Supervision And Administration Of Drug Production Methods

Original Language Title: 药品生产监督管理办法

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(August 5, 2004, the State food and drug administration released 14th come into force on the date of promulgation) 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.
    Second drug supervision and administration of production means (food) drug supervision and Management Department of the pharmaceutical production conditions and process reviews, management activities such as licensing, supervision and inspection.
    Third State food and drug administration responsible for supervision and administration of drug production nationwide; the provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments shall be responsible for the supervision and administration of drug production in the administrative area.
    Second chapter opened drug production enterprise of application and approval fourth article opened drug production enterprise, except should meet national developed of drug industry development planning and industry policy outside, also should meet following conditions: (a) has law after qualification finds of pharmacy technicians, and engineering technicians and the corresponding of technology workers, Enterprise statutory representative people or Enterprise head, and quality head no drug management method 76th article provides of case; (ii) has and its drug production phase adapted of plant, and facilities and health environment;
    (C) is able to produce medicines for quality management and quality inspection agencies, personnel and the necessary equipment and (iv) ensuring the quality of medicines regulations.
    Relevant State laws and regulations on the production of narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, pharmaceutical precursor chemicals such as otherwise provided, in accordance with its provisions.
    Fifth article opened drug production enterprise of applicants, should to proposed Enterprise location province, and autonomous regions, and municipalities (food) drug supervision management sector proposed application, and submitted following material: (a) applicants of basic situation and related proved file; (ii) proposed enterprise of basic situation, including proposed Enterprise name, and production varieties, and formulations, and equipment, and process and the production capacity; proposed enterprise of site, and around environment, and based facilities, conditions description and investment scale, situation description; (Three) business administration sector issued of proposed Enterprise name advance approved notice, production address and the registered address, and enterprise type, and statutory representative people or Enterprise head; (four) proposed enterprise of organization institutions figure (indicate the sector of duties and the mutual relationship, and sector head); (five) proposed enterprise of statutory representative people, and Enterprise 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; senior, and intermediate, and primary technicians of proportion situation table; (six) proposed enterprise of around environment figure, and total plane layout figure, and warehouse plane layout figure, and quality test places plane layout figure; (seven) 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;
    (Eight) intends production of range, and formulations, and varieties, and quality standard and the according to; (nine) intends production formulations and the varieties of process flowchart, and indicate main quality control points and project; (ten) air purification system, and business water system, and main equipment validation profile; production, and test instrument, and instrument, and weighing check situation; (11) main production equipment and the test instrument directory; (12) proposed enterprise production management, and quality management file directory.
    The applicant should be responsible for the authenticity of all of their application materials.
    Separation of the sixth drug-producing enterprises will be part of the workshop, formed an independent manufacturer, in accordance with this article fourth, fifth of the provisions of the pharmaceutical production license. Seventh article province, and autonomous regions, and municipalities (food) drug supervision management sector received application Hou, should according to following situation respectively made processing: (a) application matters law not belongs to this sector terms range of, should rates made not accepted of decided, and told applicants to about administrative organ application; (ii) application material exists can spot corrections of errors of, should allows application people spot corrections; (three) application material not complete or not meet form review requirements of,
    Shall, on the spot or issued to the applicant within 5 working days notice of the correct materials, at once inform all applicants need to supplement content, fails to inform the, shall be accepted as of the date of receipt of the application materials; (d) the application materials are complete and conform to the form request for review, or all the correct materials in accordance with requirements of the applicant, be admissible.
    Provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments to accept or not to accept an application for drug manufacturers to start, should accept the certificate with this sector special seal and the date of the notification of acceptance or of the rejection notice.
    Eighth of provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments shall within 30 working days from the date of receipt of the application, make a decision.
    Following a review in conformity with the provisions and approved, and from the approval date of the decision in writing within 10 working days of the drug manufacturing license does not meet the requirements, is not granted a written decision, and explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.
    Article new drug manufacturer, pharmaceutical production enterprises of new pharmaceutical production plant or released production forms, pharmaceutical production, shall prove file or with the date of approval for full production in the 30th, according to the corresponding provisions of the State food and Drug Administration (food) drug regulatory authority for certification of good manufacturing practices.
    Tenth of provinces, autonomous regions and municipalities (food) administrative organ of the pharmaceutical supervisory and administrative departments shall website publicity and office space to the application of pharmaceutical production license required conditions, procedures, deadlines, need to submit all materials catalog and application model.
    Provinces, autonomous regions and municipalities (food) issued by the drug regulatory agency of the pharmaceuticals production license related information, should be made public, the public right of access. 11th of provinces, autonomous regions and municipalities (food) pharmaceutical supervision and management departments of production enterprises to run when applying for a review, should be public approval process and the results.
