The Information Office of the State Council published a white paper titled "Status Quo of Drug Supervision in China" in Beijing Friday.
Following is the full text:
Status Quo of Drug Supervision in China
Information Office of the State Council of the People's Republic of China
July 2008, Beijing
I. Overview of Drug Supply, Quality and Safety
II. Drug Safety Supervision System and Legal System
III. Policies and Measures Concerning Drug Safety Supervision
IV. Supervision of Traditional Chinese Medicine and Folk Medicine
V. International Exchanges and Cooperation in Drug Safety
Drugs are a special kind of commodity used to prevent, treat and diagnose diseases. Effective supervision of drugs has a great bearing on ensuring the safe use of pharmaceuticals by consumers and on safeguarding the right to life and health of the general public. The Chinese government has always attached great importance to supervision over drug safety, and has always been committed to the goal of strengthening such supervision and guaranteeing public drug safety. For this purpose, it has gradually established and improved the system and laws regarding supervision over drug safety, continuously improved the drug supply system, steadily enhanced the guarantee level for the quality and safety of drugs, actively protected the rights and interests of the public in the use of medications, and persistently strived to improve the health of the people.
I. Overview of Drug Supply, Quality and Safety
The Chinese government is actively creating an open and fair market environment for the development of China's pharmaceutical industry, and vigorously promoting its sustained, rapid and healthy development. Through its unremitting efforts in the past 60 years or so since the founding of the People's Republic of China in 1949, especially in the past 30 years since the adoption of the reform and opening-up policies in 1978, China has not only reversed the situation of inadequacy of medical services and drugs, but also remarkably elevated its guarantee capability regarding the quality and safety of drugs.
At present, China can produce 1,500 types of drug substances, many of which lead the world in terms of output, including penicillin and vitamin C. A number of botanic and natural drugs, such as anti-infective berberine and anti-tumor colchicine have been mass-produced and widely used in China. China's antibiotic, vitamin, hormone, antipyretic and analgesic, amino acid, and alkaloid products take up considerable shares of the international pharmaceutical market. China's artemisinin products are used all over the world, significantly contributing to the international anti-malaria efforts. Today, China can produce over one billion doses a year of 41 types of vaccines against infection caused by 26 kinds of viruses and pathogenic bacteria. Among them, the country's annual output of vaccines for preventing common infectious diseases such as hepatitis B, poliomyelitis (infantile paralysis), measles, pertussis, diphtheria and tetanus, can serve 500 million people. Besides meeting the domestic demand, China also provides vaccines to the World Health Organization (WHO) for disease prevention in other countries. China produces more than 3,000 types of medical devices, among which high-tech diagnosis and treatment products such as the digital X-ray, magnetic resonance, ultrasonic and computed tomography apparatus hold considerable market shares. By the end of 2007, China had 12,591 enterprises producing medical devices, and 6,913 pharmaceutical enterprises (including producers of prepared slices of Chinese crude drugs and oxygen for medical use), of which 4,682 were producers of active pharmaceutical ingredients and preparations.
Recent years have witnessed a marked increase in the total output value and trade volume of China's pharmaceutical industry, which is divided into seven categories - Chinese patent medicines, prepared slices of Chinese crude drugs, bulk chemical drug substances, chemical drug preparations, biologicals, medical devices and hygienic materials. Their total output value rose from137.1 billion yuan in 1998 to 667.9 billion yuan in 2007. From 1998 to 2007, the export trade volume of pharmaceutical industry increased from US$ 3.4 billion to US$ 24.6 billion, and the import trade volume from US$ 1.5 billion to US$ 14.0 billion.
To prevent generic drugs from freely using the research and development data of new drugs, and therefore hindering the motivation for inventing new drugs, China earnestly fulfills its commitments to the WTO and implements a data protection system for drugs. The Regulations for the Implementation of the Drug Administration Law of the People's Republic of China amended in 2002 stipulates that undisclosed data of drug studies and others which are independently acquired and submitted by drug manufacturers or sellers who eventually obtained production or marketing approval for the drugs in question which contain new chemical entities enjoy a six-year protection period.
