Chinese name
Drugs and chemical reagents
Foreign name
medical science
according to
People's Republic of China (PRC) Drug Administration Law
function
Prevention, treatment and diagnosis of human diseases
include
Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines
diversification
More than 400 varieties
1 function introduction editing
On the user side, it is aimed at preventing, treating and diagnosing human diseases. It is regular to adjust people's physiological functions purposefully.
Indications, usage and dosage requirements; From the way of use: in addition to the appearance of patients can not identify their internal quality, many drugs need to be used under the guidance of doctors, rather than by the choice of patients. At the same time, the use method, quantity, time and other factors largely determine the use effect. Misuse can not only "cure", but also "cause disease" and even endanger life safety. Therefore, medicine is a special commodity.
1. Variety is complex: there are about 20,000 specific varieties in the world, about 5,000 kinds of traditional Chinese medicine preparations and 4,000 kinds of western medicine preparations in China. Therefore, the types of drugs are complex and diverse.
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. Strictly control the quality of drugs: drugs are directly related to people's health, even life and death, so their quality must not be sloppy. We must ensure the safety, effectiveness, consistency and stability of drugs.
In addition, the quality of drugs also has remarkable characteristics: different from other commodities, it has quality grades: excellent products, first-class products, second-class products, qualified products and so on. , can be sold, and drugs can only be sold if they meet or do not meet the requirements.
2 management specification editing
The conformity of drug quality not only means that the product quality conforms to the registered quality standard, but also makes the whole process conform to the good manufacturing practice (GMP).
Good manufacturing 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 process affecting 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 editing
20 13, 1 At the beginning of the year, the National Development and Reform Commission issued a notice, and decided to adjust the maximum retail price limit of drugs such as respiratory drugs, antipyretic and analgesic drugs and specialized special drugs from 20 13, 1. * * * involving 20 kinds of drugs, more than 400 varieties, more than 700 representative dosage forms, with an average price reduction of 65438. [ 1]
The earliest medical insurance varieties, the average price reduction of 40%.
According to the relevant person in charge of the Price Department of the National Development and Reform Commission, for drugs included in the government pricing range (mainly drugs in the medical insurance catalogue), the Development and Reform Commission implements a price dynamic adjustment mechanism based on factors such as drug cost and market price changes, generally every 2-3 years. Adjust once. Since 200 1, the national development and reform commission has issued three rounds of drug price adjustment programs, involving nearly 2000 kinds of drugs. The first batch of varieties entering the medical insurance catalogue, the cumulative price reduction rate reached an average of 40%, up to 80%; The latest varieties entering the medical insurance catalogue have just begun to reduce their prices, with an average of about 15%. [ 1]
The first round of adjustment from 200/kloc-0 to 2003 was the first comprehensive adjustment of drugs managed by the government. [ 1]
In the second round of adjustment in 2006-2007, combined with the varieties of medical insurance catalogue, the government once again carried out comprehensive price management of drugs. [ 1]
From 20 1 1 to 20 12, the national development and reform commission made a comprehensive adjustment to the government-managed valuable chemicals. [ 1]
Since 20 1 1, eight drugs, including 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, and most of them belong to commonly used clinical drugs. At this point, the price adjustment of chemicals by the National Development and Reform Commission has been basically completed, and the price adjustment of proprietary Chinese medicines will start from 20 13. [ 1]
Appropriately increase the price of low-priced drugs in clinical shortage
According to the follow-up investigation of previous drug price adjustments by the relevant departments of the National Development and Reform Commission, this 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 60 billion yuan every year. In this round of price adjustment, the average decline of high-priced drugs reached 20%. Taking the treatment of Alzheimer's Harmo's disease (Alzheimer's Harmo's disease) as an example, the price of 1.5mg×28 capsule (produced by Novartis, trade name "Eisner Long") decreased by 39% the day before and the day after 19.8 yuan. [ 1]
At the same time, the adjustment of drug prices 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 reported by the media were "dead at reduced prices". Except for the short-term removal from the shelves, a very small number of drugs did withdraw from the market because of poor business management and low market utilization rate of products, but they did not disappear just because of price reduction. While reducing the price of high-priced drugs and reducing the burden of people's medication, the state also pays attention to strengthening the price support for low-priced drugs. Especially for the low-priced drugs that are in short supply in clinic, the National Development and Reform Commission, on the basis of cost and price investigation, expert review and extensive listening to the opinions of relevant parties, appropriately raises the prices, encourages the production and supply of low-priced drugs, and meets the clinical needs. [ 1]
4 task editing
The mission of pharmaceutical manufacturers: to ensure the safety, effectiveness, uniformity and stability of drugs.
