State Council Issues Guidelines for Reform of Drug and Medical Device Evaluation and Approval System

The State Council recently issued the Opinions on Reforming the Drug and Medical Device Evaluation and Approval System (see details in Chinese), clearly setting out the goals, tasks and specific measures for the reform of the evaluation and approval of drugs and medical devices.

The Opinions pointed out: China's pharmaceutical industry has witnessed rapid development in recent years. Members of the public are generally quite satisfied with the drugs and medical devices produced thanks to the continuous improvements made in their quality and standards. However, problems existing in their evaluation and approval are also becoming increasingly prominent. Some new drugs are taking too long to gain marketing approval, and the quality of some generic drugs is trailing way behind international advanced standards. These problems have deep historical roots and are related to systems and mechanisms.

China has gone through times when drugs were in acute shortage. The modern pharmaceutical industry has had a late start and the standard remains relatively low. For many years, the government has adopted a series of measures to improve the quality of drugs, such as subjecting to unified state approval all drugs which only required approval by the local authorities, raising the drug standards from local to national, raising the level of GMP certification, and promoting the consistency evaluation of the quality and curative effect of generic and brand-name drugs. However, the drug approval standards remain low, administration remains backward, the evaluation and approval system is not running smoothly, and the mechanism remains unreasonable. There is repetitive application at a low level by enterprises and some of the clinical data submitted for registration application are inaccurate, incomplete and non-standard. The shortage of evaluation personnel and their poor remuneration are also inconsistent with the requirements for handling registration applications.

The 12 reform tasks specified in the Opinions include: Raise the drug approval standards; promote the quality consistency evaluation of generic drugs; accelerate the evaluation and approval of new drugs; pilot the drug marketing authorisation holder system that requires the applicant to assume the main liability; release information on drug supply and demand and registration application in a timely manner; improve the approval system of the clinical testing of drugs; strictly investigate and punish frauds in registration application; simplify the drug approval procedures; improve the drug re-registration system; reform the approval of medical devices; strengthen the evaluation and quality control system; and fully make public all information on the evaluation and approval of drugs and medical devices.

In order to carry out the above-mentioned reforms, the State Food and Drug Administration is stepping up the amendment of the Implementing Regulations for the Drug Administration Law and the Measures for the Administration of Drug Registration, recruiting technical evaluation officers, strengthening the building of the evaluation team, and promoting the building of the team of professional inspectors.