(Released December 11, 2002, the State Drug Administration, 37th) Chapter I General provisions article to strengthen the supervision and administration of drug production, according to the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations (hereinafter referred to as the pharmaceutical administration law, the drug administration law implementing regulations), these measures are formulated. Article drugs production supervision and management refers to the pharmaceutical supervisory and administrative departments shall administer its drug production review and production process, licensing, certification, inspection, supervision and administration activities.
    Scope of these measures include the establishment of pharmaceutical production enterprise application and approval, pharmaceutical production license management, pharmaceutical contract manufacturing management and supervision management.
    Third national drug administration responsible for supervision and administration of drug production nationwide; the provinces, autonomous regions, municipalities directly under the food and Drug Administration is responsible for the supervision and administration of drug production within their respective administrative areas. Second chapter opened drug production enterprise of application and approval fourth article opened drug production enterprise should meet national released of drug industry development planning and industry policy, bid people should to proposed Enterprise location province, and autonomous regions, and municipalities drug supervision authority proposed preparation application, and submitted following information: (a) bid people of basic situation and related proved file; (ii) proposed enterprise of basic situation, including proposed Enterprise name, and intends built address; intends production varieties, and formulations, and equipment, and process and the production capacity
    ; Their corporate site, surrounding environment, infrastructure conditions, such as a description, and the scale of investment and construction schedule of the project, (iii) the province, autonomous region, or municipality directly under the administration of other relevant information as required by.
    The fifth province, autonomous region, or municipality directly under the supervisory authority shall, on receipt of the completed bid information within 30 working days of the date, according to the pharmaceutical administration law and the implementation of the pharmaceutical administration law review the Ordinance and the regulations, and make a decision on whether to agree to build.
    Provinces, autonomous regions and municipalities directly under the food and drug administration after approval and reported to the State Drug Administration. Sixth after the organizers agreed to build the approval document, should complete the preparation within the approval period.
    In the course of project construction bidding and bid information is changed, it must be reported to the original authority for examination and approval. Seventh article bid people completed preparation Hou, should to approved preparation sector application acceptance, and submitted following information: (a) business administration sector issued of proposed Enterprise name advance approved notice, production and the registered address, and enterprise type, and statutory representative people; (ii) proposed enterprise of organization institutions figure (indicate the sector of duties and the mutual relationship, and sector head); (three) proposed enterprise of head, and sector head resume, degree and titles certificate; law after qualification finds of Pharmacy and the related professional technicians, and Engineering technicians, and technology workers registration form, and marked where sector and the post; high, and in the, and primary technicians of proportion situation table; (four) proposed enterprise of around environment figure, and total plane layout figure, and warehouse plane layout figure, and quality test places plane layout figure; (five) proposed enterprise production process layout plane figure (including locker room, and toilet between, and people and logistics channel, and gas gate,, and marked people, and logistics to and air clean degrees grade), air purification system of sent wind, and return, and row wind plane layout figure,
    Process equipment plane layout figure; (six) intends production of range, and formulations, and varieties, and quality standard and the according to; (seven) intends production formulations or varieties of process flowchart, and indicate main quality control points and project; (eight) air purification system, and business water system, and main equipment validation profile; production, and test instrument, and instrument, and weighing check situation; (nine) main production equipment and the test instrument directory; (ten) proposed enterprise production management, and quality management file directory. The eighth province, autonomous region, or municipality directly under the administration shall on receipt of the application within 30 working days from the date of acceptance of complete information, in accordance with article eighth of the drug administration law of provisions and of the good manufacturing practices (hereinafter referred to as pharmaceutical GMP) relevant institutions and personnel, plant and acceptance requirements for facilities, equipment, health organizations.
    Acceptance, issue a production license.
    Nineth separation of pharmaceutical producing enterprises will be part of the workshop, formed an independent manufacturer, in accordance with the fourth through eighth, the provisions of these measures. The tenth pharmaceutical producing enterprises shall not share production and test facilities with other units.
