"Life saving medicine" is coming quickly! Shanghai to explore the import of new antitumor drugs for clinical trials

Source: surging News May 25, 2018 in Shanghai, advanced cancer patients are in urgent need of clinical drugs, which is expected to accelerate the import of clinical trials free through regular channels On May 23, the State Food and Drug Administration and the state health and Health Commission issued relevant announcements, saying that for the drugs that have been listed abroad to prevent and control diseases that are seriously life-threatening and have no effective treatment means, if there is no ethnic difference through research, they can submit the clinical trial data obtained abroad and directly apply for drug listing registration On May 24, surging news (www.thepaper CN) learned from Shanghai food and drug administration that Shanghai has formed a pilot work plan for using foreign listed anti-tumor drugs in designated medical institutions and a series of risk control measures Recently, this pilot program will be submitted to relevant national departments The approval flow chart of drug-free clinical trial is urgently needed for advanced tumor patients This is a picture from Shanghai Research Institute Some people have ventured to get drugs through "black channel" for a long time According to the interview of surging news reporters, anti-tumor new drugs that have been listed abroad must be approved by the national drug regulatory authorities in order to be listed in China This process includes multiple links of review and approval, which generally takes three to five years However, for a long time, there have been some shortcomings in the design of drug review and approval system in China, such as slow approval speed, a large number of applications backlog, and different ethnic groups Previously, the data of foreign clinical trials were not recognized at all Even if foreign drugs have been put on the market, they need to conduct clinical trials again in China, repeat experiments, so as to prolong the application time According to the industry, some typical foreign new drugs listed in China in the past 10 years have been on the market 5 to 7 years later than those in Europe and America on average, some of which are out of date as soon as they are on the market At the same time, due to factors such as intellectual property protection and market strategy, foreign pharmaceutical companies will not list some new drugs in China in a short period of time, which leads to fewer types of new drugs listed in China But the patient can't wait For the latest anti-tumor drugs abroad, those with strong economic strength and related channels will go to foreign countries for medical treatment directly; those with affordable economic conditions but little knowledge of how to get medical treatment abroad and no relationship will go to foreign countries for treatment through intermediary The vast majority of patients lack the economic strength to go abroad for treatment, so they are willing to take risks, through all kinds of shopping websites, social networking sites and friend circles and so on This has become the main "black channel" for foreign drugs to enter China According to the relevant laws and regulations, these imported drugs that are not listed in the domestic market shall be treated as fake drugs, and hospitals and doctors are not allowed to use them for clinical treatment Due to the lack of effective supervision, there are many fake drugs, some even fake foreign new drugs produced in China, which cause great economic losses and life risks to patients It is possible that Shanghai food and drug administration has carried out in-depth research on this issue Due to the division of powers, the matter involves drug supervision, health, customs, hospitals and other departments, which requires the joint efforts of all parties On the basis of preliminary research, Shanghai food and drug administration has formed a pilot work plan and a series of risk control measures for designated medical institutions in Shanghai to use foreign listed new anti-tumor drugs in advance, and has successively gone to the municipal health and Family Planning Commission, Renji Hospital, Shanghai Pharmaceutical Group and other relevant units to carry out in-depth thematic research and listen to suggestions and opinions from all parties In the investigation, Shanghai food and Drug Administration found that there are still several problems in the current scheme: how to price such drugs when they are not listed in China? Who is responsible for the purchase, transportation and storage of drugs? Who should apply for imported drugs? After repeated research and discussion by multiple departments, it is clear that medical institutions are the main applicants, Shanghai food and drug administration, together with the municipal health and Family Planning Commission, and factors such as the level of comprehensive hospital, medical service, quality management level and clinical experience, designates comprehensive hospitals with tumor specialty and departments ranking at the forefront of the country as designated pilot units Shanghai Health and Family Planning Commission, together with Shanghai food and drug administration, has drawn up a specific catalogue of varieties, which has been approved by drug regulatory agencies in the United States, the European Union, Japan and other regions for marketing in designated medical institutions However, there is no foreign new anti-tumor drug with the same variety of products approved for registration in China, which is used for advanced cancer patients without more treatment options under the existing diagnosis and treatment specifications Zhang Qing, director of the drug registration office of Shanghai food and drug administration, said that the focus of the Shanghai pilot program is, on the one hand, to shorten the licensing process as much as possible On the other hand, some special cases, such as critical patients who are in urgent need of clinical treatment and have no means of treatment, can be exempted from clinical trials, directly apply for drug registration, and use imported new drugs through regular channels According to Chen Yaoshui, deputy director of Shanghai food and drug administration, the pilot scheme is proposed to be put forward by doctors who know adverse reactions and risk points in designated hospitals and departments After the formulation of the medication plan and the approval of the ethics committee, an application is made After the examination and approval of the administrative department of health, the goods shall be imported through the green channel of the customs At present, the pilot scheme has been prepared and submitted to the relevant administrative departments of the state for approval.