ess, the licenseit is holding should be cancelled by the administrative department ofhealth that has issued it.Article 14Pharmaceutical Producer Licence, Pharmaceutical Trading EnterpriseLicence, and Dispensing Permit shall be printed exclusively by theadministrative department of health under the State Council.
【章名】Chapter IV Examination and Approval of New Medicines
Article 15The state encourages research in and development of new medicines. Allpharmaceutical research units, medical colleges, pharmaceutical productionenterprises, medical treatment units or individuals with the necessaryconditions are encouraged to engage in the research in and development ofnew medicines.Article 16Procedures for the examination and approval of new medicines shall beformulated by the administrative department of health under the StateCouncil.Article 17Before a new medicine is put to clinical testing, the research anddevelopment unit of this medicine is required to submit an applicationtogether with the relevant data and samples in accordance with theprovisions for the examination and approval of new medicines.Article 18Clinical testing or clinical verification of a newly developed medicinemust be conducted in the medical treatment unit(s) approved by theadministrative department of health at the level of the province,autonomous region or municipality directly under the Central Government.Article 19After new medicines have been clinically tested and verified and havepassed the primary examination by the administrative departments of healthat the level of the province, autonomous region or municipality directlyunder the Central Government, the research and development unit of thesenew medicines shall submit an application to the administrative departmentof health under the State Council for examination and approval and NewMedicine Certificates shall be issued accordingly.The administrative department of health under the State Council isrequired to call, at the earliest possible time, the Medicine AppraisalCommittee to make technical appraisal of the newly developed medicineafter the complete application materials are received. A decision must bemade within two months of the technical appraisal.Article 20The administrative department of health under the State Council and thosein the provinces, autonomous regions or municipalities directly under theCentral Government may set up a Medicine Appraisal Committee which iscomposed of experts in medical science and pharmacology from medicaltreatment units, scientific research units, pharmaceutical factories andmedical colleges.
Article 21The clinical testing or clinical verification unit, the department toexamine and approve the newly developed medicine and individuals soinvolved are required to keep confidential the relevant data, figures,production techniques provided by a unit or individual that has developedthe new medicine.
【章名】Chapter V Registered Document of Approval for Medicines
Article 22For the production of a new medicine, the production unit shall submit anapplication to the administrative department of health under the StateCouncil for examination and approval upon which a Registered Document ofApproval shall be issued to the unit. However, this does not apply to theproduction 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 Governmenthas already set standards, the production unit is required to submit anapplication to the administrative department of health at the level of theprovince, autonomous region or municipality directly under the CentralGovernment. After consulting the department in charge of the productionand trading of pharmaceuticals at the same level, the administrativedepartment of health shall make a decision on whether to issue theRegistered Document of Approval to the unit. However, this does not applyto the production of traditional Chinese medicine in ready-to-use forms.Article 23When applying for a Registered Document of Approval for a medicine, theproduction unit must present testing samples and relevant data to themedicine inspection organ appointed by the administrative department ofhealth at the level of the province, autonomous region or municipalitydirectly under the Central Government. The medicine inspection organ isrequired to make a test report and refer it to the administrativedepartment of health for examination and approval, which shall, within 30days of receipt of the test report, make a decision on whether to issuethe Registered Document of Approval to the unit.Article 24The 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 ifthe medicine has not been produced for 3 years.Article 25The administrative department of health under the State Council isrequired to organize investigations of medicines that have been approvedfor production. The Medicine Appraisal shall revoke the RegisteredDocument of Approval if it discovers by appraisal that the medicine'scurative effects are uncertain, that they produce serious adversereactions, or that for other reasons they are harmful to people's health.
【章名】Chapter VI Administration of Pharmaceutical Production Enterprises
Article 26The state shall practise The Norms For Quality Control of MedicineProduction. The administrative department of health under the StateCouncil shall formulate The Norms For Quality Control of MedicineProduction and supervise the implementation thereof. The departments incharge of the production and trading of medicines may formulate specificrules to guide the gradual implementation of the Norms.Article 27All the newly built pharmaceutical factories and the extension or rebuiltworkshops of the existing pharmaceutical factories are required to meetthe requirements stipulated in the Norms For Quality Control of MedicineProduction. The existing pharmaceutical enterprises are required toestablish hygiene rules and regulations to ensure medicine quality andstrive to meet all the requirements stipulated in the Norms For QualityControl of Medicine Production gradually and in a planned way.Article 28Pharmaceutical production enterprises shall be staffed with professionaltechnical personnel and skilled workers who must meet the followingqualifications:(1) a factory manager in charge of pharmaceutical production and qualitycontrol must be familiar with the techniques involved in pharmaceuticalproduction;(2) the post of the director in charge of pharmaceutical productiontechnology and quality inspection shall be held respectively by apharmaceutist, an assistant engineer or a herbdruggist, depending on thekind of medicine being produced;(3) the responsible workshop technician is required to have an educationof at least the technical school level and with 5 years or more productionexperience;(4) the technical workers are required to go through technical trainingbefore they are allowed to operate independently;(5) with respect to those pharmaceutical factories processing traditionalChinese medicines into ready-to-use forms, if they are unable to meet therequirements stated in Item 2 of Article 28 of these Measures, therelevant posts shall be held by Chinese medicinal herb personnel who arefamiliar with the properties of the herbal medicine processed, canappraise medicinal herbs and have a mastery of the production techniques.These personnel must be examined by and registered with the administrativedepartment of health above county level.Article 29Pharmaceutical enterprises are required to have factory premises,facilities and a sanitary environment to ensure the quality of themedicine. They must be kept clean and tidy. If they are engaged in thepreparation of transfusion medicament and powdered injection,