    Under special circumstances, drug manufacturers share production and test facilities shall be according to the relevant provisions of the State food and drug administration, reported the local provinces, autonomous regions and municipalities directly under the food and Drug Administration for review and approval.
    11th production of narcotic drugs, psychotropic drugs, toxic for medical drugs, radioactive drugs, precursor chemicals in medicine, shall comply with the relevant laws and regulations and relevant regulations of the State, and according to the provisions of the relevant procedures. 12th new established manufacturer, pharmaceutical production enterprises new production range or pharmaceutical production enterprises, renovation, expansion of production, pharmaceutical production, shall prove file or with the date of approval for full production in the 30th, in accordance with the provisions of application of drug GMP certification.
    The specific measures shall be formulated separately by the State food and drug administration.
    Chapter III administration of drug production licenses the 13th article of the pharmaceuticals production license original and copy, and duplicate copies of the same legal effect, valid for 5 years.
    The pharmaceutical production license uniformly printed by the State food and drug administration. 14th the pharmaceutical production license shall include the permit number, business name, legal representative, heads of enterprises, types of enterprises, registered address, production, production scope, issuing authority, date of issuance, expiration and other projects. License approved by the pharmaceutical supervisory and administrative departments: business, production, and the production range address, term of validity.
    Corporate name, legal representative, registered address, type of business and other projects should be consistent with the license issued by the administrative departments for industry and commerce.
    Enterprise name shall conform to manufacturer category management principles address by drug production address; license number and scope in production according to the provisions of the State food and drug administration methods and categories to fill out.
    15th article drug production enterprise change drug production License license matters of, should by drug management method implementation Ordinance fourth article provides, in license matters occurred change 30th Qian, to original sent card organ application drug production license change registration, original sent card organ should since received enterprise change application and the full information of day up 15 days within made whether agreed change of decided.
    Drug manufacturers increased production or change of address of the scope, you should submit the relevant information in accordance with the measures provided for in seventh, and reported to the seat of the provincial, autonomous region, or municipality directly under the administration of examination and approval.
    Pharmaceutical production and enterprise changes its corporate name, legal representative, registered address, type of business and other matters, should be approved by the administrative departments for industry and commerce in the 30th after the change, the original issuing authority for the pharmaceutical production license registration, primary certification authority upon receipt of the enterprise change requests and complete information within 15 working days from the date of change. Adopt an annual inspection of the 16th article of the pharmaceuticals production license system.
    The provinces, autonomous regions, municipalities directly under the food and Drug Administration is responsible for the organization within the administrative area of the annual inspection of the pharmaceuticals production license. 17th pharmaceutical supervisory and administrative departments in charge of inspection should be receiving the complete inspection information within 20 working days to complete the annual review of the information and, if necessary, on-site inspections can be carried out.
    Inspection copies should be included in the pharmaceutical production license stated and as a basis for then reissue the drug manufacturing license.
    18th Article holds drug production license of drug production enterprise should by provides submitted following annual information: (a) enterprise production situation and quality management situation self-examination report; (ii) drug production license copy and license copies, drug production license matters changes and the approval situation; (three) enterprise organization institutions, and production and quality main management personnel and production, and test conditions of changes and the approval situation; (four) Enterprise accept supervision check and the rectification situation;
    (E) issuing authority needs to review additional information.
    The 19th article of the pharmaceutical production and expiry date of the license needed to continue to produce drugs, certified units shall, before the expiry of 6 months, in accordance with the relevant provisions of the seventh of these measures and of provinces, autonomous regions, municipalities directly under the food and Drug Administration asked to submit applications for renewal of the pharmaceuticals production license information.
    20th of provinces, autonomous regions, municipalities directly under the food and Drug Administration should reissue the drug manufacturing license application information, inspection and acceptance by Convention, qualified to issue a production license for the drug.
    21st manufacturer terminated production of pharmaceuticals or closed, by the original licensing authority for cancellation of the pharmaceuticals production license and notify the administration of industry and commerce. 22nd loss of the pharmaceuticals production license, certified units shall apply immediately to the issuing authority to reissue, and posted on the media specified in the original Licensing Office declared lost.
