After issuing the Prime Minister Li Keqiang recently issued "on the reform of the drug review and approval system for medical devices opinions" (hereinafter referred to as "Opinion") of the State Council. "Opinions" stressed the urgent need to accelerate the clinical review and approval of new drugs, new drug application for registration of companies to commit to their products in our sale price is not higher than the surrounding country of origin or country of comparable market prices.

In recent years, medical review of drug approval in the problems have become increasingly prominent, mainly drug registration declare a serious backlog, some innovative drugs market approval time is too long, there is some quality of generic drugs is a big gap with the international advanced level. These issues have a profound historical reasons, institutions and mechanisms and other aspects.

"Opinions" to define the 12 task of reform, including improving the drug approval standards, accelerate innovation drug review and approval, and severely punish registration falsifications, simplify drug approval procedures, improve the drug re-registration system. Among them, the "Opinions" clear that the implementation of the special review and approval system for innovative drugs. Drug Evaluation accelerate approval of innovative drugs to combat AIDS, cancer, major infectious diseases, rare diseases and other diseases included in the national science and technology major projects and key national development plans, be transferred to the territory of the production of innovative drugs and child medication, and the use of advanced formulation technology, innovation treatment, have significant therapeutic advantages of innovative drugs.

Accelerated approval, drug quality will not be affected? In this regard, the State Food and Drug Administration of Wu Zhen, deputy director of the commitment, on the review of the issue to be fast, but more is better. "On this issue, we will not change, can not change, did not dare to change." Wu Zhen said that speed the process, definitely put quality in the first place, the people's health in the first place.