中华人民共和国药品管理法实施办法

es， medical treatment units or individuals with the necessary conditions are encouraged to engage in the research in and development of new medicines.

　　Article 16 Procedures for the examination and approval of new medicines shall be formulated by the administrative department of health under the State Council.

　　Article 17 Before a new medicine is put to clinical testing， the research and development unit of this medicine is required to submit an application together with the relevant data and samples in accordance with the provisions for the examination and approval of new medicines.

　　Article 18 Clinical testing or clinical verification of a newly developed medicine must be conducted in the medical treatment unit（s） approved by the administrative department of health at the level of the province， autonomous region or municipality directly under the Central Government.

　　Article 19 After new medicines have been clinically tested and verified and have passed the primary examination by the administrative departments of health at the level of the province， autonomous region or municipality directly under the Central Government， the research and development unit of these new medicines shall submit an application to the administrative department of health under the State Council for examination and approval and New Medicine Certificates shall be issued accordingly.

　　The administrative department of health under the State Council is required to call， at the earliest possible time， the Medicine Appraisal Committee to make technical appraisal of the newly developed medicine after the complete application materials are received. A decision must be made within two months of the technical appraisal.

　　Article 20 The administrative department of health under the State Council and those in the provinces， autonomous regions or municipalities directly under the Central Government may set up a Medicine Appraisal Committee which is composed of experts in medical science and pharmacology from medical treatment units， scientific research units， pharmaceutical factories and medical co

lleges.

　　Article 21 The clinical testing or clinical verification unit， the department to examine and approve the newly developed medicine and individuals so involved are required to keep confidential the relevant data， figures， production techniques provided by a unit or individual that has developed the new medicine.

　　Chapter V Registered Document of Approval for Medicines

　　Article 22 For the production of a new medicine， the production unit shall submit an application to the administrative department of health under the State Council for examination and approval upon which a Registered Document of Approval shall be issued to the unit. However， this does not apply to the production of traditional Chinese medicine in ready-to-use forms.

　　To produce a certain kind of medicine for which the state， the province， autonomous region or municipality directly under the Central Government has already set standards， the production unit is required to submit an application to the administrative department of health at the level of the province， autonomous region or municipality directly under the Central Government. After consulting the department in charge of the production and trading of pharmaceuticals at the same level， the administrative department of health shall make a decision on whether to issue the Registered Document of Approval to the unit. However， this does not apply to the production of traditional Chinese medicine in ready-to-use forms.

　　Article 23 When applying for a Registered Document of Approval for a medicine， the production unit must present testing samples and relevant data to the medicine inspection organ appointed by the administrative department of health at the level of the province， autonomous region or municipality directly under the Central Government. The medicine inspection organ is required to make a test report and refer it to the administrative department of health for examination and approval， which shall， within 30 days of receipt of the test report， make a decision on whether to issue the Registered Document of Approval to the unit.

　　Article 24 The Registered Document of Approval for a medicine is valid for 5 years， during which time no change of the registration number shall be allowed. The Registered Document of Approval of a medicine shall become invalid if the medicine has not been produced for 3 years.

　　Article 25 The administrative department of health under the State Council is required to organize investigations of medicines that have been approved for production. The Medicine Appraisal shall revoke the Registered Document of Approval if it discovers by appraisal that the medicine's curative effects are uncertain， that they produce serious adverse reactions， or that for other reasons they are harmful to people's health.

　　Chapter VI Administration of Pharmaceutical Production Enterprises

　　Article 26 The state shall practise The Norms For Quality Control of Medicine Production. The administrative department of health under the State Council shall formulate The Norms For Quality Control of Medicine Production and supervise the implementation thereof. The departments in charge of the production and trading of medicines may formulate specific rules to guide the gradual implementation of the Norms.

　　Article 27 All the newly built pharmaceutical factories and the extension or rebuilt workshops of the existing pharmaceutical factories are required to meet the requirements stipulated in the Norms For Quality Control of Medicine Production. The existing pharmaceutical enterprises are required to establish hygiene rules and regulations to ensure medicine quality and strive to meet all the requirements stipulated in the Norms For Quality Control of Medicine Production gradually and in a planned way.

　　Article 28 Pharmaceutical production enterprises shall be staffed with professional technical personnel and

skilled workers who must meet the following qualifications：

　　（1） a factory manager in charge of pharmaceutical production and quality control must be familiar with the techniques involved in pharmaceutical production；

　　（2） the post of the director in charge of pharmaceutical production technology and quality inspection shall be held respectively by a pharmaceutist， an assistant engineer or a herbdruggist， depending on the kind of medicine being produced；

　　（3） the responsible workshop technician is required to have an education of at least the technical school level and with 5 years or more production experience；

　　（4） the technical workers are required to go through technical training before they are allowed to operate independently；

　　（5） with respect to those pharmaceutical factories processing traditional Chinese medicines into ready-to-use forms， if they are unable to meet the requirements stated in Item 2 of Article 28 of these Measures， the relevant posts shall be held by Chinese medicinal herb personnel who are familiar with the properties of the herbal medicine processed， can appraise medicinal herbs and have a mastery of the production techniques.

　　These personnel must be examined by and registered with the administrative department of health above county level.

　　Article 29 Pharmaceutical enterprises are required to have factory premises， facilities and a sanitary environment to ensure the quality of the medicine. They must be kept clean and tidy. If they are engaged in the preparation of transfusion medicament and powdered injection， they must have ultra clean conditions and super clean environment.

　　Article 30 Pharmaceutical enterprises are required to have their own quality inspection organ and personnel， as well as necessary instrument and equipment to ensure the quality of their products.

　　Article 31 Traditional Chinese medicine factories （including those traditional Chinese medicine workshops in Western medicine factories） must not only meet the requirements stipulated in Articles 28， 29， 30 and 32 of these Measures but also abide by the following stipulations：

　　（1） Raw medicinal herbs must be pretreated by way of picking， sorting， washing and baking according to the relevant requirements.

　　（2） See to it that the processing of traditional Chinese medicine into ready-to-use forms （including batching， grinding and packaging） shall be done in an environment free from contamination.

　　（3） Traditional Chinese medicine technical personnel shall be put in charge of quality control of the Chinese medicine produced in the Western medicine factories.

　　Article 32 Medicines must be made in accordance with the verified standards and through the fixed technical processes. If a pharmaceutical factory intends to make any change in the production technique which may affect the quality of the medicine， it is required to submit an application to the administrative department of health at the level of the province， autonomous region or municipality directly under the Central Government for examination and approval.

　　Article 33 Pharmaceutical enterprises are required to have a complete production record and lab testing record on file. These records shall be kept for one year after the expiry date of the recorded batch of medicine. With respect to medicines without expiry dates， their records shall be kept for 3 years.

　　Article 34 It is required that all raw materials and additives needed in the production of medicines， the containers and packaging material that may directly contact the medicine must meet the requirements of the sta

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