1. National level
1. Recently, the State Pharmacopoeia Commission issued a notice on the release of the outline for the preparation of the "Chinese Pharmacopoeia" (2025 edition). The "Outline" points out that by 2025, the preparation of the new version of "Chinese Pharmacopoeia" will be fully completed. The standards of traditional Chinese medicines that conform to the characteristics of traditional Chinese medicine have been further improved. The standards of chemical drugs, biological products, pharmaceutical excipients and pharmaceutical packaging materials have reached or basically reached the international advanced level. The level of drug quality control and safety assurance has been significantly improved.
2. Recently, the General Affairs Department of the State Food and Drug Administration issued an announcement to publicly solicit opinions on the "Drug Standard Management Measures (Draft for Comments)". This measure has nine chapters and 46 articles. The deadline for public opinion solicitation is January 14, 2023.
3. Recently, the Central Committee of the Communist Party of China and the State Council issued the "Strategic Plan for Expanding Domestic Demand (2022-2035)", which includes five items related to medicine, including traditional Chinese medicine and vaccines, including the national immunization plan, biomedical industrialization development, drug supervision, and pharmaceutical imports.
4. Recently, the China Pharmaceutical Packaging Association publicly solicited opinions on the "Guidelines for the Appearance and Dimensions of Rubber Stoppers for Injection Packaging (Draft for Comment)". The deadline for feedback is: January 15, 2023. It was first published in 2011 as YBX2003-2011 "Appearance and Dimensions of Halogenated Butyl Rubber Stoppers for Injections"; this is the first revision.
5. Recently, the National Review Center issued three guiding principles, namely "Technical Guiding Principles for Clinical Efficacy Evaluation of New Traditional Chinese Medicines for Chronic Gastritis (Trial)", "Technical Guiding Principles for Clinical Efficacy Evaluation of New Traditional Chinese Medicines for Gastroesophageal Reflux Disease (Trial)" and "Guiding Principles for Natural History Research of Diseases in Rare Disease Drug Development". The first two will be implemented from the date of release, and the rare disease guidelines will be solicited for opinions for one month.
6. Recently, the State Food and Drug Administration issued the "Notice of the State Food and Drug Administration on the Online Operation of the Information Platform for Drug Non-clinical Safety Evaluation Research Institutions". The platform will be online from the date of release. GLP institutions should complete user registration and first information submission before January 31, 2023, and regulatory authorities should complete the review and confirmation of information before February 28, 2023.
7. Recently, the National Pharmacopoeia Commission issued 15 standard announcements for traditional Chinese medicinal excipients, involving varieties such as povidone K30, meglumine, triethanolamine , gum arabic , ethanol, rosin, etc., with the same publicity period of 3 months.
8. Recently, the State Pharmacopoeia Commission issued the "Guiding Principles for Powder Flowability Measurement", with a publicity period of three months from the date of release.
9. Recently, the State Food and Drug Administration issued a notice (No. 57, 2022) about 8 batches of drugs that did not meet the regulations, including 4 batches of unqualified decoction pieces: honeysuckle (content determination), peach kernel (characteristics, microscopic identification), Rubia (characteristics, microscopic identification).
2. Local level
1. Recently, the General Office of the Xinjiang Production and Construction Corps issued the "Xinjiang Production and Construction Corps' "14th Five-Year Plan" Traditional Chinese Medicine Development Plan." It is pointed out that by 2025, the health service capabilities of traditional Chinese medicine will be significantly enhanced, the revitalization and development of traditional Chinese medicine will achieve positive results, and its unique advantages in the construction of a health corps will gradually emerge.
2. Recently, 9 departments including the Hebei Provincial Administration of Traditional Chinese Medicine, the Hebei Provincial Health Commission, and Hebei Provincial Development and Reform Commission jointly issued the "14th Five-Year Plan Implementation Plan for the Hebei Province Grassroots Traditional Chinese Medicine Service Capacity Improvement Project", which clarified the six key tasks for Hebei Province to improve grassroots Chinese medicine service capabilities during the "14th Five-Year Plan" period, and proposed to In 2025, grassroots Chinese medicine should achieve five "full coverages", that is, government-run Chinese medicine medical institutions should basically achieve full coverage, community health service centers and township health center Chinese medicine halls should basically achieve full coverage, grassroots Chinese medicine service provision should basically achieve full coverage, grassroots Chinese medicine talent allocation should basically achieve full coverage, and grassroots Chinese medicine health education should achieve full coverage.