Furthermore, the state implements special evaluation and approval procedures to encourage the invention of new drugs and the development and research of new drugs for treating difficult, complicated and severe diseases. The special procedures are applicable to the following new drugs: active ingredients which are extracted from plants, animals, minerals and other materials and have not been marketed in China, and preparations containing these ingredients; newly discovered medicinal materials and their preparations; drugs made of chemical materials which have not been marketed domestically or internationally and their preparations and biologicals; new drugs with obvious clinical advantages for treating AIDS, malignant tumors and rare diseases; and new drugs for diseases without effective treatment. From 1998 to the end of 2007, altogether 78 Class I new drugs obtained approval. The manufacturing techniques and levels of pharmaceutical enterprises greatly improved, and a series of new techniques and methods were invented, such as vitamin C two-step fermentation, berberine synthesis, and techniques and apparatus for manufacturing high-purity urokinase. New techniques for the fungal screening, breeding and fermentation of high-yield penicillin spores and the fermentation of cephalosporin C have reached the international advanced level. China can manufacture medium-sized medical equipment for export, and is moving toward the world's top rankings in respect of research into techniques for wearable device, biomedical materials and tissue engineering.
The state has expedited the construction of modern pharmaceutical logistics and chain pharmacies, effectively guaranteeing public access to pharmaceutical product. By the end of 2007, China had 13,000 wholesale pharmaceutical enterprises, 341,000 retail pharmaceutical enterprises and chain store enterprises, and 554,000 rural drug supply outlets, fully satisfying the public's needs for drugs. As the Chinese people's standard of living continues to improve, the per-capita consumption level of drugs is gradually rising, reaching 332 yuan in 2006.
China has established a network for reporting and monitoring adverse drug reactions (ADR). In 1998 China officially joined the WHO Collaborating Center for International Drug Monitoring. In 2004 the state promulgated the Measures on Administration of Reporting and Monitoring of Adverse Drug Reactions, thereby formally adopting a system of reporting and monitoring ADR. By the end of 2002 ADR monitoring institutions at the provincial level and over 200 centers and stations below the provincial level for this purpose had been set up in 31 provinces, autonomous regions and municipalities directly under the central government. By then, a nationwide information network for monitoring ADR had emerged, making it possible for electronic reporting and online real-time reporting. Since 2000 China has made visible progress in ADR reporting. In 2007, some 400 cases of ADR per one million people were reported, a ratio approaching that of the developed countries. This demonstrated the considerable improvement in China's monitoring and early-warning capability regarding ADR. Drug administration departments promptly collect, evaluate and publish information about ADR. By the end of June, 2008, they had issued 13 bulletins in this respect, involving 44 types of drugs.
Meanwhile, drug administration departments have actively explored and enhanced drug re-evaluation work, and conducted pilot study, as well as retrospective study and surveys of the safety of drugs sold on the market. Through re-evaluation and study, the drug administration departments have revised the directions for puerarin, potassium de-hydroandrograpolide succinate and andrographolide sodium bisulfite injections, abolished the pharmaceutical standard for manchurian aristolochia stem, revoked the manufacturing permission for bimolane, and suspended the selling and use of certain other types of drugs.
The state has reinforced its endeavors to establish the monitoring and re-evaluation system for the adverse event of medical devices. In 2004 this work was inaugurated nationwide. By the end of 2006, 31 provinces, autonomous regions and municipalities directly under the central government had set up provincial institutions to monitor the adverse event of medical devices, and an organizational framework for this purpose began to take shape. Based on the results of monitoring and re-evaluation, drug administration departments revoked the registration certificates for polyacrylamide hydrogel, ordered the recall of extracorporeal circulation circuits, and had dialysis powder re-registered.
China has continuously intensified its supervision and post-market quality sampling of drugs to facilitate the steady improvement of drug quality and safety. In 2007 the state made an evaluation sampling program for 13,595 batches of TCM preparations, chemical drugs and biologicals, with an overall acceptance rate of98 percent. Of the sampling products, there were 7,398 batches of chemical drugs, 2,586 batches of antibiotics and 3,611 batches of Chinese patent medicines, with acceptance rates of 98 percent, 98.1 percent and 97.6 percent, respectively. The influenza vaccine sampled had shown 100-percent acceptance rates for two consecutive years. Drug administration departments ordered the recall or withdrawal from the market of unqualified drugs and medical devices, exercised administrative control over them, and disposed of them according to law. At the same time, the state also adopted a series of measures to crack down on the manufacturing of counterfeit and inferior drugs so as to ensure safe use of drugs by the people.
II. Drug Safety Supervision System and Legal System
For many years the Chinese government has been continuously improving its drug safety supervision system, its drug safety technical supporting system and related laws and regulations.
