Question 2: What is a generic drug? The so-called generic drug refers to the same generic drug as the patented drug in terms of dosage, safety, efficacy, quality, use and indications.
Question 3: What is a generic drug? Generic drugs refer to imitations that are the same as brand drugs in terms of dosage, safety and strength (no matter how to take them), quality, performance and intended use.
Question 4: What is a generic drug? The so-called generic drugs refer to imitations that are the same as patented drugs in terms of dosage, safety, efficacy, quality, function and indications. For example, the best-selling Osimertinib, commonly known as AZD929 1, AstraZeneca is named Tagrisso, and ASSO in India is named TAGASSO, but its main components and curative effects are exactly the same, except that AstraZeneca has a patent. Generally speaking, the relationship with genuine Windows and pirated Windows is the same.
Question 5: What is the specific definition of generic drugs? However, it is precisely because of the above characteristics of generic drugs that some registered applicants fall into the misunderstanding of generic drug research and development, thinking that developing generic drugs is relatively simple. As long as the products that meet the national standards are prepared and simple bioequivalence tests are carried out, they can be equivalent to imitation products. In fact, it must have the same therapeutic effect as generic drugs. On the one hand, it is necessary to confirm that generic drugs and generic drugs have the same safety, on the other hand, it is necessary to confirm that generic drugs and generic drugs have the same effectiveness.
Question 6: The difference between original drug and generic drug. TDG International Co., Ltd. compiled the following contents according to the relevant information provided by the Food and Drug Administration:
The original drug refers to the first drug approved for marketing at home and abroad, with complete and sufficient safety and effectiveness data as the basis for marketing.
Generic drugs refer to drugs with the same active ingredients, dosage forms, routes of administration and therapeutic effects as generic drugs.
Question 7: The difference between original drugs and generic drugs To understand this question, we must first understand the difference between drugs developed in Chu Yuan and generic drugs. The original drug, that is, the original new drug, was approved for marketing after screening thousands of compounds and strict clinical trials. It takes about 15 years of research and development time and hundreds of millions of funds. At present, only large multinational pharmaceutical companies have research and development capabilities. To put it bluntly, the research and development process of new drugs is the process of survival of the fittest. Determining the target of diseases Many diseases are usually caused by an abnormal protein function in or on the cell surface. The purpose of treating diseases is achieved by blocking or enhancing the activity of protein with drugs. To develop new drugs, we must first determine the key proteins and the disease targets of drug research and development. 2. Activity Screening Next, prepare the target protein and screen the biological activity of the target protein. Only 0. 1% indicates that some activities meet the requirements. The scientific research model of the target protein was established, and the active compounds reactive with the target protein were screened out for further study, and the winning compound with stable activity and modifiability was determined as the lead structure. 3. The optimized drug should not only absorb good curative effect, but also avoid adverse reactions. Then, after three years of repeated experiments, the previously screened lead structure is transformed into an optimized molecular structure that meets the requirements of scientific research. 6. Report the characteristics of clinical lead structure. These optimized lead structures must undergo various animal toxicity tests. Only in line with relevant national laws and regulations can we enter clinical trials. After 5-7 years of clinical observation, we can finally determine its curative effect on disease treatment. What is introduced here is only a successful drug research and development process. More research has fallen by the wayside for one reason or another, and the losses suffered by pharmaceutical companies are self-evident. Therefore, developing new drugs is a high-risk industry. This is not the end of the initial drug development. Pharmaceutical companies should also train doctors to use new drugs correctly and control possible adverse reactions and emergency treatment methods. Only in this way can drugs better serve patients and eliminate the pain of diseases. It is difficult for generic drug manufacturers to do this. The difference of curative effect between original drug and generic drug. China is a country that mainly produces generic drugs. With China's entry into WTO, the original drug has been paid attention to. Developed countries coexist with both. Therefore, the concept of the difference between original drugs and generic drugs has been deeply rooted in the minds of doctors and patients in developed countries. In foreign countries, patients go to pharmacies with doctors' prescriptions, and pharmacists will ask patients, do you want original drugs or generic drugs? Patients can choose according to their