3. Recently, the Hebei Provincial Food and Drug Administration issued a public notice on the processing specifications (first batch) of traditional Chinese medicine pieces in Hebei Province. The public notice period is 15 days.Involving 53 varieties: moxa rong, moxa leaf charcoal, white lentils clothes, white lotus seeds , grass fruit , fried mugwort leaves, fried grass nuts, fried winter melon seeds, fried lotus seeds, fried puhuang, fried Chinese gallnut , tangerine peel charcoal, vinegar turmeric, large sapodilla root, rehmannia glutinosa charcoal, earthworm root (wine roasted), cardamom bark, eucommia ulmoides charcoal, French water pinellia, parsnip charcoal, Fenfen wood, bran fried Chuanxiong , floating sea stone, floating wheat, wolfberry leaf, black fruit wolfberry, astragalus Bark bark, astragalus charcoal, ginger water pinellia , Ligusticum chuanxiong, wine Schisandra chinensis, tangerine network, lotus root , mung bean clothing, myrrh, honey polygala, stir-fried Sophora japonica, water pinellia, amaranth seed, cinnamon , frankincense , Amomum villosum (seed balls), hawthorn core, hawthorn charcoal, verdigris, fried Atractylodes , woodworm (roasted in wine), marigold, simmered kudzu root, centipede (strips), fresh bamboo fish fat, black plum, etc.
4. Recently, Fujian Provincial Health Commission, Provincial Development and Reform Commission, Provincial Department of Education and other 8 departments jointly issued the "14th Five-Year Plan for the Improvement Project of Grassroots Traditional Chinese Medicine Service Capacity in Fujian Province", which proposed that by 2025, grassroots Chinese medicine will achieve five "full coverage", namely " County-run TCM medical institutions (hospitals, outpatient departments, clinics) have basically achieved full coverage, community health service centers and township health center TCM clinics have basically achieved full coverage, grass-roots TCM service provision has basically achieved full coverage, grass-roots TCM talent allocation has basically achieved full coverage, and grass-roots TCM health education has achieved full coverage", achieving "common diseases are solved in cities and counties, and daily diseases are solved at the grassroots level."
5. Recently, the Fujian Provincial Food and Drug Administration issued a notice on the issuance of the "Implementation Rules of the Fujian Provincial Medical Institutions Preparation Registration Management Measures". These rules include seven chapters and 55 articles, which will be effective from the date of issuance and will be valid for 5 years.
6. Recently, the Shandong Provincial Food and Drug Administration issued a notice on amending and continuing to implement the "Shandong Provincial Regulations on the Supervision and Administration of the Resumption of Production of Long-term Suspended Drug Production Units". These regulations, which contain ten articles, will be effective from January 1, 2023, and will be valid until December 31, 2027.
7. Recently, the Shanxi Food and Drug Administration issued the "Measures for the Supervision and Inspection of the Production of Selected Drugs in Centralized Volume Procurement", which requires the inspection of marketing authorization holders of the selected drugs from the previous quarter to be completed at the end of each quarter, focusing on the selected drugs at low prices or significantly reduced prices, and closely focusing on risk factors such as prescription processes and production changes. The inspections will be implemented from the date of issuance.
8. Recently, the Chongqing Municipal Food and Drug Administration issued 10 measures to help enterprises to fully support the resumption of production and market of "two products and one device" companies, including 4 related to pharmaceutical companies.
9. Recently, the Sichuan Provincial Food and Drug Administration announced the Sichuan provincial label for traditional Chinese medicine formula granules (the tenth batch). The publicity period is 10 days, involving 16 varieties: Beiliu Jinu , fried rice sprouts, agarwood , soybean yellow rolls , rhubarb charcoal ( Medicinal rhubarb ), Pteris , braised nutmeg, burnt rice sprouts, alum, gentian, aloe vera (Aloe vera), plum blossom, heather leaf, simmered pink kudzu , bamboo leaf Bupleurum (bamboo leaf Bupleurum), Lithospermum (Xinjiang Lithospermum), etc.
10. Recently, the Inner Mongolia Food and Drug Administration announced the standards for traditional Chinese medicine formula granules (second batch) in the Inner Mongolia Autonomous Region. The publicity period is 7 days, involving 46 varieties: moxa leaf, white and , Baiziren . Fried grain buds , fried silkworms, fried cassia seeds (Cassia obtusa), agarwood, Semen silivia , Pangolin , vinegar and frankincense, big belly skin, light tempeh, Sandiyu charcoal (diyu), cloves, etc.
Pay attention to the public: Gao Peng talks about herbal medicines and learn more about the market and industry trends of Chinese herbal medicines.
