封面图
正文内容
GMP是英文 GOOD MANUFACTURING PRACTICE 缩写，中文含义是“药品生产质量管理规范”。世界卫生组织将GMP定义为指导食物、药品、医疗产品生产和质量管理的法规。世界卫生组织于1975年11月正式公布GMP标准。
GMP is the abbreviation of GOOD MANUFACTURING PRACTICE in English, which means "Good Manufacturing Practice" in Chinese. The World Health Organization defines GMP as a regulation that guides the production and quality management of food, drugs and medical products. The World Health Organization officially published the GMP standard in November 1975.
随着GMP的发展，国际间实施了药品GMP认证。GMP提供了药品生产和质量管理的基本准则，药品生产符合GMP的要求，药品质量符合法定标准。中国卫生部于1995年7月11日下达卫药发（1995）第35号”关于开展药品GMP认证工作的通知”。药品GMP认证是国家依法对药品生产企业（车间）和药品品种实施GMP监督检查并取得认可的一种制度，是国际药品贸易和药品监督管理的重要内容，也是确保药品质量稳定性、安全性和性的一种科学的先进的管理手段。同年，成立中国药品认证委员会（china certification committee for drugs,缩写为cccd）。1998年国家药品监督管理局成立后，建立了国家药品监督管理局药品认证管理中心。自1998年7月1日起，未取得药品GMP认证证书的企业，卫生部不予受理生产新药的申请；批准新药的，只发给新药证书，不发给药品批准文号。严格新开办药品生产企业的审批，对未取得药品GMP认证证书的，不得发给《药品生产企业许可证》。
With the development of GMP, GMP certification has been implemented internationally. GMP provides the basic guidelines for drug production and quality management. Drug production meets the requirements of GMP, and drug quality meets the statutory standards. On July 11, 1995, the Ministry of Health of China issued WYF (1995) No. 35 "Notice on Carrying out GMP Certification". Drug GMP certification is a system that the state legally implements GMP supervision and inspection on drug manufacturers (workshops) and drug varieties and obtains approval. It is an important part of international drug trade and drug supervision and management, and also an advanced scientific management means to ensure the stability, safety and quality of drugs. In the same year, China Certification Committee for Drugs (cccd) was established. After the establishment of the State Drug Administration in 1998, the Drug Certification Administration Center of the State Drug Administration was established. Since July 1, 1998, the Ministry of Health will not accept the application for the production of new drugs for enterprises that have not obtained the GMP certificate; If a new drug is approved, only a new drug certificate will be issued, and no drug approval number will be issued. The examination and approval of newly established drug manufacturing enterprises shall be strictly enforced. Those who have not obtained the GMP certificate shall not be issued a Drug Manufacturing Enterprise License.
取得药品GMP认证证书的企业（车间），在申请生产新药时，药品监督管理部门予以优先受理：迄至1998年6月30日未取得药品GMP认证的企业（车间），药品监督管理部门将不再受理新药生产的申请。取得药品GMP认证证书的药品，在参与国际药品贸易时，可向国务院药品监督管理部门申请办理药品出口销售的证明：并可按国家有关药品价格管理的规定，向物价部门重新申请核定该药品价格。各级药品经营单位和医疗单位要优先采购、使用得药品GMP认证证书的药品和取得药品GMP认证证书的企业（车间）生产的药品。药品GMP认证的药品，可以在相应的药品广告宣传、药品包装和标签、说明书上使用认证标志。
When an enterprise (workshop) that has obtained a GMP certificate applies for the production of new drugs, the drug regulatory department will give priority to accepting the application. As of June 30, 1998, the drug regulatory department will no longer accept the application for the production of new drugs. When participating in the international drug trade, a drug that has obtained a GMP certificate may apply to the drug regulatory authority under the State Council for a certificate of drug export sales, and may reapply to the price department to verify the price of the drug in accordance with the provisions of the State on drug price control. Drug distributors and medical units at all levels shall give priority to purchasing and using drugs with GMP certificates and drugs produced by enterprises (workshops) with GMP certificates. For drugs certified by GMP, the certification mark can be used in the corresponding drug advertising, drug packaging and label, and instructions.
食品GMP认证由美国在60年代发起，当前除美国已立法强制实施食品GMP外，其他如日本、 加拿大、新加坡、德国、澳洲、中国等国家均尚采取劝导方式 辅导业者自动自发实施。
Food GMP certification was initiated by the United States in the 1960s. At present, except that the United States has legislated to enforce food GMP, other countries, such as Japan, Canada, Singapore, Germany, Australia, and China, still adopt the method of persuasion to guide the practitioners to implement it automatically and spontaneously.
我国目前医疗器械产业发展非常迅速，越来越多的产品进入市场，对医疗器械的安全性、 性提出了越来越高的要求。为此，加大监管力度，鼓励先进，淘汰落后是新 形势下的必然选择。通过推行医疗器械GMP，逐步提高准入门槛，在严格日常监 管、保障企业产品安全的同时，逐步淘汰一批散、乱、差，推动企业提升管 理水平，适应国际规则，使优秀企业做大做强。提升医疗器械生产管理标准与国 际接轨，是中国医疗器械企业立足于本土，积极走向世界的必由之路。
At present, China's medical device industry is developing very rapidly. More and more products are entering the market, which puts forward higher and higher requirements for the safety and performance of medical devices. Therefore, it is an inevitable choice under the new situation to strengthen supervision, encourage the advanced and eliminate the backward. Through the implementation of GMP for medical devices, we will gradually raise the threshold of access, and gradually eliminate a number of scattered, disordered, and poor enterprises while strict daily supervision and ensuring the product safety of enterprises. We will promote enterprises to improve their management level, adapt to international rules, and make outstanding enterprises bigger and stronger. Improving the production and management standards of medical devices in line with international standards is the only way for Chinese medical device enterprises to take a foothold in China and actively move towards the world.
医疗器械GMP自2011年1月1日 起正式实行，2011年7月1日后达不到规范的企业将不允许注册。
The GMP of medical devices has been officially implemented since January 1, 2011. Enterprises that fail to meet the specifications after July 1, 2011 will not be allowed to register.