    After the original approval of the certification authority, replacement of the pharmaceutical production license.
    23rd no unit or individual shall forge, alter, buy, sell, lease, lend the drug manufacturing license.
    The 24th province, autonomous region, or municipality directly under the administration of the drug manufacturing license should be issued, alteration, inspection, change, cancellation, replacement, handle, handling within 30 working days of the completion of work reported that the State Drug Administration.
    Fourth chapter 25th contract manufacturing of pharmaceuticals management pharmaceutical contract manufacturing clients should obtain the approval of the drug manufacturer.
    Article 26th commissioned production of the Trustees shall be held consistent with the production of the drugs a pharmaceutical production license and certificate of pharmaceutical GMP, and is fitting in with the production of the drug production and quality assurance criteria. Delegate to a 27th will be responsible for the quality of drug production and sales.
    Principal trustee of production conditions, make a study of the production technology and quality management status; shall provide to the trustee a delegate drug production technologies and quality documents, guidance and monitoring of the whole production process.
    Trustees should be carried out according to the drug GMP production and requirements to keep all entrusted with the production of documents and records.
    28th commissioned the production of pharmaceuticals should be signed by both parties of the contract, should include the responsibilities of both parties, and specifies the respective products OEM technology, quality control and other responsibilities, and should comply with the relevant national drug control laws and regulations.
    29th pharmaceutical contract manufacturing, application and approval procedures: (a) the principal direction is located, autonomous region, or municipality directly under the administration of medicines a delegate submitted applications for production and complete information. (B) the province, autonomous region, municipality directly under the food and Drug Administration is responsible for organizing the assessment of fiduciary.
    Assessment should include the production and technical personnel, premises, facilities, equipment and other production conditions and capacities, as well as inspection bodies, test equipment and quality assurance system.
    (C) the province, autonomous region, or municipality directly under the supervisory authority shall, on receipt of the drugs from the enterprises entrust the production of applications and complete information within 30 working days after the examination, examination, State food and Drug Administration approval.
    (Iv) across provinces, autonomous regions and municipalities entrusted production, delegates should be referred to the province, autonomous region, or municipality directly under the administration of applications and related information submitted, principal of provinces, autonomous regions, municipalities directly under the supervisory authority shall, on receipt of the application within 10 working days after the signing, to transfer all the information where the trustee of provinces, autonomous regions, municipalities directly under the food and drug administration.
    Consignee location province, autonomous region, or municipality directly under the supervisory authority shall, within 20 working days after receipt of information under the second paragraph of this article (b) provides that complete the trustee's examination and signing, reported to the State food and Drug Administration approval. (E) the State drug authority shall, within 20 working days from the date of receipt of application materials according to the decision.
    In conformity with the provisions and to entrust the two sides issued a pharmaceutical contract manufacturing documents.
    Article 30th drug-commissioned production of documents relating to its period of not more than 2 years, and the term of validity shall not exceed the requirements for registration of pharmaceuticals.
    31st in a pharmaceutical contract manufacturing within the period of validity of the documents, the trustor may not entrust other companies produce the drug.
    The 32nd pharmaceutical contract manufacturing needs to continue commissioned production of the expiry of the approval, client shall according to the original examination and approval procedures for extension procedures.
    OEM contract is terminated, clients should be according to the original examination and approval procedures for cancellation procedures in a timely manner. 33rd article drug delegate production declared information project: (a) delegate party and trustee party of drug production license, and enterprise corporate license copies; (ii) trustee party drug GMP certificate copies; (three) delegate party on trustee party production and quality guarantee conditions of assessment situation; (four) delegate party production drug of approved proved file copies and attached quality standard, and production process, packaging, and label and using manual real sample; (five) delegate production drug intends used of packaging, and Labels and manual style and color (vi) OEM contracts; (g) entrusted to the provincial Institute for drug control of three consecutive batches inspection report.
