Food and Drug Administration gives priority to the approval of imported drugs for rare diseases.

　　Guangzhou Daily News (all-media reporter Tu Duanyu) Imported drugs are "galloping" into the China market, and the fastest one only needs to wait for a few more months. A few days ago, Yang Zhimin, director of the Clinical Department of Chemical Medicine of National Medical Products Administration Drug Evaluation Center, revealed in an interview with CCTV that drugs that have been proved to be effective for advanced tumors will be included in the priority review. From the current situation, the priority review time can be shortened to 4-6 months for approval. In the face of the influx of imported drugs, domestic generic drugs will take the "cost-effective" route to meet the challenge.

　　New drugs are expected to enter the China market within six months.

　　CCTV reported that China has accelerated the review and approval of drugs for major diseases, such as malignant tumors, drugs for children, drugs for frequently-occurring diseases in the elderly, drugs for rare diseases, and drugs in clinical shortage, by introducing measures such as giving priority to review and approval and optimizing procedures for drugs with obvious clinical advantages. It is understood that National Medical Products Administration has started to organize experts to study and classify 201 new drugs under review and approval and 138 new drugs that have not been declared in China, totaling 339 new drugs, and to screen out drugs for rare diseases and drugs with serious life-threatening clinical needs (including anticancer drugs). For these drugs, if the applicant thinks that there is no racial difference, he can submit all overseas research materials, ethnic difference research materials and post-marketing research materials obtained in other countries and directly declare them for listing. For the above drugs, National Medical Products Administration will concentrate on the evaluation and speed up the evaluation.

　　It is reported that seven new drugs for preventing and treating serious life-threatening diseases, such as nine-valent cervical cancer vaccine, have recently been listed in China, and other international first-line drugs are expected to enter the China market within six months at the earliest.

　　Not long ago, Jiao Hong, director of National Medical Products Administration, also stated that the speed of listing of imported drugs would be accelerated. According to its introduction, in the past ten years, there were 415 new drugs listed in the United States, the European Union and Japan, of which 76 were listed in China, and 201 were in the stage of clinical trials and (listing) declaration in China.

　　In fact, at the end of last year, the former State Food and Drug Administration issued a new version of the Opinions on Encouraging Drug Innovation to Implement Priority Review and Approval, further delineating the scope of the "green channel" for drugs. The opinion pointed out that all applications for drug registration with obvious clinical advantages for the prevention and treatment of AIDS, viral hepatitis, rare diseases, malignant tumors and children’s diseases can enter the "green channel" for priority review, and seven applications for drug registration with obvious clinical value can also get the qualification for review first, including the use of advanced preparation technology, innovative treatment methods and drug registration applications with obvious therapeutic advantages.

　　China’s generic drug evaluation and approval accelerated.

　　At the same time, we must strictly control the speed.

　　The opinion requires that the drug testing center should establish a meeting communication mechanism and online consultation platform with the applicant for the application for registration of new drugs with priority review and approval, and will give priority to the verification of the authenticity of drug clinical trial data. Once the application materials are falsified, the applicant will be deprived of the qualification to submit applications for priority review of other varieties within 3 years.

　　Seeing a large number of imported drugs "Enemy at the Gates", how to deal with domestic drugs?

　　At present, National Medical Products Administration is encouraging domestic drugs to pass the consistency evaluation of generic drugs’ quality and efficacy, so as to partially replace imported drugs in clinic and reduce the burden of medical insurance and the economic pressure of patients through the route of "high cost performance".

　　It is understood that the consistency evaluation and approval of generic drugs in China has also entered an accelerated period. Just at the end of last month, National Medical Products Administration announced the fifth batch of 16 drug specifications that passed the consistency evaluation of generic drugs’ quality and efficacy. So far, 57 drug specifications have passed the consistency evaluation of generic drugs. Since May this year, the number of consistency evaluation drugs accepted every month has tripled.

　　In order to respond to the State Council’s opinion that "medical institutions should give priority to purchasing and using drugs that have passed the consistency evaluation", more and more provinces began to introduce incentive policies and take special procurement measures for varieties that have passed the consistency evaluation.

　　An industry observer said that China pushed generic drugs and original drugs to pass the consistency evaluation in quality and efficacy, and supported domestic high-quality generic drugs from medical insurance, taxation, procurement and other aspects in a "multi-pronged" way, encouraging pharmaceutical companies to dare to compete for the market share of original drugs, so as to realize "a hundred flowers blossom" in the market — — Both imported new drugs and "cost-effective" generic drugs are available.