First, social propaganda. The biological endowment of human beings has been urging human beings to improve their health and prolong their life 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 public announcement of drugs is the basis of establishing universal medical care and medical insurance system.
Second, the duality of roles. Drugs can prevent and treat diseases and restore and protect health. However, drugs are toxic in three aspects, and any drug has different degrees of toxic and side effects. Therefore, drugs can save lives and protect health as long as they are properly managed and used. 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. If it is lower than or higher than the specified quality standard, it may reduce or even lose the curative effect of the drug or aggravate the toxic and side effects of the drug. Therefore, only qualified drugs are allowed to enter the circulation channel, and defective or unqualified products are absolutely not allowed.
Fourth, the professionalism of appraisal. The quality and authenticity of drugs are difficult for ordinary consumers 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 before we can make an appraisal.
Fifth, the limitations of application. Due to the lack of professional medical and pharmaceutical knowledge for treating and preventing diseases, people can only use drugs rationally under the guidance of Yamatonokusushi, a medical practitioner, or even under the supervision of medical staff, so as to prevent diseases and protect health. If drugs are abused, poisoning or drug-induced diseases may easily occur. In addition, people sometimes need a little medicine when they are sick.
5 classified editing
Drugs are classified into cold medicines, antipyretics, stomach medicines, laxatives, sleeping pills and other drugs beneficial to health according to their uses, and into Chinese herbal medicines, Chinese herbal pieces, 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 nature.
6 Export Foreground Editor
In 20 10, 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 US$ 5.63 billion in 2007 to US$ 9.9 billion in 20 10, while Indian exports will increase from US$ 0.7 billion in 2007 to US$ 2.76 billion in 20 10.
These products exported by China mainly include antibiotics, vitamins, amino acids and organic acids, and the main markets include the European Union, the United States, India and Japan. In the export of finished drugs, India will continue to lead, and the export volume is expected to increase from $4.8 billion in 2007 to $6.4 billion in 20 10; China increased from $700 million in 2007 to $654,380,880 in 2065,438+00.
In the international procurement market, the popularity of drug outsourcing, including comprehensive cost, market opportunities and risk factors, ranks first in China, second in India and third in South Korea. Although Indian medicine exports surpass China's, China is already in a leading position in the export of raw materials and active ingredients.
7 development status editor
"China's new drug research and development enthusiasm is high, there are many people, the demand is urgent, the market is broad, and the government attaches importance to it. It can be said that opportunities are frequent, but the status quo is not optimistic. " This view was very representative at the 4th China International Biomedical Development Summit.
1. New drugs are hard to find and generic drugs are hard to copy.
"The existing research and development models and processes are increasingly difficult to find new drugs. 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 FDA examiner and clinical pharmacologist, said.
The output rate of new drugs is declining, the research and development cost is rising, the clinical time is too long, and the listing process is too slow ... These cliches about drug innovation still exist, and the sustainability of domestic biopharmaceutical development is unsustainable because of weak foundation and lack of accumulation.
The biomedical industry has been growing at a faster rate than the whole pharmaceutical industry, but there is still a considerable gap between domestic biomedical technology and developed countries, and the scale of biomedical enterprises is far smaller than that of chemical pharmaceutical enterprises. The route of "me to -me better -me new" that domestic chemical drugs have always taken is not easy for biological drugs. The reason is that the bioequivalence of biosimilars is difficult to determine.
In fact, the production process of 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 drug has the same curative effect as the original patented product through laboratory testing. But the situation of biopharmaceuticals is completely different, and the difference of a very small group will lead to very different effects. Therefore, whether in the United States or China, it is very difficult for biosimilars to obtain the approval of the regulatory authorities. But if it is proved to be bioequivalent through large-scale clinical trials, the cost and time are considerable.
Jin Gang, senior vice president of Shanghai Biochip Company, said that biopharmaceuticals are already high-input and high-risk industries. Generic drugs have no patent protection, and great efforts have been made in clinical trials. In this way, the market is not protected, and it is easy to be copied by other competitors, and profits are rapidly reduced. So in the United States, no venture capitalist is willing to accept drugs without patents. Even with complete patent protection, there is still a long way to go 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 products developed should not only have biomedicine, but also have complete patent protection.