    The applicant and interested parties to submit written views on matters directly related to the vital interests of State and to defend themselves. 12th article drug production Enterprise opened application directly involved applicants and others Zhijian major interests relationship of, province, and autonomous regions, and municipalities (food) drug supervision management sector should told applicants, and interest relationship people can in accordance with legal, and regulations and national food drug supervision authority of other provides enjoys application hearing of right; in on drug production Enterprise opened application for review Shi, province, and autonomous regions, and municipalities (food) drug supervision management sector think involved public interests of major license matters,
    Shall be announced to the public, and hold a hearing.
    Chapter III administration of drug production licenses the 13th article of the pharmaceuticals production license original and copy, copy of the original and has 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.
    (Food) license approved by the pharmaceutical supervisory and administrative departments: business, production, and the production range address.
    Corporate name, legal representative, registered address, type of business and other projects should be set out in the license issued by the administrative departments for industry and commerce related content.
    Enterprise name shall conform to the principles of pharmaceutical production enterprise management production addresses in accordance with pharmaceutical production address; license number and production in accordance with the provisions of the State food and drug administration methods and categories to fill out.
    15th the pharmaceutical production license change into licensing changes and change of registered particulars.
    License change refers to, and the production range, address changes.
    Change of registered particulars refer to matters referred to in paragraph II of this article 14th changes. 16th drug manufacturers change the drug production licenses, licensing matters, should be before the original license is changed on 30th, to the issuing authority has introduced the drug manufacturing license application.
    Without approval, and shall not alter the license. Original licensing authority shall, from the date of receipt of the enterprise change requests within 15 working days whether to approve the change in the decision.
    No change, and shall state the reasons in writing and inform the applicants have the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.
    Change scope of production or production, pharmaceutical producing enterprises shall be submitted in accordance with the provisions of the present article fifth involving changes of relevant material, and reported to the local provinces, autonomous regions and municipalities directly under the (food) review the drug regulatory agency decisions.
    Drug manufacturer according to pharmaceutical production license licensing matters after the change, it shall register with the Administrative Department for industry and commerce enterprises registration procedures. 17th pharmaceutical producing enterprises to change the registration of pharmaceutical production license shall be approved by the Administrative Department for industry and commerce in the 30th after the change, the original issuing authority for the pharmaceutical production license registration.
    License issuing authority shall receive the enterprise change requests within 15 working days from the date of change.
    18th the drug production licenses, change, original issuing authorities shall record changes in the pharmaceutical production license copy of content and timing, and in accordance with the changed content of the pharmaceutical production license issued by the original, recover the original drug manufacturing license original, changed the drug manufacturing license of the same.
    19th the pharmaceutical production license has expired, the need to continue the production of pharmaceuticals, pharmaceutical producing enterprises shall, before the expiry of 6 months, the original issuing authority for the renewal of the pharmaceuticals production license. Primary certification authority combines companies comply with laws and regulations, the good manufacturing practices and quality system, in accordance with this approach on the review of the procedures and requirements for drug manufacturers to start, in the drug production licenses, whether or not to grant the renewal before the expiry of the decision.
    Meet the renewal is granted, recover the original license and issue a new certificate not in conformity with the provisions and no replacement of the written decision and explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law; fails to make a decision, as agreed with the replacement, and go through the appropriate procedures.
    20th 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. Article 21st of the pharmaceutical production license missing, drug manufacturers should apply immediately to the issuing authority to reissue, and posted on the media specified in the original Licensing Office declared lost.
    Original issuing authority lost enterprises posted a statement after expiration of 1 month from the date of the original approval within 10 working days to reissue the drug manufacturing license.
    22nd no unit or individual shall forge, alter, buy, sell, lease, lend the drug manufacturing license. 23rd of provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall incorporate the drug manufacturing certificate issuance, renewal, modification, replacement, suspension, revocation, cancellation, cancellation, processing of, within 20 working days after the work is completed report to the State food and drug administration records.
    Recovered according to law, disallowance of the pharmaceuticals production license, certification authorities should be archived for 5 years.
    Fourth chapter 24th contract manufacturing of pharmaceuticals management pharmaceutical contract manufacturing clients should obtain the approval of the drug manufacturer.
    25th drug commissioned production of the Trustees shall be held and produce the drug production conditions of good manufacturing practice certification of pharmaceutical enterprises. Delegate to a 26th will be responsible for the quality of drug production and sales.
    Clients should be entrusted the production conditions, make a study of the production technology and quality control of status, shall provide the trustee with commissioned drug production technologies and quality documents, guidance and monitoring of the whole production process.
    Trustee shall, in accordance with the production of the good production practices and save all entrusted with the production of documents and records in accordance with regulations.