In 1998 the State Drug Administration was established, and the State Food and Drug Administration (SFDA) was founded on the basis of the former in 2003. The SFDA is in charge of administrative supervision and technical supervision over the research, production, distribution and use of drugs (including Chinese crude drugs, prepared slices of Chinese crude drugs, traditional Chinese medicine preparations, chemical drug substances and their preparations, antibiotics, biochemical drugs, radio-active pharmaceuticals, serum, vaccines, blood products and diagnostic agents) and medical devices. China has established drug regulatory departments under the unified leadership of the central government, with vertical management below the provincial level. By the end of2007, there had been 2,692 drug regulatory departments in China, including 31 at the provincial level, 339 at the municipal (prefecture) level and 2,321 at the county (county-level city) level (including districts and counties of municipalities directly under the central government); with more than 1,000 drug technical supervision organizations with 64,000 personnel in China. In the vast rural areas, drug safety coordinators and information specialists had been employed to ensure drug safety and promote the building of a drug safety supervision network. By the end of 2007, there had been more than 97,000 drug safety coordinators and more than 514,000 information specialists in rural areas. A total of 578,000 stations of rural drug regulatory network had been established.
The state has been steadily increasing its financial investment into drug safety supervision, with the emphasis on improving the drug safety testing level and ability, and providing technical support for the drug safety supervision work. National-level drug technical supervision organizations mainly include the National Institute for the Control of Pharmaceutical and Biological Products, Chinese Pharmacopoeia Commission, Center for Drug Evaluation, Center for Drug Certification, National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products, Center for Drug Re-evaluation, National Center for ADR Monitoring and Center for Medical Devices Evaluation. These organizations, all affiliated to SFDA, take the responsibility of routine testing, testing methodology research, conservation of breeds of experimental animals, standardization research, technical evaluation of registration applications and ADR monitoring. In addition, there are 19 national port institutes for drug control taking the responsibility of registration testing and port testing of import drugs; 33 provincial-level institutes for drug control in charge of sample testing, retesting, consigned drug testing, new drug registration testing and state-planned sample testing within their respective jurisdictions, as well as the drafting of national drug standards; 325 municipal (prefecture)-level institutes for drug control in charge of sample testing and consigned testing of drugs within their respective jurisdictions.
With respect to the supervision of medical devices, a technical testing system at both the national and provincial levels has taken initial shape. There are ten national-level centers for medical device quality testing, which take the responsibility of registration testing of domestic Class III medical devices and import medical devices, as well as sample testing for the quality of Chinese medical devices. There are 30 provincial-level medical device testing organizations, responsible for sample testing of medical devices within their respective jurisdictions, as well as the registration testing of some types of medical devices. There are nine medical device testing organizations established by specialized universities and research institutes. In addition, there are 22 medical device standardization technical committees for different fields of specialization.
China attaches great importance to the building of a legal system for drug safety supervision. In 1984 the Drug Administration Law of the People's Republic of China was adopted by the Standing Committee of the National People's Congress (NPC). For the first time, the research, production, selling and use of drugs were covered by legal stipulations, and the legal responsibility for the production and sale of counterfeit and inferior drugs was defined. This symbolizes that China's drug administration work is now managed in accordance with the law. This Law was revised in 2001 to unify drug standards and abolish regional standards; heighten the legal responsibility for the production and sale of counterfeit and inferior drugs; and define Good Manufacturing Practice (GMP) and Good Supply Practice (GSP) as legal requirements. The Drug Administration Law of the People's Republic of China and other relevant laws and regulations provide a legal guarantee for drug administration ensuring the drug quality and protecting people's legal rights of drug use.
So far, the State Council has promulgated 17 administrative regulations concerning drugs, including Special Rules on Strengthening the Supervision and Management of the Safety of Food and Other Products, Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, Regulations for the Control of Narcotic Drugs and Psychotropic Drugs, Measures for the Control of Radioactive Drugs, Regulations for the Control of Blood Products, Regulations for the Administration of Distribution of Vaccines and Vaccination, Anti-doping Regulations, Regulations for the Administration of Precursor Chemicals and Regulations for the Protection of Traditional Chinese Medicines.
