According to the definition of drugs in Article 12 of the Drug Administration Law of the People's Republic of China, drugs refer to substances that are used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions, and specify indications or functional indications, usage and dosage, including Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum and dosage. In January 213, the National Development and Reform Commission issued a notice, and decided to adjust the maximum retail price limit of drugs such as respiratory, antipyretic and analgesic drugs and special drugs for specialties from February 1, 213. * * * involves 2 kinds of drugs, more than 4 varieties and more than 7 representative dosage forms, with an average price reduction of 15%, of which the average price reduction of high-priced drugs reaches 2%.
Chinese name
drugs
mbth
medicien
according to
the Drug Administration Law of the People's Republic of China
functions
to prevent, treat and diagnose human diseases
including
Chinese herbal medicines, Chinese herbal pieces and Chinese patent medicines
varieties. Regulate people's physiological function purposefully, and have specified indications, usage and dosage requirements of < P >; From the way of use: patients can't identify their internal quality except the appearance, and many drugs need to be used under the guidance of doctors, not decided by patients' choice. At the same time, the use method, quantity, time and other factors determine the use effect to a great extent. Misuse can not only "cure", but also "cause disease" and even endanger life safety. Therefore, medicine is a special commodity.
1. Variety complexity: There are about 2, kinds of specific varieties in the world, about 5, kinds of traditional Chinese medicine preparations and about 4, kinds of western medicine preparations in China, which shows that the types of drugs are complex and varied.
2. Medical specificity of medicine: medicine is not an independent commodity, it is closely combined with medicine and complements each other. Only through the examination and diagnosis of doctors and the rational use of drugs under the guidance of doctors can patients achieve the purpose of preventing diseases and protecting health.
3. Strict quality of drugs: drugs are directly related to people's health and even life and death, so their quality should not be sloppy. We must ensure the safety, effectiveness, uniformity and stability of drugs.
in addition, the quality of drugs has obvious characteristics: unlike other commodities, there are quality grades: superior products, first-class products, second-class products, qualified products, etc., all of which can be sold, while drugs can only be sold if they meet the requirements or not.
2 Management Specification Editor
Compliance of drug quality means not only that the product quality conforms to the registered quality standards, but also that the whole process should conform to the good manufacturing practice (GMP).
Good Manufacture Practice (GMP) is the basic principle of pharmaceutical production and quality management, which is applicable to the whole process of pharmaceutical preparation production and the key working procedures that affect the quality of finished products in the production of raw materials. Vigorously promoting drug GMP is to avoid pollution and cross-contamination in the process of drug production to the maximum extent, reduce the occurrence of various errors, and is an important measure to improve drug quality.
3 Price Reduction Editor
At the beginning of January 213, the National Development and Reform Commission issued a notice, and decided to adjust the maximum retail price limit of drugs such as respiratory, antipyretic and analgesic drugs and special drugs for specialties from February 1, 213. * * * involves 2 kinds of drugs, more than 4 varieties and more than 7 representative dosage forms, with an average price reduction of 15%, of which the average price reduction of high-priced drugs reaches 2%. [1]
The average price of the earliest medical insurance varieties was reduced by 4%
According to the relevant person in charge of the Price Department of the National Development and Reform Commission, the Development and Reform Commission implements a dynamic price adjustment mechanism for drugs (mainly drugs in the medical insurance catalogue) that are included in the government's pricing range, based on factors such as drug costs and market price changes, generally once every 2-3 years. Since 21, the National Development and Reform Commission has successively issued three rounds of drug price adjustment schemes, involving nearly 2, kinds of drugs. For the first varieties to enter the medical insurance catalogue, the cumulative price reduction has reached an average of 4%, and the highest has reached 8%; The latest varieties to enter the medical insurance catalogue have just begun to reduce their prices, with an average of about 15%. [1]
In the first round of adjustment from 21 to 23, the government-managed drugs were comprehensively adjusted for the first time. [1]
In the second round of adjustment from 26 to 27, combined with the varieties of medical insurance catalogue, the government-managed drugs were comprehensively adjusted again. [1]
From 211 to 212, the National Development and Reform Commission made a comprehensive adjustment to the chemicals at government management prices. [1]
since 211, eight kinds of drugs, such as antibiotics, circulation, nerves, hormones, digestion, anti-tumor, immunity and blood, have been adjusted in four batches, which belong to the same round of price adjustment varieties, and most of them belong to common clinical drugs. So far, the NDRC has basically completed the price adjustment of chemicals, and will start the price adjustment of proprietary Chinese medicines from 213. [1]
