Explanation of "New Drug Approval Measures"


1. Purpose and meaning

Drugs have a special and important relationship with human life and health, especially when new drugs are used in clinical treatment of various diseases, sufficient experimental data must be provided to prove their safety, effectiveness, and stability, and they must be strictly reviewed by the national health administration. Only after approval can it be officially produced, sold and applied. The purpose of new drug management is to use legal methods to manage new drugs, strictly enforce national laws, and new drugs that have not been approved shall not be produced, sold or used. The core of management is to solve two problems, namely: ① review and approve whether a new drug can be tested in humans for clinical research; ② review and approve whether a new drug can be officially put into production as a drug.

Therefore, new drug management is of great significance to ensure the quality of new drugs and the safety, effectiveness and stability of human drugs.
2. Background

The drug management laws of many countries in the world have clear regulations on the approval of new drugs, the monitoring of adverse drug reactions and the elimination of drugs, and the administrative departments of health have formulated regulations and technical standards and guidelines for implementation. my country promulgated the "Drug Administration Law" in 1984, and implemented the "New Drug Approval Measures" on July 1, 1985. After that, the Ministry of Health issued the "New Drug Approval Procedures" and "Several Supplementary Regulations on New Drug Approval Management" "Regulations on the Registration and Clinical Treatment of Foreign Drugs in China", "Administrative Measures on Imported Drugs", and "Regulations on the Protection of Chinese Medicines." The supplementary regulations and explanations on Chinese medicine issues in the "New Drug Approval Measures" have continuously improved my country's new drug approval management. Mankind’s understanding of strengthening the management of new drugs has not reached the current level of comprehensive understanding at one time, but has realized the importance of strengthening the management of new drugs after many serious international drug accidents have occurred and the painful price has been paid. For example, in the sulfa elixir incident in 1937, a sulfa elixir prepared by a US pharmaceutical factory with industrial diethylene glycol instead of alcohol was not clinically tested before it was marketed, causing 107 deaths, and animal experiments proved that the toxicity came from industrial diethylene glycol. . In 1961, due to lack of safety data during pregnancy, 11490 malformed fetuses were caused in Germany, Britain and Japan. The Simeng incident in Japan in 1964 was an anti-intestinal infection drug chlorosulfaquine that caused more than 7,800 people to suffer from optic nerve disorders and motor paralysis. In addition, there are many drug damage incidents due to the lack of strict legal management of new drug research and development. The safety of the new drug has not been verified, and it has been put into clinical application, which has caused serious drug damage, teratogenicity, death, and pain. The cost of this forced governments to face reality and modify or strengthen the management of new drug development. It is clearly stipulated that before a new drug is marketed, the research and production unit must provide the new drug review center with detailed test data on the safety, effectiveness, and stability of the drug, and carefully review and approve one by one in accordance with the prescribed new drug review items and procedures. At present, the U.S. FDA (U.S. Food and Drug Administration) has a relatively complete set of measures for the legalization of new drugs, which has a greater impact on all countries in the world. The new drug management methods of various countries are similar and increasingly consistent, only due to the economic strength of each country. The difference is currently not completely the same as the US new drug management method. Since the implementation of the unified approval of new drugs by the Ministry of Health in my country, as of December 31, 1994, a total of 1,123 new drugs have been approved, including 763 Western medicines and 360 Chinese medicines.

Third, the main points of the document "New Drug Approval Measures" Chapter 1 General Provisions Article 2 stipulates that "new drugs refer to drugs that have not been produced in my country." "Any drugs that have been produced add new drug indications, change the route of administration, and change the dosage form are also within the scope of new drug management." Drugs that have not been produced in my country include: innovative drugs that have not been produced at home and abroad; for example, the antimalarial drug artemisinin and the antitumor drug cantharidin are all unique new drugs in my country. Generic drugs that have been produced abroad but have not been produced in my country; such as anti-hepatitis drug malotixate, and antiemetic drug ondansetron. New prescription drugs prepared from raw materials that have been produced, also known as compound preparations, have seen a large number of compound preparations used in clinics at home and abroad. For drugs that are compound preparations, they must provide single and compound drugs before applying for clinical research. The efficacy test data can only be used after confirming the efficacy of the compound preparation. For drugs that are already on the market, if new indications are added, or the route of administration is changed, or the dosage form of the drug is changed; injection administration is changed to oral dosage form. In order to confirm that the original drug quality characteristics have not changed, sufficient provision should be provided after research. The data is explained, so it is also included in the scope of new drug management.

(1) Classification and naming of new drugs

Article 4 of Chapter 2 of the New Drug Examination and Approval Measures stipulates the classification and naming of new drugs (Chinese medicine and Western medicine) respectively. Different types of new drugs require different research requirements. Therefore, the classified supervision and management of new drugs can not only achieve the right number of seats, but also improve the efficiency of developing new drugs.

Western medicines and new Chinese medicines are divided into five categories. From the specific details of the classification, it can be seen that the classification of Western medicines emphasizes comparison with foreign countries for innovation. Raw materials and their preparations can be co-existed and declared. New excipients are similar to imported raw materials. Western medicines that change the dosage form or change the physical properties but do not change the therapeutic effect shall be declared as category 4 new drugs. New traditional Chinese medicines emphasize contrast with traditions in order to inherit and carry forward the precious heritage of the motherland's pharmacy. In addition, new biological products are divided into four categories; new pharmaceutical excipients are divided into two categories.

Classification also has the following characteristics:

(1) The principle of quality first. This is the essence of classified management. For example, the quality characteristics of innovative drugs have not been fully understood and mastered by humans; while the physical and chemical characteristics and quality standards of imitations have been reported in foreign countries or have been listed in a country’s pharmacopoeia, which can be referenced and documented. . Therefore, the two should be treated differently and classified management. The application materials, approval procedures, approval authority and protection time are different.

