Recently, the General Office of the National Health Commission, together with the General Department of the State Food and Drug Administration and other relevant departments, issued the "Notice on Printing and Distributing the Third Batch of Encouraged Generic Drug Catalog".
According to the notice, in order to implement the "Opinions on Reforming and Improving the Policy on the Protection and Use of Generic Drugs" of the General Office and the "Notice on Printing and Distributing the Key Tasks for Deepening the Reform of the Medical and Health System in the Second Half of 2023" issued by the National Health Commission and other 6 departments on the deployment and requirements of the list of encouraged generic drugs, the National Health Commission, the Ministry of Industry and Information Technology, the State Intellectual Property Office, the National Health Insurance Administration, the National Disease Control and Prevention Bureau, the State Food and Drug Administration and other departments organized experts to review the upcoming expiration of domestic patents and clinical ** Drugs in short supply (insufficient competition) were selected and demonstrated, and the "Third Batch of Encouraged Generic Drugs List" was formulated.
Appendix: The third batch of encouraged generic drugs.
Notice on Printing and Distributing the Third Batch of Encouraged Generic Drugs Catalogue" Policy Interpretation.
1. Main features of the Third Batch of Encouraged Generic Drugs Catalogue.
Generic drugs are an important part of the drug security system. In order to further improve China's drug guarantee capacity and better meet the people's demand for high-quality generic drugs, the National Health Commission, together with the Ministry of Industry and Information Technology, the State Intellectual Property Office, the National Health Insurance Administration, the National Disease Control and Prevention Administration, the State Food and Drug Administration and other departments, organized experts to sort out the selection and demonstration of domestic drug patents and clinical shortage (insufficient competition) of drugs. Factors such as the difficulty of process development and the domestic research situation, the third batch of encouraged generic drugs catalogue (hereinafter referred to as the third batch of catalogues) shall be drafted and issued and implemented according to the procedures after soliciting opinions from the public. The third batch of catalogues includes 39 varieties, involving 75 specifications and 13 dosage forms, covering 12 aspects of drugs such as antineoplastic drugs and immunomodulators, anti-infective drugs, nervous system drugs, radiodiagnostic agents, and cardiovascular system drugs.
The third batch of catalogues has three main characteristics: First, it covers a wide range of disease areas. The drugs included in the third batch of catalogues are produced by the selection and demonstration of multi-departmental and multidisciplinary experts organized by our committee, and take various forms such as drug information combing, professional subject consultation, dosage form specifications discussion one by one and independent voting by experts, and fully listen to expert opinions in clinical, pharmaceutical, public health, drug evaluation, intellectual property rights, etc., and include drugs such as anti-tumor, infectious disease ** and radiodiagnostic drugs, and child-friendly dosage forms such as suspensions. The second is to pay attention to the coordination with the reference preparation filing information. In the selection of dosage form specifications, the third batch of catalogue drugs should carefully refer to the catalogue of generic reference preparations issued by the State Drug Administration, and most of the drugs included are varieties with existing reference preparations, so as to improve the efficiency of enterprise imitation. The third is to take into account the enthusiasm of enterprise research and development. In the process of selecting the third batch of catalogs, the clinical application prospects, production process difficulties and potential market space of drugs were comprehensively evaluated through data analysis and expert demonstration, so as to improve the feasibility of enterprise imitation.
2. The clinical drug needs met by the "Third Batch of Encouraged Generic Drugs".
The third batch of catalogues is guided by the needs of clinical drugs, enriching the selection of clinical drugs and improving the quality of clinical drugs. The first is to fill the gap in clinical medication in China. Many of the drugs included in the third batch of catalogues are overseas marketed and domestic unmarketed varieties, which are the world's first drugs in this field and have a new mechanism of action. For example, the small interfering RNA drug patistran of polyneuropathy mediated by hereditary transthyroxine mediated amyloidosis, and the oral drug vorcyclosporine for active lupus nephritis combined with immunosuppressants. The second is to improve access to medicines. Some of the drugs included in the third batch of catalogs, although drugs with the same mechanism of action have been marketed in China, due to the large clinical demand, there is a risk of shortage, so they are also included in the scope of encouraging imitation to meet the accessibility of clinical drugs. The third is to encourage innovative preparation technology. In addition to traditional tablets and capsules, the pharmaceutical dosage forms included in the third batch of catalogues also include new pharmaceutical preparations such as sustained-release injections, dry suspensions, and sublingual tablets, as well as child-friendly dosage forms and new compound preparations, so as to better meet the drug needs of different patients and improve patient suitability. Fourth, improve the accuracy of clinical diagnosis. The third batch of catalogues includes 6 radiopharmaceuticals, which can be used for imaging diagnosis and positioning, all of which are unmarketed drugs in China, which are of great significance for the timely diagnosis of diseases and the course of diseases.