appropriately increase the price of low-priced drugs in clinical shortage
According to the tracking and investigation of the previous drug price adjustment by the relevant departments of the National Development and Reform Commission, the drug price adjustment has obvious effect on reducing the burden of patients who use drugs all the year round. The latest round of drug price reduction can reduce the burden on patients by more than 6 billion yuan every year. In this round of price adjustment, the average decline of high-priced drugs reached 2%. For example, for the treatment of Alzheimer's disease (Alzheimer's disease), 1.5 mg× 28 capsules (produced by Novartis, trade name "Esneron") cost 32.6 yuan the day before the price reduction and 19.8 yuan the day after the price reduction, with a decrease of 39%. [1]
At the same time, drug price adjustment has also played a positive role in the adjustment of enterprise production structure. The relevant person in charge of the National Development and Reform Commission said that the investigation found that some drugs were "dead at reduced prices" reported by the media. Except for the short-term off-shelf situation, a very small number of drugs did withdraw from the market due to poor business management and low market utilization rate of products, but they did not disappear just because of reduced prices. While reducing the price of high-priced drugs and reducing the burden of people's medication, the state has also paid attention to strengthening the price support for low-priced drugs. Especially for the low-priced drugs in clinical shortage, the National Development and Reform Commission has appropriately raised the price on the basis of cost and price investigation, expert review and extensive listening to the opinions of relevant parties, so as to encourage the production and supply of low-priced drugs and meet clinical needs. [1]
4 Mission Editor
Pharmaceutical manufacturers' mission: to ensure the safety, effectiveness, uniformity and stability of drugs.
first, social publicity. The biological endowment of human beings has been urging human beings to improve their health and prolong their lives as much as possible to ensure human reproduction. Drugs have attracted much attention because of their special effects. In modern society, the right to health and the right to life have become basic human rights protected by law. Therefore, drugs are related to the reproduction and development of the whole human society. The social publicity of drugs is the basis for establishing universal medical care and medical insurance system.
second, the dual role. Drugs can prevent and treat diseases, recover and protect health. However, drugs are toxic in three ways, and any drug has different degrees of toxic and side effects. Therefore, with proper management and proper use, drugs can save lives and protect health. On the contrary, it will degenerate into a terrible poison, endangering human health and life safety.
third, the oneness of quality. The physical, chemical, biopharmaceutical, safety, effectiveness, stability, uniformity and other quality indicators of drugs must meet the standards prescribed by the state. Only drugs that meet the national standards can guarantee the curative effect. Lower or higher than the prescribed quality standards may reduce or even lose the efficacy of drugs or aggravate the toxicity and side effects of drugs. Therefore, drugs entering the circulation channels are only allowed to have qualified products, and absolutely not allowed to have defective products or off-grade.
fourth, the professionalism of identification. The quality of drugs, authenticity, the average consumer is difficult to identify. We must have professional technicians and specialized institutions, use scientific methods and meet the requirements of instruments and equipment according to legal standards, in order to make an appraisal.
fifth, the limitation of application. Due to the lack of professional medical and pharmaceutical knowledge needed to treat diseases and prevent diseases, people can only use drugs rationally under the guidance of licensed doctors and pharmacists, even under the supervision of medical staff, so as to achieve the purpose of preventing diseases and protecting health. If drugs are abused, it is easy to cause poisoning or drug-induced diseases. In addition, people sometimes need a little medicine when they are sick.
5 classified editing
Drugs include cold medicines, antipyretics, stomach medicines, laxatives, hypnotics and other drugs beneficial to health according to their uses, and Chinese herbal medicines, Chinese patent medicines, Chinese and western medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum, vaccines, blood products and diagnostic drugs according to their properties.
6 export prospect editor
In p>21, China will surpass India to become the most popular international drug purchasing place.
China's exports of APIs and active ingredients are expected to increase from $5.63 billion in 27 to $9.9 billion in 21, while India will increase from $1.7 billion in 27 to $2.76 billion in 21.
These products exported by China mainly include antibiotics, vitamins, amino acids and organic acids, and their main markets include the European Union, the United States, India and Japan. India will continue to lead in the export of finished drugs, and the export volume is expected to increase from $4.8 billion in 27 to $6.4 billion in 21. China increased from $7 million in 27 to $1.88 billion in 21.
In the international procurement market, China ranks first, India ranks second and South Korea ranks third in terms of the popularity of drug outsourcing, based on comprehensive indicators such as cost, market opportunities and risk factors. Although Indian medicine exports exceed China's, China has made a leading position in the export of raw materials and active ingredients.