(2) The principle of starting from reality. According to the actual situation of my country's medicine, formulate a classification method for the development and management of new drugs. For example, traditional Chinese medicine accounts for a large proportion of Chinese medicines, and most of them have been used for many years, so the classification methods of Chinese and Western medicines are different. In addition, in the implementation of classified management, the judgment of each new drug category must be based on reality.

(3) The principle of promoting the development of new drugs. Classified management is conducive to rationally investing limited people, money, and materials in the development of various new drugs in order to create more new drugs and ensure the quality of new drug development. In order to prevent the confusion of drug names and cause many practical difficulties in the use of prescription formulas, the naming of new drugs should be listed as one of the important contents of the approval of new drugs by the governments of various countries. The World Health Organization (WHO) Expert Committee has proposed two main principles for drug naming:

①The pronunciation of the name of the drug should be clear and easy to distinguish, the whole word should not be too long, and it should be avoided to be similar to the name of the drug currently in use;

②The names of drugs belonging to the same pharmacodynamic category should seek an appropriate method to show this relationship; any name that is easy to make patients guess the effect from anatomy, physiology, pathology and therapeutics, generally should not be used . The WHO has also reviewed and published the single-drug generic name "international nonpropri-etary name".names for pharmaceutical substance, INN).

Article 5 of the "New Drug Evaluation Measures" stipulates that "the name of a new drug must be clear, short, and scientific, and code names and names that are easy to confuse or exaggerate curative effects are not allowed." The name of the new drug to be declared should include three names: Chinese name, Pinyin name, and Latin name. The names used in other domestic systems should be as consistent as possible and consistent with the "International Non-Patent Drug Names" proposed by the World Health Organization. Yes, try to use a unified Latin name to facilitate communication.

The names of proprietary Chinese medicines are confusing, which affects the quality management of medicines. The Pharmaceutical Administration Bureau of the Ministry of Health has rectified this, and in 1989 and 1994 issued ministerial standards for 1,600 kinds of proprietary Chinese medicines, and at the same time implemented a unified national number of proprietary Chinese medicines.

(2) Research on new drugs

"New Drug Approval Measures" Chapter 3 Article 7 specifies the content of new drug research, including process routes, quality standards, preclinical pharmacology and clinical research. While developing the new drug technology, the research unit must study the physical and chemical properties, purity and inspection methods of the drug, pharmacology, toxicology, animal pharmacokinetics, clinical pharmacology, prescription, dosage, dosage form, bioavailability, stability, etc. , And proposed a draft of drug quality standards. The research and development of new drugs can be roughly divided into two stages. The first is the research stage, which focuses on the discovery of new drugs and various experiments and techniques in preclinical pharmacology, pharmacology, and toxicology. The second is the development stage, that is, entering clinical research and use. 
1. Preclinical Pharmaceutical Research
①The process route, systematic analysis (physical and chemical properties, purity, identification, impurities), stability, and quality standards of clinical drugs for raw materials should have sufficient experimental data and samples, and should be used for pre-clinical preparation research, analysis and testing. Raw materials required for pre-clinical trials and qualified batch raw materials are provided.
②Research on new drug preparations: In the entire process of researching new drugs (pharmacodynamics, toxicology, clinical), the raw materials must be made into certain preparations and tested with specific administration methods. At the same time, the drug preparations are based on drugs. The final form is directly used by patients. Therefore, the research of pharmaceutical preparations is very important. Its ultimate goal is to provide clinical pharmaceutical dosage forms with high curative effect, low toxicity and convenient use. The ideal pharmaceutical dosage form should be the unity of effectiveness, safety, stability, bioequivalence, uniformity and applicability, so the choice and design of the dosage form are the first, for example, intestinal deworming tablets are changed to oral Suspension dosage form, because the preparation process of suspension adopts colloid mill, for the change of this dosage form, it is necessary to consider whether the excessively fine particles may increase absorption, leading to increased toxic and side effects. Others, due to different preparation processes, the dissolution rate varies greatly; there are many examples of different dosage forms and different therapeutic effects, which illustrates the importance of researching pharmaceutical preparations.
The formation of pharmaceutical dosage forms often requires the use of the characteristics of some excipients to complete, and the final dosage form is stored in different packaging materials for a long time. Therefore, while studying pharmaceutical preparations, it is necessary to investigate whether the excipients are present in the determination of the main drug content in the dosage form. Interference, the impact of packaging materials on the stability of the dosage form, according to the experimental results, targeted measures, reasonable selection of excipients, and packaging design. For some special drugs, studies on bioavailability or in vitro dissolution should also be carried out. The three parameters of bioavailability, Cmax, Tmax, and AUC, are of great significance for understanding drug absorption in the body, predicting drug efficacy, and guiding clinical use. . In vitro dissolution can also be used as an effective quality indicator to screen the dosage form, prescription, and technology of new drugs. It must be pointed out that any in vitro test has practical value only when it is related to in vivo results.
③ Develop draft quality standards for clinical drugs (raw materials and preparations) and provide qualified clinical preparations.
To declare a new drug, it is necessary to provide quality standards. Class 1 and 2 new drugs provide quality standards for raw materials and their preparations. Class 3 new drugs are the same as Class 4 new drugs if they are compound prescriptions for old drugs. Only preparation quality standards are provided. The formulation of new drug quality standards should be based on the production and quality control of the above-mentioned raw materials and preparations, combined with the requirements of pharmacology and clinical use, and comprehensively and comprehensively formulated to ensure the safety and effectiveness of the drugs and comply with the national pharmacopoeia. Or other legal standards.

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