3. The main considerations for encouraging the selection of generic drug lists.
Encourage the selection of generic drug lists, taking into account the necessity of clinical drugs and the feasibility of enterprise research and development. The first is to adhere to the clinical demand-oriented. Fully consider the basic national conditions at this stage and in the future, highlight the clinical value orientation, based on the information of generic drugs that have been marketed overseas and not listed in China in recent years, sort out the information on drug indications, advanced fields, and recommendations for major clinical drug guidelines for related diseases to further match clinical needs, and then sort out the domestic relevant drug patent situation, focusing on clinically necessary drugs with definite efficacy, including drugs required for the prevention and treatment of major infectious diseases and rare diseases. The second is to take into account the feasibility of enterprise research and development. Our committee and relevant departments set up a selection working group, organized experts to jointly study and demonstrate, and comprehensively considered factors such as the current status of domestic drug research and development, the difficulty of production process, the first grade of APIs, the risk of patent infringement, and the catalog of reference preparations.
Fourth, the implementation of the first two batches of the "Catalogue of Encouraged Generic Drugs".
The National Health Commission and relevant departments have successively issued two batches of the "Catalogue of Encouraged Generic Drugs", which has played an effective role in encouraging and guiding the R&D and listing of drugs in the catalogue. At present, 33 varieties in the catalogue have been approved for marketing, covering 15 aspects of drugs such as anti-infective drugs, anti-tumor drugs, immunomodulators, and nervous system drugs, including 7 drugs for rare diseases. The main results are as follows:
The first is to guide the R&D of enterprises in an orderly manner to ensure the accessibility of drugs. Many of the drugs that have been marketed in the first two batches of the catalogue have been approved for marketing in China for the first time after the catalogue was released. For example, there are domestic drugs such as treprostinil injection that have been approved for the first time, imported drugs such as glatiramer injection that have been approved for the first time, and domestic and imported drugs such as etibant injection that have been approved for marketing.
The drugs approved for marketing for the first time include a number of drugs for rare diseases, such as nitisinone capsules for hereditary tyrosinemia type **;At the same time, it is also involved in the fields of respiratory system drugs, endocrine and metabolic drugs, anti-infective drugs and other commonly used drugs, such as ** and posaconazole injection for the prevention of invasive aspergillosis.
The second is to guide the formation of full market competition and ensure the best drugs. Among the 33 varieties that have been listed in the first two batches of catalogs, 15 varieties are produced by 3 or more enterprises, 6 varieties are produced by 2 enterprises, and 12 varieties are produced by 1 enterprise;There were already marketed drugs before the release of the catalog, and there were 9 varieties of new manufacturers after the release. The release of the catalogue has improved the current situation that there are no drugs available for some clinical diseases, enriched the selection of drugs in common fields, and effectively guaranteed clinical drugs.
The third is to connect with the drug regulatory policy to promote the rapid listing of drugs that are urgently needed in clinical practice. In order to speed up the listing of clinically urgently needed drugs with outstanding clinical value, the generic drug catalogue is encouraged to adhere to the clinical demand orientation, connect with the drug regulatory policy, promote the R&D declaration of the catalogue drugs, stimulate the R&D and production momentum of enterprises, and promote the R&D of generic drugs. In the first two batches of the catalog, 14 drugs have been approved for marketing authorization through the priority review and approval process.
Fourth, it is connected with medical insurance policies to improve the accessibility of drugs. Drugs in the generic drug catalogue are encouraged to be declared and included in the national medical insurance catalogue on a priority basis according to the procedures. In the first two batches of the catalogue, 12 varieties have been negotiated into the national medical insurance catalogue. Including a variety of drugs for rare diseases, **thalassemia and breast cancer and other major diseases, reduce the drug burden of patients and improve the accessibility of clinical drugs.
5. Supporting policies related to the catalogue of generic drugs are encouraged.
In order to ensure the smooth implementation of the catalogue of encouraged generic drugs, the National Health Commission, together with the Ministry of Industry and Information Technology, the State Intellectual Property Office, the National Health Insurance Administration, the National Disease Control and Prevention Administration, the State Food and Drug Administration and other departments, has established a cross-departmental information sharing, communication and consultation and collaborative innovation mechanism, and promoted the convergence and coordination of supporting policies such as encouraging the research and development, registration, production, use, and reimbursement of generic drugs.
According to the needs of the work, our committee will organize relevant units, industry associations, and willing market entities in a timely manner to strengthen multi-party policy communication, technical consultation and work coordination, and better support and guide enterprises to develop high-quality generic drugs for clinical needs.