The State Council issued a heavy document to strongly support the development of these five categories of pharmaceutical enterprises

On March 10, the official website of The State Council published the Guidance Catalogue for Industrial Structure Adjustment (2024 edition). The new catalog was reviewed and adopted at the 6th Committee meeting on December 1, 2023, and came into effect on February 1, 2024, and the "Industrial Structure Adjustment Guidance Catalog (2019 version)" was repealed at the same time.

The new edition of the Industry Catalog in 2024 consists of three categories: encouraging category, restricting category and eliminating category. Among them, the pharmaceutical industry involves 5 encouraged categories, 6 restricted categories and 13 eliminated categories. Details are as follows:

1. Encouragement

1. Pharmaceutical core technology breakthrough and application: Membrane separation, new crystallization, chiral synthesis, enzymatic synthesis, continuous reaction and other apis advanced manufacturing and green low-carbon technology, new drug preparation technology, new biological drug delivery and delivery technology, large-scale efficient cell culture and purification, pharmaceutical peptide and nucleic acid synthesis technology, antibody coupling, carrier virus preparation and other technologies, the use of modern biotechnology transformation and upgrading.

2. New drug development and industrialization: innovative and improved new drugs with independent intellectual property rights, children's drugs, shortage drugs, rare disease drugs, major disease prevention and control vaccines, new antibody drugs, recombinant protein drugs, nucleic acid drugs, biological enzyme preparations, gene therapy and cell therapy drugs.

3. Biomedical supporting industry: development and production of chemical-defined cell media, new purification fillers and filter membrane materials, high-end pharmaceutical excipients, development and production of new pharmaceutical packaging materials and technologies such as new pharmaceutical adjuvants for vaccines, special functional materials, and development and production of new packaging systems and drug delivery devices such as mixed-use and intelligent packaging; High-end, intelligent pharmaceutical equipment, new preparation production equipment, large-scale bioreactor and auxiliary system, protein efficient separation and purification equipment, drug continuous production equipment; Standard animal breeding and animal testing services.

4. High-end medical device innovation and development: New gene, protein and cell diagnostic equipment, new medical diagnostic equipment and reagents, high-performance medical imaging equipment, high-end radiation therapy equipment, emergency and critical life support equipment, artificial intelligence assisted medical equipment, mobile and remote diagnosis and treatment equipment, high-end rehabilitation AIDS, high-end implant interventional products, surgical robots and other high-end surgical equipment and consumables, Development and application of biomedical materials and additive manufacturing technology.

5. Traditional Chinese medicine inheritance and innovation: traditional Chinese medicine identification technology inheritance and innovation, traditional Chinese medicine preparation technology inheritance and innovation, traditional Chinese medicine innovation and improved new drugs, ancient classic prescription compound preparations, national medicine development and production, efficient extraction of traditional Chinese medicine, whole process quality control and information tracing and other new technologies and new equipment development and application.

2. Restrictions

1. Build or expand the production equipment for the raw powder of koronic acid and vitamin C (including medicinal, food, feed and cosmetics), and build the production equipment for the raw materials of vitamin B1, vitamin B2, vitamin B12 and vitamin E for the purposes of medicine, food, feed and cosmetics.

2. Penicillin industrial salt, 6-amino-penicillanic acid (6-APA), 7-amino-cefanoic acid (7-ACA), 7-amino-3-deacetoxy-cefanoic acid (7-ADCA), Penicillin V, ampicillin, hydroxypicillin, cephalosporin C, oxytetracycline, chloramphenicol, acetaminophen, paracetamol, Lincomycin, gentamicin, dihydrostreptomycin, amikacin, medemycin, alcomycin, ciprofloxacin, floxacin, rifampicin, caffeine, coxacin production equipment.

3. Production equipment of paclitaxel (except supporting taxus chinensis planting) and berberine (except supporting Coptis chinensis planting).

4. New, reconstruction and expansion of medicinal butyl rubber plug, two-step production of infusion plastic bottle production equipment.

5. Build, upgrade and expand the production equipment of products with raw materials containing endangered animals and plants that have not yet been cultivated or cultured on a large scale.

6. Build, rebuild and expand mercury-filled glass thermometer, sphygmomanometer production equipment, silver amalgam dental materials, and build 200 million disposable syringes, blood transfusion devices and infusion devices less than/year.

3. Elimination items

(1) Backward production technology and equipment

1. Manual capsule filling process. 2. Cork hot wax packaging drug technology. 3. Tower type redistiller. 4. Hot air drying oven without purification facilities. 5. Production equipment for raw materials whose environment, occupational health and safety cannot meet national standards. 6. Iron powder reduction method acetaminophen (paracetamol), caffeine device. 7. Processes for the production of medical supplies using chlorofluorocarbons (CFCs) as aerosols, propellants, ejectors or dispersants (phased out in accordance with the requirements of the national master plan for the implementation of international conventions). 8. Mercury-filled glass thermometer and sphygmomanometer production plant (December 31, 2025).

(2) Backward products

1. Lead tin ointment tube and single-layer polyolefin ointment tube (except anorectal and endovascular administration). 2. Sterile powder for ampoule filling and injection. 3. Medicinal natural rubber plug. 4. Non-collapsible ampoules. 5. Polyvinyl chloride (PVC) soft bag for infusion (excluding peritoneal dialysis solution and flushing solution).

   
   

(Excerpt from "New Kang Jie")