1. New drugs obtained from animals, plants, microorganisms, chemical synthesis or semi-synthesis and biotechnology that meet the following conditions:
(1) The chemical structure of the drug is unprecedented;
(2) Pharmacology, toxicology and clinical tests prove that it is safe and reliable, and its curative effect is better than that of known similar drugs;
(3) If it has been trial-produced or formally produced, it shall have the approval number of the health department or the new drug certificate.
2. Known drugs or compounds have found new non-traditional therapeutic uses. Pharmacology, toxicology and clinical trials have proved that its clinical efficacy, side effects or other aspects are obviously superior to the existing similar drugs, and it is widely used in clinic.
3. Derivatives obtained by non-obvious methods, if they are new compounds, have been proved to be safe and reliable by pharmacological, toxicological and clinical tests, and have remarkable curative effects, which have overcome the serious shortcomings of the original drug, and can be declared as invention prizes. However, the curative effects of derivatives or degradation products of well-known drugs are still within the characteristics of the original drug, and those who have certain advantages but are not outstanding cannot be declared as invention prizes.
4. It has an original new dosage form, including a new guiding carrier, a new synergist, a new drug-decomposing enzyme inhibitor, a new stabilizer, a new sustained-release agent or an important auxiliary material, so that the drugs are directionally distributed in the body; Pharmacokinetic properties were obviously improved; The bioavailability is obviously improved, the toxic and side effects are obviously reduced, and the curative effect or validity period is obviously prolonged. It is proved to be safe and reliable by pharmacological and clinical tests, and has been produced and has clinical application value. Second, Chinese herbal medicines and Chinese patent medicines.
1. New techniques and methods for cultivating Chinese medicinal materials, including improved seed cultivation, biotechnology and new techniques for protecting medicinal plants, have been applied in the production of Chinese medicinal materials, ensuring product quality and achieving remarkable economic benefits.
2. The new processing technology of difficult medicinal materials has achieved remarkable results in quality, curative effect and comprehensive technical indicators, and has been applied to production, which has practical application value.
3 after technical processing, put forward the physical and chemical quality standards, and proved by pharmacology, toxicology and clinic to be safe and reliable, and the therapeutic effect is obvious.
4. The new substitute Chinese medicinal materials of precious and rare medicinal materials have been proved to be safe and reliable by pharmacological, toxicological and clinical tests, and the curative effect is the same as that of the old medicinal materials, and the quality standard has been established.
5. The efficacy, toxicity and medicinal properties of the known traditional Chinese medicine prescriptions were deeply studied, and the original new traditional Chinese medicine prescriptions with very significant curative effect on serious diseases were obtained, but the increase or decrease of the general medicinal taste was not an invention.
6. A new patent medicine that has been analyzed, identified, separated and extracted by folk prescription, prescription and applied chemical methods, and proved to be safe and reliable by pharmacological, toxicological and clinical tests, and has remarkable curative effect. Third, nervous.
1. New strains with medicinal value refer to: (1) new substances or known drugs which have been proved safe and reliable by management methods, pharmacology, toxicology, pharmacokinetics and clinical tests, and have been produced and applied in clinic with remarkable curative effect; (2) It has important uses in pharmaceutical industry or drug detection and has been actually applied.
2. The strains discovered by self-excavation have never been published at home and abroad, or recorded in microbial taxonomy, but only their general morphological, physiological and biochemical characteristics have been clarified, but their medicinal value has not been clarified; Or strains with important medicinal value obtained by biotechnology such as genetic engineering and cell engineering.
3. A new strain discovered for the first time in China. Compared with the existing similar (or similar) drugs at home and abroad, the drugs made from this strain have unique or similar curative effects, but the toxic and side effects are obviously reduced, or they have special therapeutic effects on difficult diseases. It has been applied in production and has clinical application value. Four, biological products and biochemical drugs
1. A new biological product used for prevention, diagnosis and treatment has been clinically proved to be effective for prevention or treatment, or can obviously improve the diagnosis rate.
2. Any new biochemical substance extracted and separated from biological resources has obvious curative effect after clinical application.
3. The structure of biochemical drugs from animals has been transformed into a new biochemical drugs with the same structure as similar biochemical substances in human body, and it has been produced and applied in clinic. Five, medical devices, medical devices and sanitary equipment
1. An unprecedented new medical instrument and equipment designed and manufactured by ourselves has achieved remarkable results after production and clinical use.
2. The existing medical instruments and equipment have been creatively improved in principle, method or key parts, and have certain adaptability in diagnosis, treatment, rehabilitation, health care and family planning. , and the sensitivity, repeatability, resolution or clinical effect of the instrument are unique, superior to the most advanced similar products, and have achieved remarkable results through clinical use. Six, medical materials and products
1. An unprecedented new medical material or product synthesized, designed and manufactured by itself at home and abroad. After production verification, it has specific clinical uses and indications, and the effect is remarkable.
2. Sanitary materials with significant health benefits have been proved to be beneficial and harmless to human body. Seven, new technology
The process route independently designed in the fields of medicine, biochemical drugs, biological products and medical devices has been creatively improved in key reactions, formulas, methods, processes or detection technologies, and it has been proved by production that it has remarkable effects on ensuring product quality and improving social or economic benefits.