2. Capital and technology are not completely connected.
After Zhang Lei, a doctor of immunology medicine, returned to China for more than a year, he found some phenomena that puzzled him: domestic R&D institutions and some biological companies were poor in R&D and it was difficult to transform their achievements; At the same time, investment companies are afraid to inject capital easily because of their long investment cycle and uncertain prospects.
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 whole medical financing. In addition, most general financial investments hope to see benefits in a short time, while it takes a long time for a drug to go on the market. Even if it goes public, the follow-up risks still exist. Relatively speaking, strategic investment pays more attention to long-term benefits, and it can take several years to raise funds to help enterprises carry out strategic planning and management optimization.
Li Yi, partner of BIOVIDA China Fund, said that there are still many investment opportunities in the pharmaceutical industry. As a professional investment company, you may choose some early enterprises with breakthrough platform technology or huge market. Even if these enterprises are small, or need a long return on investment, investment companies are willing to accept them as long as they have the characteristics of efficient cooperative management team, independent products, obvious competitive advantages, clear market opportunities and sustainable business models.
There are not many domestic enterprises that can meet the above standards. In addition, because the upstream and downstream dependence 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 innovation system with enterprises as the main body and no venture capital market. China's biomedical industry has great potential, but the model is not clear. " An industry insider commented.
3. Looking for biomedical kindling
Zhang Faming, president of Sino-American Guanke Biotechnology (Beijing) Co., Ltd. believes that in the past, our research and development model was to look for a needle that could cure diseases in a pile of firewood with a magnifying glass. We need to set fire to unnecessary firewood, so all that's left is needles. In the research and development of new drugs, biomarkers are such matches that can burn straw.
The so-called biomarker is to find some characteristic biochemical indicators that can be objectively measured and evaluated through the study of genomics and oncology knowledge in a common physiological or pathological or therapeutic process, and to understand the current biological process of the body through them.
In fact, this is a change in research and development ideas. John Duan said that the conventional research method of new drugs is to carry out basic research first, then look for compounds with pharmacological activity from a large number of compound sample libraries, and then carry out steps such as chemical structure optimization design, pre-clinical research and clinical trials. Generally, less than 1 10,000 compounds with pharmacological activity are screened out, and even fewer can reach clinical trials. It can be transformed into starting from disease research, studying the principle of the disease itself, figuring out the most influential areas, and conducting targeted research and screening. "Better targeting recognition ability can not only improve the screening efficiency of lead compounds, but also judge the effectiveness of drugs more accurately in the early stage of clinical research.
"When choosing a project, you must have a vision. We must know whether there is a sufficient market for R&D products and how long it will take for such drugs to be eliminated. If you don't learn dragon slaying, you can't find dragons at all. " Participants described.
Some organizations predict that by 20 10, China will become the seventh largest pharmaceutical market in the world, and the demand of China citizens in the health field will increase greatly. Biomedicine has the characteristics of strong specificity and high accuracy, and there are still many fields that can be studied. It's just that China's biomedicine is still in the primary stage of industry and needs a long time to cultivate.
8 fake drug profile editor
Medicines (5 pieces)
According to Article 48 of the Drug Administration Law of People's Republic of China (PRC), the production (including preparation, the same below) and sale of counterfeit drugs are prohibited.
In any of the following circumstances, it is a counterfeit drug:
(a) the ingredients contained in the drug are inconsistent with the provisions of the national drug standards;
(2) passing off non-drugs as drugs or passing off other drugs as drugs.
Drugs under any of the following circumstances shall be treated as counterfeit drugs:
(a) prohibited by the drug supervision and administration department of the State Council;
(2) Producing, importing or selling without the approval of this Law;
(3) deterioration;
(4) being polluted;
(five) the use of raw materials that must obtain the approval number in accordance with this law, but have not obtained the approval number;
(six) the indications or functional indications are beyond the prescribed scope.
supplement
Xiong Xuanguo, vice president of the Supreme People's Court, pointed out at the press conference held by the State Council Press Office that the drugs endorsed by celebrities should be investigated for criminal responsibility even if they know they are counterfeit drugs.
