Recently, it was learned from the State Medical Insurance Administration that the State Medical Insurance Administration will carry out a 2018 special negotiation on the entry of anticancer drugs for medical insurance. On July 11, 2018, the State Medical Insurance Administration entrusted relevant societies and associations to hold some corporate symposiums and put forward requirements for focusing on tumor therapy, reflecting the value of drug innovation and balancing the interests of enterprises, patients, and other parties. It was noted that ten foreign-funded pharmaceutical enterprises were invited to participate in the forum. Thus, the domestic patients can expect early access to new high-quality & low-priced overseas-launched drugs.

The legal time limit for examination & approval of new drugs in China is close to that of developed countries.

Currently, all countries around the world implement strict market access management on drugs. The examination & approval system is internationally accepted practice. In order to guarantee the safety and effectiveness of drugs used by citizens, strict technical review, clinical trials, and on-site inspection of imported drugs are the common practices of the US, the EU, Japan and other developed countries. Since the promulgation and implementation of the Drug Administration Law in 1985, by learning from the advanced experience of developed countries, China has gradually established a registration approval system in line with internationally accepted practices. It is reported that China has approved more than 3,800 overseas-launched drugs, covering anticancer, antiviral, antihypertensive and other major therapeutic fields. Especially since the beginning of the reform of the drug examination & approval system in China in 2015, the time for drug examination & approval has been shortened continuously, and the examination & approval process can be completed punctually at present. According to the data of the State Food and Drug Administration (SFDA), in terms of the total time limit on clinical approval and launching approval, it takes 390 days in China, 330 days in the US, 270 days in the EU and 330 days in Japan. By and large, China is close to the developed countries in legal time limit on the examination & approval of new drugs. In order to let new overseas-launched drugs benefit domestic patients as early as possible and meet the domestic clinic requirements. For example, in order to allow patients to access new overseas-launched drugs, the State Food and Drug Administration has simplified the approval process for domestic clinical needs, and accelerated the review, examination and approval for urgently needed overseas drugs. In the first half of 2018, the SFDA approved seven overseas-launched new drugs that can prevent and treat serious life-threatening diseases, including the 9-valent HPV vaccine that can protect against cervical cancer, and Epclusa that serves as the G-III product for the treatment of hepatitis C.

Time for overseas-launched new drugs to enter domestic market is gradually shortened.

According to statistics, in the past ten years, altogether 415 new drugs were launched in the US, the EU and Japan respectively, 277 of which were launched in the market or have completed their application in China, accounting for 66.7% of the total. Among these 277 new drugs, 76 have been launched in China, while 201 are in the process of clinical trials or in the application process in China. In order to allow domestic patients to benefit from overseas-launched drugs as early as possible, the SFDA mainly carries out the following work. First, simplify the examination & approval process of the overseas-launched new drugs. In May 2018, the SFDA and the National Health Commission jointly issued the Announcement on Relevant Issues Concerning the Optimization of Drug Registration Review and Approval, simplifying the examination & approval process of overseas-launched new drugs by a large margin. For drugs launched overseas which can prevent and treat serious life-threatening diseases otherwise without effective treatment, as well as rare diseases, and meanwhile have been confirmed by studies there is no ethnic difference, the applicant does not need to apply for clinical trials and can directly apply for launching with overseas test data. By doing so, the time for drug launching will be shortened by 1-2 years. For overseas new drugs that need to be clinically tested in China, the registration inspection in the clinical test period is changed from inspection item by item to inspection according to the review needs, so as to shorten the inspection cycle of the enterprises and thus accelerate the launching process. Second, optimize the approval process for the drug clinical tests. The Announcement on Adjusting the Review & Approval of Drug Clinical Tests (Trial) drafted by the SFDA is soliciting public opinions across the country at present. After the announcement is officially put into effect, the examination & approval system of clinical test applications will be adjusted to the system of default upon expiration. In other words, in the event that the applicant doesn’t receive any negative opinion or query within 60 days upon official acceptance of clinical test application, the applicant can carry out relevant clinical tests in accordance with the submitted application. This can reduce cost and save the time for the enterprise. Third, cancel the batch-by-batch compulsory inspection of imported chemicals. In April 2018, the SFDA issued the Announcement on Relevant Issues Concerning Drug Custom Clearance & Inspection, which cancelled the port inspection of imported chemicals and strengthened the post-launch supervision & sampling inspection of drugs. After the implementation of relevant policies, the imported chemicals after custom clearance can be directly delivered to medical institutions and retail pharmacies. It can shorten the market access time of overseas new drugs by 2-3 months and greatly reduce the market access costs of overseas new drugs in China.

Deepening medical system reform and further strengthening drug supervision

As China’s medical system reform enters a critical stage, the reform has become increasingly difficult, and some problems and contradictions, such as insufficient clinical test institutions and the capacity building of clinical test institutions, require immediate solutions. Moreover, relevant laws and rules on drug test data protection, patent linkage and patent term compensation are still not perfect, and the main responsibility of drug launching license holders needs to be further consolidated. In order to meet the demand for clinical medication, to enhance the public’s sense of gaining access to the reform of the drug review and approval system and allow domestic patients to benefit from the high-quality & low-priced overseas-launched new drugs as early as possible, the following steps need to be done:

First, accelerate the examination and approval of clinically urgent drug reviews and implement relevant policies and measures issued by the SFDA to further encourage domestic launch of new overseas drugs;

Second, adjust the registration inspection process for imported chemical drugs, change the pre-launch registration inspection on all imported chemical drugs into post-launch supervision and sampling inspection, to accelerate the process of launching new overseas drugs;

Third, implement the data protection system. According to the clinical test situations of new overseas drugs in China, corresponding protection periods shall be given to the new overseas drugs, and the launch application for other drugs of the same kind shall not be approved within the protection period;

Fourth, implement drug patent linkage and patent term compensation systems to encourage innovators to have reasonable expected benefits and enhance the protection of intellectual property rights;

Fifth, comply with the decisions and deployments of the State Council;

Sixth, consolidate the building of a professional inspection team, tighten up the supervision during and after drug launch, increase overseas inspection, and allow international pharmaceutical innovations to benefit our domestic patients as early as possible.

(Chen Xinguang is a part-time researcher of Shanghai Academy.)