According to the Drug Administration Law of the People's Republic of China, the national drug regulatory department has formulated 29 provisions, including Provisions for Drug Recall, Provisions for Drug Registration, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Provisions for the Drug Distribution Licenses, and Good Supply Practice (GSP). The state drug regulatory department has also jointly promulgated provisions with the health, industry and commerce, and customs authorities, including Provisions for ADR Reporting and Monitoring, Standards for the Examination and Publicizing of Drug Advertisements, Provisions for the Examination of Drug Advertisements, Provisions for the Import Drugs, and Provisions for the Import and Export of Protein Assimilation Preparations and Peptide Hormones (Provisional).
The Chinese government attaches great importance to the formulation of administrative regulations concerning medical devices. In 2000 the State Council promulgated the Regulations for the Supervision and Administration of Medical Devices. The state drug regulatory department has drawn up ten related regulations, including the Provisions for Medical Device Registration, Rules for Medical Device Classification, Provisions for Medical Device Standards, Provisions for Clinical Trials of Medical Devices, Good Manufacturing Practice (GMP) for Medical Devices, Provisions for Evaluation of the Quality System of Medical Device Manufacturers, and Provisions for Indications, Labels and Packaging Marks of Medical Devices. The state drug regulatory department has also promulgated, together with the industry and commerce departments, the Standards for the Examination of Medical Device Advertisement sand Provisions for the Examination of Medical Device Advertisements.
Moreover, China has established a national drug standard system based on the Chinese Pharmacopoeia and standards set by the State Food and Drug Administration. Drug standards and quality standards for some medical devices are compulsorily applied nationwide. There are more than 15,000 national drug standards in China; and 686 medical device standards, of which 155 are national standards and 531 are industrial standards.
As early as in 1953, the Chinese government published the Chinese Pharmacopoeia. It has so far gone through eight editions, with the 2005 edition being the current edition. The 2005 edition adopted considerably more drug varieties than before, with the application of more modern analysis technologies, and more emphasis is placed on drug safety parameters. Additions and revisions are made to the general rules, analysis and testing methods and guidelines in respect of preparations. There are 1,146 monographs in Volume I, including Chinese crude drugs, prepared slices of Chinese crude drugs, herbal oil, fats and extracts, and compound and single prescriptions; Volume II admits 1,967 chemical drugs, antibiotics, biochemicals, radioactive pharmaceuticals and pharmaceutical excipients; Volume III admits 101 biological products.
China attaches great importance to raising and unifying national drug standards, and encouraging enterprises to formulate and apply registration standards higher than the national standards. The relevant departments of the Chinese government are unifying and raising the current national drug standards by stages and in batches, so that the testing technology of national drug standards will eventually reach the international advanced level.
III. Policies and Measures Concerning Drug Safety Supervision
Based on its national conditions and learning from international advanced experience, China has formulated policies and measures concerning the improvement of drug safety, effectiveness and quality control, and established a regulatory system covering research, production, distribution and use of drugs.
Drug Market Access System
In order to guarantee drug safety from the source, China has adopted approval procedures and qualification system with regard to drug products, drug manufacturers and distributors, and related personnel.- Implementing drug registration. New drugs, generic drugs and imported drugs applied for marketing are subject to rigorous technical evaluation and administrative examination and approval. Within Chinese territory, only those who have obtained Drug Approval Number or Drug Registration Certificate for imported drugs are allowed to engage in drug production or sales. In accordance with research and technical requirements specified in drug applications, the national drug regulatory department has formulated, promulgated and implemented 54 technical research guidelines, and basically established a technical evaluation system for drug registration which conforms to China's conditions.
- Implementing a market access system for pharmaceutical enterprises. All enterprises that apply for drug manufacturing or distribution shall be subject to examination in terms of staff qualifications, factory environment, equipment and facilities, business site, storage conditions and organization of quality management. Production or sales licenses are granted only when enterprises meet the requirements. Since the adoption of the drug licensing system, Chinese drug regulatory departments have identified qualified pharmaceutical enterprises through regular inspections and re-issuing of certificates after examination. The same licensing system is carried out for the management of enterprises that produce drug substances. Only licensed enterprises are allowed to produce or deal in drug substances.
