China issued the "Third Batch of Encouraged Generic Drugs Catalogue" to include 39 varieties

Chinanews.com, December 12 According to the website of the National Health Commission, in order to implement the "Opinions on Reforming and Improving the Supply Guarantee and Use Policy of Generic Drugs" of the General Office of the State Council and the "Notice on Printing and Distributing the Key Work Tasks for Deepening the Reform of the Medical and Health System in the Second Half of 27" 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 Administration, The State Food and Drug Administration and other departments organized experts to select and demonstrate the drugs whose domestic patents are about to expire and there is a shortage of clinical supply (insufficient competition), and formulated the "Third Batch of Encouraged Generic Drugs Catalogue".

It is reported that the third batch of catalogues includes 39 varieties, involving 75 specifications and 13 dosage forms, covering 12 aspects of treatment drugs such as antineoplastic drugs and immunomodulators, anti-infective drugs, nervous system drugs, radiodiagnostic agents, and cardiovascular system 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 therapeutic field and have a new mechanism of action. For example, patisran, a small interfering RNA drug for the treatment of adult hereditary transthyroxin-mediated amyloidosis, and vorcisporine, an oral drug for the treatment of adult active lupus nephritis in combination with immunosuppressants. The second is to improve access to medicines. Some of the drugs included in the third batch of catalogues, although drugs with the same mechanism of action have been marketed in China, due to the large clinical demand and the risk of supply shortage, 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 dosage forms included in the third batch of catalogues also include new pharmaceutical preparations such as sustained-release injections, dry suspensions, 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.

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 treatment 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 drug 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.

Previously, 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, 2 varieties in the catalogue have been approved for marketing, covering 33 therapeutic drugs such as anti-infective drugs, anti-tumor drugs, immunomodulators, and nervous system drugs, including 15 drugs for rare diseases.

Details of the Third Batch of Encouraged Generic Drugs are as follows:

The third batch of encouraged generic drugs list