7 development status editor
"The enthusiasm for new drug research and development in China is high, there are many people, the demand is urgent, the market is vast and the government attaches importance to it. It can be said that opportunities are frequent, but the current situation is not optimistic." At the 4th China International Biomedical Development Summit, this view is very representative.
1. New drugs are hard to find, and imitation drugs are hard to imitate
"It is increasingly difficult to find new drugs with existing research and development models and processes. On the basis of existing life science and technology, after rounds of screening, almost all known biochemical molecular reactions and biochemical enzyme reactions have been developed by the pharmaceutical industry. " John Duan, a senior examiner and clinical pharmacologist of the US FDA, said.
The output rate of new drugs is decreasing, the research and development costs are rising, the clinical time is too long, and the listing process is too slow ... These cliché s about drug innovation still exist, and the sustainability of domestic biopharmaceutical development is difficult because of its weak foundation and lack of accumulation.
The biopharmaceutical industry has been growing at a faster rate than the overall pharmaceutical industry, but there is still a considerable gap between domestic biopharmaceutical technology and developed countries, and the scale of biopharmaceutical enterprises is much smaller than that of chemical pharmaceutical enterprises. The route of "me to (imitation) -me better (better imitation) -me new (innovation)" that domestic chemical drugs have been taking is not easy for biological drugs. The reason is that the bioequivalence of biosimilars is difficult to determine.
in fact, the production process between chemical drugs and biological drugs is very different. Chemical drugs are simple small molecular compounds. By controlling the chemical formula, products with similar structures can be easily produced. At the same time, it can be confirmed whether the generic drugs have the same efficacy as the original patented products through laboratory tests. However, the situation of biopharmaceuticals is completely different, and the difference of a tiny group will lead to very different effects. Therefore, whether in the United States or China, it is very difficult for biosimilars to obtain regulatory approval. However, if it is proved to be bioequivalent by large-scale clinical trials, the cost and time will be considerable.
Jin Gang, senior vice president of Shanghai Biochip Company, said that biopharmaceuticals are already a high-input and high-risk industry. Generic drugs have no patent protection, and great efforts have been made to do clinical trials. As a result, the market is unprotected, and it is easy to be copied by other competitors, and profits are rapidly reduced. Therefore, in the United States, no VC is willing to accept drugs without patents. Even with complete patent protection, there is still a long way between patented technology and products that can be listed, and even many patents themselves do not have the possibility of listing or the target market is too small to be listed. In other words, the developed products should not only have biological medicine, but also have complete patent protection.
2. Incomplete docking of funds and technology
After returning to China for more than a year, Zhang Lei, a doctor of immunology and medicine, found some phenomena that puzzled him: domestic R&D institutions and some biological companies were so poor that it was difficult to transform R&D and achievements; At the same time, investment companies are afraid to inject capital easily because of the long investment cycle, no clear prospect and no next home.
In fact, due to the high growth of the pharmaceutical industry, a lot of funds revolve around medicine, but it is understood that the funds attracted by domestic biomedicine only account for about 5% of the total medical financing. In addition, the general financial investment mostly hopes to see benefits in a short time, while it takes a long time for a drug to be listed. Even if it is listed, the subsequent risks still exist. Relatively speaking, strategic investment pays more attention to long-term benefits, which can take several years to raise funds and help enterprises make strategic planning and management optimization.
Li Yi, a partner of BIOVIDA China Fund, said that there are still many investment opportunities in the pharmaceutical industry. As professional investment companies, they may choose some early-stage enterprises with breakthrough platform technology or huge market. Even if these enterprises are very small or need a long return on investment, investment companies are willing to accept them as long as they have the characteristics of efficient and cooperative management team, independent products, obvious competitive advantages, clear market opportunities and sustainable business model.
not many domestic enterprises can meet the above standards. In addition, because the upstream and downstream dependency chain has not been established, many domestic enterprises simply take research and development as the leading factor, and then transfer projects, lacking long-term strategic positioning and market considerations.
"In fact, there is no shortage of biological R&D talents in China, but there is no enterprise-oriented innovation system or venture capital market. China's biomedical industry has great potential, but its model is unclear." An industry insider commented.
3. Looking for a bio-medicine kindling
Zhang Faming, president of Sino-American Crown Biotechnology (Beijing) Co., Ltd., believes that in the past, our research and development model was to find a needle that can cure diseases in a pile of firewood with a magnifying glass, and we needed to set a fire to burn the unwanted firewood, so what was left was the needle. In the research and development of new drugs, the biomarker is this match that can burn straw.
The so-called biomarker is to find some characteristic biochemical indexes that can be objectively measured and evaluated by studying the knowledge of genomics and oncology, so that we can know the organism in which the body is currently located.