    27th delegate to produce the contract should be signed by both parties, shall contain the rights and obligations of the parties, and specifying both commissioned in drug production technology, quality control and other aspects of rights and obligations, and shall comply with the relevant national drug control laws and regulations.
    28th injections, biological products (exclude vaccine products, blood products) and medicines across the provinces, autonomous regions and municipalities directly under the OEM applications, responsible for receiving and approving by the State food and drug administration.
    Vaccine products, blood products, as well as other drugs prescribed by State food and Drug Administration may not authorize the production.
    Narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive pharmaceuticals, drug class, commissioned the production of precursor chemicals in accordance with the relevant laws and regulations.
    29th article 28th of other drugs herein OEM applications, under the seat of both provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and Administrative Department is responsible for receiving and approving. Article 30th commissioned production, under the direction of the State food and drug administration or the provinces, autonomous regions and municipalities directly under the (food) drug supervision and management departments to apply and submit application materials for the 34th article of the present measures.
    (Food) drug supervision and management departments in accordance with the measures provided for in seventh accepted.
    31st accepting applications (food) the pharmaceutical supervisory and administrative departments shall, within 20 working days from the date of acceptance, in accordance with the conditions provided for in this chapter to review applications for contract manufacturing of pharmaceuticals, and decisions did not take a decision within 20 working days, approved by the Department head, and can be extended by 10 working days and shall inform the client the reasons for the extension.
    Following a review in conformity with the provisions and approval and written approval decision within 10 working days from the date of making the principal issued a pharmaceutical contract manufacturing documents; do not meet requirements, notify the client in writing and state the reasons and informed of their right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.
    32nd pharmaceutical contract manufacturing documents validity period of not more than 2 years, and should not exceed the expiry date for the drug approval documents required.
    33rd a pharmaceutical contract manufacturing needs to continue commissioned production of the expiry of the approval, the principal shall, on the expiry of 30th, submitted in accordance with the provisions of this article 34th-related materials, go through formalities for extension.
    OEM contract, client shall promptly apply for cancellation of pharmaceutical contract manufacturing documents. 34th article drug delegate production application material project: (a) delegate party and trustee party of drug production license, and license copies; (ii) trustee party drug production quality management specification certification certificate copies; (three) delegate party on trustee party production and quality guarantee conditions of assessment situation; (four) delegate party intends delegate 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 the local provincial Institute for drug control issued three consecutive batches of product inspection report.
    Delegate production biological products of, its three batch samples by trustee party location provincial drug test by extraction, and sealed, by China drug biological products verification by is responsible for test and issued test report book; (eight) trustee party location province, and autonomous regions, and municipalities (food) drug supervision management sector organization on Enterprise technicians, plant, and facilities, and equipment, production conditions and capacity, and quality institutions, and detection equipment, quality guarantee system assessment of views.
    Drug delegate production extension application by need of application material project: (a) delegate party and trustee party of drug production license, and license copies; (ii) trustee party drug production quality management specification certification certificate copies; (three) last approved of drug delegate production documents copies; (four) last delegate production during, production, and quality situation of summary; (five) and last drug delegate production documents occurred changes of proved file. 35th 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 clearly indicate delegate name and registered address, consignee name and address.
    Article 36th (food) drug supervision and management departments of pharmaceutical contract manufacturing applications for review, shall be referred to the implementation of this approach tenth to 12th of the relevant provisions of chapter II. 37th delegate that accepts foreign pharmaceutical manufacturers of pharmaceutical producing enterprises in China of processing drugs should be within 30th of the signed OEM contract to the local provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments.
    The drug may not be processed by sales in China, the use, in any form.
    Article 38th of provinces, autonomous regions and municipalities directly under the (food), contract manufacturing of pharmaceuticals pharmaceutical supervisory and administrative departments shall be approved, the record reported that the State food and drug administration.
    The fifth chapter, supervision and inspection of the 39th of provinces, autonomous regions and municipalities (food) drug regulatory agency responsible for the administration of pharmaceutical production enterprises in supervision and inspection work shall establish supervision and inspection of operational mechanism and management system, clear city divided into districts (food) drug regulatory agencies, and county level (food) the duty of supervision and inspection of drug regulatory agencies.
    State food and Drug Administration directly to the manufacturer for inspection, and the provinces, autonomous regions and municipalities directly under the (food) supervision and inspection work and the drug regulatory agency certified by the manufacturers of the good production practices to implement and supervise the implementation of certification and inspection.
    40th supervision and inspection of the main content is a drug manufacturer to implement the relevant laws and regulations and the implementation of the good manufacturing practices, supervision and inspection, including the pharmaceutical production license renewal inspection, track of the good manufacturing practices inspections, daily supervision and inspection, and so on. 41st levels (food) the pharmaceutical supervisory and administrative departments monitoring and checking and screening programmes should be developed, clear criteria for checking record of on-site inspection, the results shall inform in writing the unit under inspection.
