Countries in the world implement strict market access management for drugs. Since the beginning of this year, China has made remarkable progress in accelerating the review and approval of new drugs marketed overseas that are urgently needed in clinical practice. At the regular briefing on the State Council's policies held by the Press Office of the State Council, the head of the China's National Drug Administration (CNDA) introduces the progress of speeding up the review and approval of overseas new drugs and strengthening the supervision.

The time of review and approval has been significantly shortened

Wang Lifeng, head of the Cosmetics Registration Management Department under the CNDA, said at present, there are more than 3,800 overseas drugs approved in China, including more than 3,400 chemical drugs, more than 300 biological products and more than 70 traditional Chinese medicines, which basically cover the main therapeutic fields such as anti-cancer, anti-virus and anti-hypertension.

In terms of the number of drugs approved, an average of 336 clinical trials of imported drugs have been approved each year in the past five years, with an annual increase of 7%. On average, 56 imported drugs are approved to be marketed every year, up 16% annually. For the total time limit of clinical approval and marketing approval, the legal time limit of new drug approval in China is close to that in developed countries.

Wang Lifeng said that since the reform of the drug approval system, the time for drug approval in China has been continuously shortened, and currently the drug approval can be completed within the time limit. In recent years, the approval time of overseas new drugs in China has been significantly shortened, and innovation resources of drugs are clustering in China.

The time expected for drugs to be marketed is shortened

After the review and approval is accelerated, how much shorter will the overseas new drug market time be?

According to Wang Lifeng, seven new overseas drugs to prevent and treat serious life-threatening diseases have been approved to be marketed recently, including the nine-valent human papillomavirus vaccine to prevent cervical cancer and the third-generation Sofosbuvir and Velpatasvir tablets for Hepatitis C. Priority is granted to these new drugs to realize review and approval, thus they can enter China's market two years ahead of schedule.

According to statistics from the CNDA, in the past 10 years, there have been 415 new drugs marketed in the United States, the European Union and Japan, among which 277 have been marketed or have applied for market access in China, accounting for 66.7% of the total.

The CNDA is ready to organize experts to classify a total of 339 new drugs, including 201 are under review and approval procedure and 138 which have not applied for review and approval in China. This move aims to screen drugs for rare diseases, drugs for diseases for which currently there is no effective treatment in China, or drugs with remarkable clinical advantages to prevent and treat serious life-threatening diseases, such as anti-HIV and anti-cancer drugs. Efforts will be concentrated to accelerate the review and approval of the above drugs. It is expected to complete the procedure for drugs for rare diseases within three months, and for other clinical drugs within six months, which will shorten the time forecast by 12 to 24 months.

What are the next steps to accelerate the launch of new drugs? Jiao Hong, Director-general of the CNDA, said that the first step is to adjust the registration and inspection procedures of imported chemicals, turning registration inspection before the launch of the products to supervision and sampling inspection after the products have entered the market, so as to speed up the launch of overseas new drugs. The second step is to implement data protection. According to the clinical trials of overseas new drugs in China, corresponding data protection periods are given respectively. During the protection period, other marketing application of the same type will not be approved. Third, the drug patent linkage and patent term compensation system should be implemented, so as to encourage innovators to gain reasonable expected benefits, strengthen the protection of intellectual property rights, and encourage drug imitation while giving incentives to generics manufacturing.

Efforts should be stepped up to strengthen the whole-process supervision

When approval of drugs is accelerated, supervision must be strengthened. So how to ensure the safety and effectiveness of overseas new drugs after their launch?

Jiao Hong urged to further strengthen the whole-process supervision. First, the responsibilities of the Marketing Authorization Holder (MAH) should be designated. The MAH shall assume full legal responsibility for all aspects including pre-clinical research, clinical trials, manufacturing, sales and distribution, adverse reactions and events. Second, efforts should be made to speed up the cultivation of professional inspector team. Relying on existing resources, a team of professional inspectors should be established which is based on full-time inspectors and supported by part-time inspectors. Third, the sampling inspection of drugs in the market should be strengthened, and the research on inspection campaign should be improved to constantly meet the post-marketing supervision needs of imported drugs. Fourth, the monitoring and reevaluation of adverse reactions of drugs launched in the market should be strengthened, so as to take timely measures such as suspension of sales and withdrawal of drugs with serious adverse reactions.

Overseas inspection refers to the inspection conducted abroad for imported drugs during the period of registration and approval or which have been approved for marketing. Jiao Hong said that the overseas inspection of drugs should be strengthened, which is an important means to get a whole picture of the quality of imported products, inspect the regulatory risks abroad and keep imports safe, so as to ensure the quality and safety of imported drugs, protect the life and health rights of Chinese consumers to the maximum extent, and keep consistent with international standards in supervision.

In recent years, China has found a total of 992 defects in 26 categories in violation of Chinese laws, regulations and standards by overseas drug manufacturers. The CNDA has taken measures to stop the import of 19 imported drugs to ensure the drug use safety of Chinese people.