- Implementing batch release system for biological products. China conducts compulsory inspection and approval for each batch of biological products before the products leave the factories for marketing, or are imported. Items which fail the inspection or approval shall not be allowed to be marketed or imported. Since 2001, China has gradually implemented the batch release system for such biological products as vaccines, blood products and invitro diagnostic reagents used for blood screening tests. Since January 1, 2006, all preventative vaccine products have been subject to approval by this batch release system; starting from January 1, 2008, all blood products must be subject to the batch release system. This batch release system for biological products plays a vital role in controlling infectious diseases like AIDS, as well as in safeguarding the public health.- Implementing examination and approval system for drug packaging, labeling and insert sheet. Drug packaging, labeling and insert sheet are major ways for the public to obtain drug information. In China, packaging containers and materials that are in direct contact with drugs must meet the standards for drug use. Drug labels shall be printed on or attached to drug packaging and insert sheet shall be included. Drug regulatory departments shall archive review or record for drug packaging, labeling and insert sheet in accordance with the Provisions on the Administration of Drug Insert Sheet and Labeling.- Implementing a certification system for registered pharmacists. In order to guarantee the quality of drugs and improve pharmacy service, professionals in pharmaceutical enterprises are required to take qualification examinations, participate in continuous training and be registered. Since the implementation of the certification system for registered pharmacists, drug regulatory departments have established a number of agencies for the management of qualification examination and registration, improved continuous training, and a complete working system is almost formed. By the end of 2007, a total of 150,000 people in China had obtained pharmacist's qualifications.
Quality Control Practice
China practices a certification system for the quality control over drug research, manufacturing and distribution, aiming to tighten drug safety control in an all-round way.
- Promoting Good Laboratory Practice (GLP) certification for non-clinical drug research. To improve the quality of non-clinical drug research and ensure the authenticity, integrity and reliability of experimental data, China promulgated the Good Laboratory Practice (GLP) for Non-clinical Laboratory Studies in 1999, and began the work of GLP certification in April 2007. So far, a total of 27 non-clinical drug research institutions have obtained GLP certification. Starting from January 1, 2007, all non-clinical drug safety research must be carried out in GLP-certified laboratories in the case of the evaluation of new drugs, which include chemical drug substances and their preparations, and biological products not yet marketed in China; effective components and organs extracted from plants, animals and minerals as well as their preparations not yet sold on the domestic market; effective components extracted from traditional Chinese medicine (TCM) and natural medicines as well as their preparations, and TCM injections.
- Promoting Good Clinical Practice (GCP) certification for drug clinical trials. To ensure scientifically accurate reflection and reliability of results as well as test subjects' rights and interests during clinical trials, China promulgated the Good Clinical Practice (GCP) for pharmaceutical products in 1999, and began the work of GCP certification on March 1, 2004. By the end of 2007, a total of 178 institutions conducting clinical trials had obtained GCP certification. GCP certification has greatly improved the quality of drug clinical trials in China. Meanwhile, an increasing number of international multi-centered clinical trials are being carried out in China.- Implementing Good Manufacturing Practice (GMP) certification for pharmaceutical manufacturers. In order to bring drug manufacturing under control, in the late 1970s and early 1980s, China introduced the GMP concept, and promulgated the Good Manufacturing Practice for Pharmaceutical Products in 1988, and began to handle applications for GMP certification in 1995. The present GMP is the1998 revised edition. Based on its national conditions, and in light of different drug dosage forms, China has implemented GMP standards for pharmaceutical manufacturers step by step, completing GMP certification for manufacturers of blood products in 1998, for manufacturers of sterile powder for injections, sterile freeze-dried powder for injections, large-volume injections and gene engineering products in 2000, and for manufacturers of small-volume injections in 2002. The year 2004 saw the attainment of the goals for the manufacturing of chemical drug substances and all drug preparations according to GMP standards. Manufacturers which failed GMP certification were ordered to stop production. Since January 1, 2006, the goals for the manufacturing of biological invitro diagnostic reagents, medical gas and prepared slices of Chinese crude drugs according to GMP standards have been reached step by step. Through GMP certification, we have eliminated pharmaceutical enterprises which failed to meet GMP standards, improved quality management among enterprises, and promoted structural adjustment in the pharmaceutical industry.- Implementing Good Supply Practice (GSP) certification for the drugs distributions. In order to prevent factors that might damage quality at each link of drug distribution and eliminate relevant potential quality risks, China promulgated the Good Supply Practice for Pharmaceutical Products in 2000. The work of GSP certification has gone through three stages: launching certification experimental trials in 2001, handling applications in 2002, and organizing certification in 2003 by the drug regulatory departments in provinces, autonomous regions and municipalities directly under the central government. Through GSP certification, China's pharmaceutical distributors have made great progress in terms of their overall strength and business conditions, with some unqualified enterprises eliminated.