condition and doctor's advice. The American Academy of Family Physicians released the White Paper on Generic Drugs at the annual meeting of 1998 according to the research conclusions of the American Drug Use Committee for two years. The white paper elaborates on the problem of drug substitution and emphasizes the danger of changing medicine at will. N "In the licensing of generic drugs, its bioavailability means that the generic drug has +/-20% availability of the original research and development product after testing." Therefore, it is difficult to fully guarantee the effectiveness and safety of generic drugs. N "Many generic drugs contain different additives and intrinsic substances, which are different from the drugs of the original R&D pharmaceutical factory, so they are not considered bioequivalent." Generic drugs only copy the molecular structure of the main components of the original drug, but the addition of other components in the original drug is different from that of generic drugs, so there are differences in efficacy between them. N "For drugs needed by critically ill patients, critical situations and critical diseases, generic drugs cannot be forcibly replaced." When giving first aid to patients, try to use the original drugs. N "The American Academy of Family Physicians believes that the licensing of generic drugs to replace the original drugs is limited." Although the white paper of the American Academy of Family Physicians is illegal, the research report shows that the efficacy and safety of the original drug are irreplaceable, especially in the treatment of critically ill patients and diseases. Bioavailability: The degree and speed of drug absorption is an important indicator of new drug evaluation. The so-called bioavailability usually refers to the degree and speed at which drugs are absorbed into the blood circulation when administered by intravenous route. Bioequivalence: refers to the bioavailability of the preparation to be approved and the original patented preparation should be as close as possible.
Question 8: Introduction of generic drugs Generic drugs refer to imitations that are the same as brand drugs in terms of dosage, safety and strength (no matter how to take them), quality, performance and expected use. There will be more than 150 kinds of patented drugs in the world, with a total value of more than $34 billion. After the expiration, other countries and pharmaceutical companies can produce generic drugs. 2065438+March 6, 2006 The General Office of the State Council recently issued the Opinions on Consistency Evaluation of the Quality and Efficacy of Generic Drugs, requesting consistency evaluation of generic drugs approved for marketing before the implementation of the new registration classification of chemical drugs. Generic drugs are drugs with the same active ingredients, dosage forms, routes of administration and therapeutic effects as the original drugs. The consistency evaluation of quality and efficacy means that the approved generic drugs can be consistent with the original drugs in quality and efficacy, and can be replaced by the original drugs in clinic, which is conducive to saving social medical expenses. In the National Catalogue of Essential Drugs (Version 20 12), consistency evaluation should be completed before the end of June 10, 2007 for generic oral solid preparations. For other generic drugs approved for listing before the implementation of the new registration classification of chemical drugs, after the first variety has passed the consistency evaluation, the consistency evaluation of the same variety of other pharmaceutical manufacturers should be completed within 3 years in principle; If it is not completed within the time limit, it will not be registered again.
Question 9: Classification of generic drugs, chemicals and drugs, 1, categories 2, 3, 4, 5 and 6, 1. Drugs not on the market at home and abroad:
(1) raw materials prepared by synthetic or semi-synthetic methods and their preparations;
(2) New effective monomers extracted or fermented from natural substances and their preparations;
(3) optical isomers of known drugs and their preparations prepared by methods such as resolution or synthesis;
(4) Preparing multi-component drugs that have been marketed into drugs with fewer components;
(5) New compound preparation;
(6) The preparations that have been listed in China have added new indications that have not been approved at home and abroad.
2. Preparations that have changed the route of administration and have not been listed at home and abroad.
3. Drugs that have been listed abroad but not yet listed in China:
(1) preparations and their raw materials that have been listed abroad, and/or preparations that change the dosage form but do not change the route of administration;
(2) Compound preparations that have been listed abroad, and/or preparations that change the dosage form but do not change the route of administration;
(3) Preparations that have changed the route of administration and have been listed abroad;
(4) The preparations listed in China have added new indications that have been approved abroad.
4. Raw materials and their preparations that change the acid radical, alkali (or metal element) of listed salt drugs, but do not change their pharmacological effects.
5. Change the dosage forms of drugs that have been listed in China, but do not change the route of administration.
6 raw materials or preparations with national drug standards.