Speaking of celebrity endorsements, Xiong Xuanguo said that from the perspective of judicial interpretation, the first thing is to provide advertisements for this kind of behavior. According to the provisions of the criminal law, the crime of producing and selling counterfeit drugs and inferior drugs is a deliberate crime, which constitutes the crime of * * * on the premise of knowing or should know that others produce and sell counterfeit drugs and inferior drugs. Therefore, if the celebrity's endorsement behavior is knowing that others are producing and selling counterfeit drugs and inferior drugs, it is ok to be punished as a * * * offender, which is in line with the provisions of the criminal law, but this premise is very important.
It is understood that on May 3, 2009, the Supreme People's Court and the Supreme People's Procuratorate signed the Interpretation on Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases of Producing and Selling Fake Drugs and Inferior Drugs, which came into effect on May 27, 2009. The Interpretation clarifies some difficult problems in the application of law in handling criminal cases of producing and selling counterfeit drugs and inferior drugs.
Avoid counterfeit drugs
Step 1: Choose a regular pharmacy network.
If consumers want to distinguish the authenticity of information, they must first go to a legal and regular pharmacy network to buy it. Statistics show that as of 201010/5, there are 2588 legal websites providing drug service information in China, including 54 websites involving drug transactions. Of the 54 websites that provide drug trading services, only 33 have the legal qualification to sell drugs to individuals. Choosing a regular pharmacy network is an important step to avoid buying fake drugs.
Step 2: How to tell whether a drug is true or false?
Appearance mentioned in drug appearance identification skills has two meanings. First, it refers to the appearance involved in drug packaging, including packaging boxes, packaging boxes, medicine bottles, labels, instructions and so on. The other refers to the appearance and shape of the drug itself.
When judging whether the inspected products are counterfeit or inferior drugs by visual inspection and identification, we should pay attention to the following issues:
1. The most basic technical basis for identification is the comparison method.
This is a method based on the comparison between genuine and fake products. Therefore, drug inspectors should understand and be familiar with the product appearance of various regular manufacturers, which requires us to accumulate experience in the usual inspection work and constantly improve the identification level.
2. Check the source channels of drugs
In the process of drug inspection, it is necessary to review the source certificates of various drugs, carefully identify the authenticity of delivery notes, and strengthen the inspection of relevant situations. The production and sales channels of counterfeit and inferior drugs are obviously different from those of regular products.
Step 3 check the drug price
Generally, the price of counterfeit and inferior drugs is obviously lower than that of genuine drugs, and some of them are even lower than the product cost price. In drug supervision and inspection, it is found that the price of drugs is obviously lower than or deviated from the cost price, which should be paid attention to and sampled in time.
4. Drug fraud is generally regular.
Best-selling varieties, tight varieties, well-known brands and expensive drugs are mostly counterfeited, and the phenomenon of confusing the real with the fake also occurs from time to time, and the means of counterfeiting are constantly changing. Drug inspectors should respond flexibly according to the actual situation.
5. The drug appearance identification is very on-site.
Therefore, its methods and basic environment are also limited. If possible, we should try our best to carry out experiments through rapid inspection and identification, and draw further conclusions, such as TLC and chemical reaction identification.
Distinguish between true and false
Simple identification method:
First of all, just look at the approval number on the package.
1. On the packaging of drugs, you must be able to see the approval number: "Chinese medicine label H (or Z.S.J.B.F)+8 digits", which means drugs approved for production and marketing by the State Administration of Pharmaceutical Products. The letter H stands for chemical drugs, Z stands for proprietary Chinese medicines, S stands for biological products, J stands for domestic packaging of imported drugs, and B stands for adjuvant drugs, F.
2. If there is no "National Medicine Standard" on the package, it is definitely not a medicine. If there is a "national medicine quasi-word" to log in to the State Administration of Pharmaceutical Products for data query, and enter the name of the drug or the letters and 8 digits after the "national medicine quasi-word", you will find the real medicine, but what you can't find is the fake medicine.
3. If the approval number is: X drug series H(Z)+4-digit year number +4-digit serial number, this approval number is a hospital preparation, which can only be used in our hospital and cannot be sold in other hospitals and pharmacies.
4. If the expiration date is not marked or changed on the drug package, or the production batch number is not marked or changed, the drugs that exceed the expiration date are inferior drugs.