Drug Classification System
Since 1995 China has been working on a drug classification system. In 1999 the country promulgated the Measures for the Administration of Classification of Prescription and OTC Drugs (trial), gradually implementing the classification management between prescription and OTC drugs. In order to select, examine and approve OTC drug types as well as make necessary distinctions between some prescription and OTC drugs, China has successively publicized 4,610 types of OTC drugs, including Chinese patent medicines. China regulated the administration of OTC drugs, formulated a prototype manual for OTC drugs with detailed contents, and publicized a specific logo for OTC drugs. The drug regulatory departments have integrated the drug classification management with GSP certification for drug retailing enterprises, and promulgated regulations that prescription and OTC drugs must be displayed in separate shelves, no open-shelf self-service for prescription drugs, and classification management for pharmacies. In recent years, China has increasingly tightened its supervision of prescription drugs and the administration of advertisements for prescription drugs, and stopped the mass media carrying advertisements for prescription drugs. China has steadily promoted a management mode of selling prescription drugs only to people with doctor's prescriptions, and successively promulgated compulsory measures for the sale of 11 categories of prescription drugs, including injections, and antibacterial and hormone drugs that can be bought only with prescriptions. Through publicity and training, China has made efforts to increase people's awareness and understanding of the necessity of the drug classification system.
Regulation of Controlled Medicines
The Chinese government has always attached importance to the regulation of controlled medicines, such as narcotics and psychotropic substances, as well as precursor chemicals and stimulants, to prevent them from flowing into illicit channels. Assignatory to the 1961 Single Convention on Narcotic Drugs, 1971 Convention on Psychotropic Substances, UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, and International Convention Against Doping in Sport, China has formulated laws and regulations concerning narcotic drugs, psychotropic substances, precursor chemicals and stimulants, made a list of controlled medicines and further revised its contents, established a comprehensive supervision system in which related departments coordinate their efforts, and actively tighten control over controlled medicines. Over many years, China has regulated the production and circulation of narcotics, psychotropic substances and precursor chemicals, established a monitoring network to achieve proper supervision over the whereabouts and quantities of controlled medicines. It has also set up and improved a drug-abuse monitoring network to examine the details and trends of drug abuse, as well as to give pre-warnings in case of emergencies during the management of narcotics and psychotropic substances. In response to cases in recent years involving the traffic of caffeine, manufacturing of crystal methamphetamine (known as "ice") and ketamine abuse, China has organized specific inspections regarding caffeine markets, strengthened the supervision of ephedrine (the substance used to produce "ice"), and adjusted the list of narcotics and psychotropic substances by putting more relevant substances under controlled medicines list.
Regulation of Medical Devices
In 2000, China promulgated the Regulations for the Supervision and Administration of Medical Devices, and primarily established an administrative system focusing on pre-marketing product examination and approval, and post-marketing surveillance and vigilance, as well as the supervision of manufacturers. The scope of vigilance mainly covers adverse event monitoring, product re-evaluation, alert and recall. The supervision of manufacturers includes random checks, routine inspection, checks for specific items and examination of the quality management system. China implements a registration system for medical devices. Registration review includes product tests, clinical trials and on-site inspection of product quality management system. In accordance with the level of potential risks, medical devices are classified into three classes. Among which, Class III products refer to those which are implanted into the human body, or are used to support life, and pose a potential danger to the human body. Therefore, their safety and effectiveness must be rigorously brought under control. For domestic Class III medical devices and all classes of overseas medical devices, technical review for registration are carried out by the state evaluation institutions. Technical review for registration of Class I and II medical devices are conducted by provincial evaluation authorities. In accordance with the current Catalog of Medical Device Classification, 108 types of medical devices are grouped in Class I,
National Essential Medicine System
China regards a national essential medicine system as an important basis for guaranteeing the public's primary health care, and plays an active role in establishing and improving such a system. China has systematically selected essential medicines twice, and adjusted the list of essential medicines four times. The list covers both pharmaceutical products and TCM. In July 2006,China launched a project to list essential medicines in urban communities and rural areas, successively announcing the first list of essential medicines for urban communities and rural areas, a list of the first group of enterprises designated for the production of essential medicines and a list of the first group of medicines produced by designated manufacturers. In addition, the country implemented a system of setting separate prices for medicines produced by designated manufacturers, and guided pharmaceutical manufacturers to supply cheap, commonly used medicines to medical institutions in both urban communities and rural areas. Work related to the essential medicine system has played a positive role in meeting the public's demands for essential medicines, and providing guidance to the public for the rational use of medicines.
