs will not have to submit to any further registration or approval process. The State Council has also worked to accelerate the drug approval process by ensuring that drugs, packaging, and relevant materials will all receive approval at the same time.
While the guidelines will not immediately affect Chinese law, the State Council has requested that the relevant laws and regulations be modified as soon as possible. These modified laws will speed up the registration and approval timeline. By 2018, the State Council hopes that every drug and medical device application will be reviewed and decided on within a certain time frame.