5. Identification methods of health food and food.
(1). On the packaging of health care products, you can definitely see the approval number of the State Pharmaceutical Administration: the word G(J)+8 of national food is a number, and the letter G stands for domestic J stands for import. Or the approval number of the Ministry of Health: Wei Shi Jian Zi (Wei Shi Jin Jian Zi) +8 digits. It is also stipulated that the package or label must be marked with a special logo for health care products: "Police Mobile Force", with a pattern similar to that of the police mobile force, with the words "health food" below and the approval number "health food" below. Those who don't have the approval number of the police mobile force and health food are fake health care products.
(2) The "food production license number" marked on the food package begins with QS, followed by the serial number 12. There is a kind of "health permit number", which starts with the abbreviation of each province, followed by a serial number, such as Yu Wei Food Certificate, Yue Wei Food Certificate and Huwei Food Certificate. Its logo is a deformed blue Q with a white S on a rectangular white background. It's called QS logo, and there are four words of quality and safety under QS.
6. When identifying drugs, it depends on whether there is an approval number: "National Medicine Zhunzi". If there is a national medicine standard, you can log in to the database of the State Administration of Pharmaceutical Products. If it is not found, it is a fake medicine. Buying health care products depends on whether there is an approval number of the police mobile force and the state, or you can log in to the database of the State Medical Supplies Administration. What you can't find is fake health care products. When buying food, you should check whether there is QS mark and food production license number.
The identification method is complicated: professional institutions (drug control institutes) can judge the authenticity of drugs through chemical and physical detection methods.
9 storage principle editor
1. Varieties with interactive properties, easy to cross-taste and wrong names should also be stored separately.
2, narcotic drugs, psychotropic drugs, toxic drugs should be stored in a special library or counter, designated person to keep.
3. Dangerous goods shall be strictly implemented in accordance with the Interim Measures for the Management of Hazardous Chemicals Storage, the Rules for the Management of Explosives and the Rules for the Management of Warehouse Fire Safety issued by the Ministry of Public Security, and shall be stored in a special warehouse with special facilities according to their dangerous qualities.
4, effective drugs according to the period of validity, according to the batch number in turn stacked pattern. And according to the time limit stipulated in the "China Pharmaceutical Company's Responsibility System for Adjusting and Pulling Medical Commodities", report to the business department regularly for timely sales.
5, long-term storage of goods afraid of pressure on a regular basis the whole stack piled up, and the necessary spacing measures should be taken between stacks.
6. The returned goods should be stored and marked separately. Need to find out the reason and deal with it in time. Drugs returned due to quality problems, after being approved by the administrative department of health for rework, must be re-inspected and qualified before being returned to stock. Returns shall be recorded (including return unit, date, product name, specification, quantity, return reason, inspection result, processing date, processing situation, etc.). ) and kept it for two years.
7, handling and stacking should strictly abide by the requirements of drug packaging identification, safe operation, to prevent brutal loading and unloading.
(5) Pay attention to the timely rotation of drugs directly pulled from the factory with the same variety in stock, and timely rotation and update of drugs stored by the state and foreign countries.
(six) the implementation of "first in first out", "recent first in first out" and "variable first in first out", according to the principle of batch number. The production batch number, year, month and day, validity period and storage year, month and day shall be registered when the drugs leave the warehouse. It is necessary to release good drugs from the warehouse for acceptance, and it is strictly forbidden to deliver deteriorated or expired drugs.
(seven) all pharmaceutical warehouses, where the storage area is greater than 3000m, should establish a professional maintenance organization, less than 3000m warehouse should have full-time maintenance personnel.
(eight) drug maintenance tasks.
1, to guide the custodian to store drugs scientifically.
2. Check whether the storage conditions of the drugs in stock meet the requirements, cooperate with the keeper to manage the temperature and humidity of other rooms, and adjust the storage conditions in time.
3. Regularly check the circulation quality of drugs in stock. The cycle of circulation spot check is generally one quarter, and the cycle of perishable drugs should be shortened.
4, the problems found in the spot check, put forward opinions and improve maintenance measures. If necessary, cooperate with the custodian to sort out the problematic varieties.
5, according to the change of seasonal climate, formulate drug inspection plan and maintenance work plan, list the key maintenance varieties, and implement them.
6, the establishment of drug maintenance files.
7. Observe the key varieties, investigate the reasons and laws of changes, and provide information for guiding rational inventory, improving storage level and promoting pharmaceutical factories to improve product quality.
8, carry out scientific research on maintenance, and gradually make the storage and maintenance of the warehouse scientific and modern.