    Three samples of the biological products by trustee provincial Institute for drug control extraction, sequestration, of pharmaceutical and biological products are responsible for the inspection and issue an inspection report. Article 34th delegate should be implementing national quality standards for drug production and drug quality standards, its formulation, processing, packing, labeling, instructions, approval number and so on should be identical to the original content.
    In commissioning the production of pharmaceutical packaging, labels and instructions, shall identify the client company name and registered address, consignee name and address.
    Article 35th of blood products, vaccines, products, as well as the State drug other drugs prescribed by the Board shall not delegate.
    The 36th article of narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive pharmaceuticals, drug class, commissioned the production of precursor chemicals according to the relevant State regulations. 37th commissioned pharmaceutical production enterprises and foreign pharmaceutical manufacturers in China for processing drugs, and are not used in domestic sales, to the Trustees apply to the local drug administration of provinces, autonomous regions.
    Comply with provisions of the provinces, autonomous regions and municipalities directly under the food and Drug Administration approval, and report to the State food and Drug Administration for record. Fifth chapter, supervision and inspection of the 38th province, autonomous region, or municipality directly under the supervisory authority responsible for the administration of pharmaceutical production enterprises in supervision and inspection work shall establish supervision and inspection of operational mechanism and management system, a clear duty of supervision and inspection.
    State Drug Administration needed organization to monitor the drug manufacturer directly to check.
    39th supervision and inspection of the main content is a drug manufacturer to implement the relevant laws and regulations and implementation of pharmaceutical GMP conditions, supervision and inspection, including the pharmaceutical production license renewal or implementation of annual on-site inspections, drug GMP track inspections, daily supervision and inspection, and so on.
    40th State Drug Administration Organization for certification by drug manufacturers drug GMP checks; a province, autonomous region, or municipality directly under the administration of certification by manufacturers and drug GMP implementation supervision and certification status.
    41st pharmaceutical supervisory and administrative departments when conducting supervision and inspection should be recorded on-site inspections, inspection results in writing inform the inspected units.
    42nd head of the drug-producing enterprise quality, production change, staff should be in the 15th after the change in resumes and qualifications related to report the province, autonomous region, or municipality directly under the administration of the record.
    43rd manufacturer key production facility conditions and drug GMP certification changes, should change in the 30th seat of provinces, autonomous regions and municipalities directly under the food and Drug Administration approval according to relevant regulation.
    44th article of major drug manufacturers drug quality accidents, must immediately report the location of provinces, autonomous regions, municipalities directly under the food and drug administration and relevant departments, provinces, autonomous regions, municipalities directly under the food and Drug Administration should be reported within 24 hours of the State Drug Administration.
    45th pharmaceutical producing enterprises according to the information submitted must be true and complete as provided herein, shall produce relevant supporting documents when necessary.
    46th as supervision and inspection (including track inspection and supervision), found that drug manufacturers do not comply with drug GMP requirements, by the original licensing authority according to the assessment results can make a rectification or revoke the drug GMP certification decision.
    47th pharmaceutical producing enterprises, one of the following circumstances, the local provinces, autonomous regions and municipalities directly under the food and Drug Administration warning, rectification.
    (A) not by provides time handle annual of; (ii) violation this approach 15th article subsection (three) paragraph provides of; (three) violation this approach 37th article provides of; (four) violation this approach 42nd article provides of; (five) violation this approach 43rd article provides of; (six) drug production enterprise occurred major drug quality accident not by provides report of.
    48th as supervision and inspection, found that drug manufacturers are not required to implement drug GMP, under the 79th of the drug administration law provides penalties.
    49th pharmaceutical supervisory and administrative department personnel who violate these rules, abuse of power, deception, negligence, according to the pharmaceutical administration law and the implementing regulations of the pharmaceutical administration law and relevant regulations.
    The sixth chapter supplementary articles article 50th in all provinces, autonomous regions, municipalities directly under the food and Drug Administration can be formulated in accordance with the measures specified.
                                                                                51st these measures shall come into effect on February 1, 2003.