IV. Supervision of Traditional Chinese Medicine and Folk Medicine
Traditional Chinese medicine (TCM) and folk medicine are special characteristics and advantages of Chinese medical science, and also important parts of the splendid culture of the Chinese nation. So far, more than 9,000 kinds of TCM preparations have been approved by the state to be sold on the market, and about 58,000 approval numbers have been granted. In 2007, the industrial output value of TCM reached 177.2 billion yuan, accounting for 26.53 percent of the total pharmaceutical industrial output value. The Chinese government attaches great importance to TCM's role in the prevention and treatment of diseases, has drawn up a series of administrative regulations and policies, works constantly to improve the supervision of TCM, and promotes the steady improvement of the quality of TCM.
Constant improvement of the national TCM standards system. There are 7,014 national standards for TCM. Among them, the 2005 Pharmacopoeia of the People's Republic of China records 582 kinds of Chinese crude drugs, prepared slices of Chinese crude drugs, fats and extracts, as well as 564 kinds of TCM preparations. Standards made by the ministry and bureaus record 438 Chinese crude drugs and prepared slices of Chinese crude drugs, 4,690 TCM preparations, 308 crude folk drugs and 432 folk drug preparations. To ensure the safety and efficacy of TCM injections, and establish effective quality control methods, the state is enhancing the standardization of TCM injections. In 2000, the state launched the" Improvement of Quality Standards of TCM Injections with the Production Permission and Work on Fingerprints Chromatogram", and issued the Technological Requirements of Fingerprint Chromatogram Research of TCM Injections. At present, China is working hard to improve the safety and quality control and indices of 123 kinds of TCM injections sold on the market, fix the production areas of crude drugs of TCM injections, strictly control the quality of raw materials, intermediate products and finished products, and realize overall quality control for production and processing.
Adopting a TCM protection system. In 1992 the state issued the Regulations on the Protection of Traditional Chinese Medicines, to encourage research and development of TCM varieties for clinical practice, and exercise classified protection of TCM varieties withsteady quality and proved curative effects. The TCM protection system has promoted the improvement of the overall quality of TCM, and related scientific and technological advancement, and boosts intensive TCM production. By the end of 2007, there were 2,469 kinds of TCM varieties under state protection.
Enhancing the management of Chinese crude drugs. The quality of Chinese crude drugs decides the quality of prepared slices of Chinese crude drugs and TCM preparations. The state has adopted comprehensive measures to enhance the management of Chinese crude drugs, protect TCM germ plasm and genetic resources, strengthen the selection and breeding of good varieties, and improve the quality of TCM from its sources. TCM databases and germ plasm resource databanks have been initially established and researches are being conducted into the protection of rare and endangered TCM resources. Endangered species, such as rhinoceros horn and tiger bone, are banned from being used as TCM ingredients while rare TCM resources, including natural musk and natural bezoar, are used within limited areas. The state is also conducting researches to find alternatives for rare and endangered TCM resources. We have realized the artificial cultivation of the main raw materials of prepared slices of Chinese crude drugs and TCM preparations, and are steadily developing standardized planting and industrialized production. In 2002 the state enacted the Good Agricultural Practices for Chinese Crude Drugs (trial) (GAP). At present, GAP certification has been implemented all over the country on a trial basis. The drug administration departments conduct on-the-spot inspections of enterprises which have applied for GAP certification. By the end of 2007, a total of 48 enterprises had passed GAP certification.
Heightening the production standards of prepared slices of Chinese crude drugs. The preparing of prepared slices of Chinese crude drugs is a characteristic technology of TCM production with geographic differences. The quality standards of prepared slices of Chinese crude drugs are included in the Pharmacopoeia of the People's Republic of China, Preparation Standards for Chinese Crude Drugs of the People's Republic of China and local standards. Since 2004, GMP (Good Manufacturing Practice) certification has been introduced, facilitating the modernization of prepared slices of Chinese crude drugs. By the end of 2007, a total of 343 enterprises had passed GMP certification. And from January 1, 2008,all enterprises involved in processing prepared slices of Chinese crude drugs must comply with the GMP requirements.
V. International Exchanges and Cooperation in Drug Safety
The Chinese government attaches great importance to and actively participates in various international drug safety activities, constantly broadens the channels and scope of foreign exchanges and cooperation, and earnestly fulfils its international duties, playing a positive role in safeguarding the safe use of drugs by consumers all over the world.
The Chinese drug administration department is energetically conducting exchanges and cooperation with foreign countries. China has signed cooperative agreements and memorandums with the drug regulatory authorities of the United States, Canada, France, the United Kingdom, EU, Italy, Australia, Cuba, Brazil, South Korea, Singapore and Thailand. In 2007 China signed a cooperation agreement with the US on drugs and medical devices, setting up mechanism of meetings between senior officials of the drug regulatory authorities of the two countries, and enhancing the supervision over the export and import of raw pharmaceutical materials (active pharmaceutical ingredients), thus providing an effective solution to the quality safety problem of export and import drugs and medical devices. China has made significant achievements in cooperation regarding traditional medicine with the United States, Canada, France, EU, Italy, Australia, Singapore and Thailand. Twenty Chinese crude drugs are adopted in the French list of medicinal plants, seven standards for Chinese crude drugs are adopted in the French pharmacopoeia, and four standards in the European pharmacopoeia through French recommendation. China and Japan jointly conduct the projects of the Sino-Japanese Friendship Center for Safety Evaluation of Drugs, and has established the National Center for Safety Evaluation of Drugs (NCSED), which basically meets the GLP requirements. Through the mechanism of joint commissions on economy and trade, China, the United Kingdom and Russia work cooperatively in drug imports and exports, and market access, promoting the normal development of the pharmaceutical trade.
China actively consolidates and develops its cooperation with the World Health Organization (WHO). China has successively executed the planned programs of the WHO covering the establishment of a system of essential medicines, combating the production and sale of counterfeit drugs, supervision of the use of antibiotics, improvement of access to medicines, comparative studies of drug regulations, safety of biological products, and access to information about drugs, as well as programs such as ADR monitoring, GCP and training of GMP inspectors for vaccines. China energetically participates in various important drug-related activities organized by the WHO, conducting extensive exchanges in the field of quality standards. China is active in hosting various international conventions. Through exchanges and cooperation with international organizations, it is able to further understand the current situation and trend of international drug administration, and to draw advanced experience, playing a positive role in improving the level of supervision and involving in international coordination in this respect.
In recent years China has launched increasing non-governmental exchanges and cooperation initiatives concerning drugs with other countries and regions. China's National Institute for the Control of Pharmaceutical and Biological Products and the Chinese Pharmacopoeia Commission have signed cooperation memorandums with the United States Pharmacopoeia (USP) and European Pharmacopoeia Commission (EPC), and signed a cooperation agreement with the UK's National Institute for Biological Standards and Control (NIBSC). The China Center for International Pharmaceutical Exchanges has established relations of cooperation with non-governmental groups and academic organizations from over 20 countries and regions. The China Pharmaceutical Association sends a delegation to attend the World Pharmaceutical Conference every year, and has established regular contacts with the American Society of Health-System Pharmacists (ASHP) and the Pharmaceutical Society of Japan(PSJ). China also energetically conducts exchanges with international pharmaceutical associations, societies and chambers of commerce in China, promoting extensive exchanges and cooperation between Chinese and foreign pharmaceutical circles. The China Chamber of Commerce for Import & Export of Medicines & Health Products has established cooperative relations with government bodies and pharmaceutical organizations from more than 20 countries and regions, including Japan, Republic of Korea and Russia, accelerating the protection of intellectual property rights in drugs and initiating the self-disciplined management of drug import and export enterprises.
Through efforts over many years, China has made remarkable progress in the supervision over drug safety. However, as the largest developing country in the world, China is still facing many difficulties and problems in this regard. More efforts need to be made to adjust the structure of the drug industry, improve the mode of production, reform the drug-safety administration system, and improve the research and development and renovation capabilities of the drug industry, as well as the prevention and management of drug risks. The Chinese government determines to thoroughly implement the scientific outlook on development, to stick to a people-oriented approach, further strengthen drug safety work, and to speed up the improvement of the level of the health of the people. China will continue to strengthen international exchanges and cooperation in pharmaceutical field, and join hands with other countries to provide safe and effective and quality controllable drugs to consumers of various countries, making further contributions to the cause of human health. (From SFDA)