    Need corrective action should make rectification and reform period, and implement follow-up inspections. At the time of inspection, (food) the pharmaceutical supervisory and administrative departments shall assign two or more inspectors conducting supervision and inspection, inspectors to the units under inspection shall produce their certificates.
    (Food) staff aware of the drug regulatory agency of technical secrets of enterprises and business secrets shall be kept confidential.
    42nd article supervision check Shi, drug production enterprise should provides about situation and following material: (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) drug production enterprise accept supervision check and the rectification implementation situation;
    (E) failed drug quality bulletin announcements the rectification of; (vi) other necessary materials that prosecutors needed to review. After the inspection is complete, (food) in drug supervision and management in the pharmaceutical production license inspection of copies specified.
    Mainly record the following: (a) inspection findings, (ii) significant quality accident in the production of drugs, substandard drugs by drug quality bulletin notices and (iii) whether drug manufacturers have illegally produced, and investigate and deal with the situation. Article 43rd place above the county level (food) the pharmaceutical supervisory and administrative departments shall, in laws, rules and regulations gives permission, establish the administrative supervision of pharmaceutical production enterprises in archives.
    Regulatory documents pertaining to drug production, production supervision and inspection, product quality supervision, records and reports of bad behavior, and so on.
    44th (food) supervise and check the pharmaceutical supervisory and administrative departments shall be without prejudice to normal production activities of drug manufacturers, shall not solicit or accept a manufacturer's property, shall not seek other interests.
    45th individuals and organizations found that drug manufacturers for illegal production activities, the right to (food) the pharmaceutical supervisory and administrative departments, (food) the pharmaceutical supervisory and administrative departments shall promptly verify, process.
    46th head of pharmaceutical producing enterprises, and the production of quality change, should change after the 15th will changes resume and qualifications and other relevant information report of provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments for the record.
    47th manufacturer key production facility conditions and status changes, should be changed in the 30th seat of provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments, provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative department needed to be checked.
    48th article of major drug manufacturers drug quality accidents, must immediately report the location of provinces, autonomous regions, or municipalities directly under the (food) pharmaceutical supervisory and Administrative Department and other relevant departments, provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall, within 24 hours of reporting State food and drug administration.
    The 49th article of the People's Republic of China on administrative licensing law (hereinafter referred to as the administrative licensing law) 70th circumstances, the issuing authority shall repay the tax write-off pharmaceutical production license, and within 5 working days since the date of the cancellation notice about administration of industry and commerce, and announced to the public.
    The sixth chapter legal liability article 50th article 69th, one of the administrative licensing law, States or provinces, autonomous regions and municipalities directly under the food and Drug Administration (food) the pharmaceutical supervisory and administrative department according to the request of the interested party or ex officio, may revoke the drug manufacturing license.
    51st applicant to hide relevant information or provides false information to apply for the pharmaceutical production license, provinces, autonomous regions and municipalities (food) inadmissible or not to approve the drug regulatory agency, and give a warning, and will not be accepted within 1 year of its application.
    The applicant provides false materials or take other dishonest means to achieve a drug manufacturing license, provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall revoke the drug manufacturing license, and will not be accepted within 5 years of its application, and to a fine of up to 10,000 yuan and 30,000 yuan.
    52nd have not acquired the drug production licenses to produce, in accordance with the provisions of 73rd of the drug administration law are punished.
    53rd unauthorized commissioned or commissioned the production of pharmaceuticals, the principal and the trustee in accordance with the drug management law provides for punishment of the 74th.
    54th article drug production enterprise has following case one of of, (food) drug supervision management sector in accordance with drug management method 79th article of provides give punishment: (a) drug production enterprise not according to provides implementation drug production quality management specification of; (ii) opened drug production enterprise, and drug production enterprise new drug production workshop, and added production formulations, in drug management method implementation Ordinance sixth article provides of time within not through drug production quality management specification certification, still for production of.
    55th as supervision and inspection (including track inspection and supervision), drug manufacturers do not meet good manufacturing practices standard, original certification authority based on test results should be made of the good manufacturing practices of the certification decision. 56th article drug production enterprise has following case one of of, by location province, and autonomous regions, and municipalities (food) drug supervision management sector give warning, ordered deadline corrected; late not corrected of, can at 5000 Yuan above 10,000 yuan following of fine: (a) not according to provides handle drug production license registration matters change of; (ii) accept outside pharmaceutical manufacturers delegate in China territory processing drug, not according to provides for record of; (three) enterprise quality head, and production head occurred change,
    Failing to report and (iv) key production facilities and other conditions and status of companies change, is not in accordance with the provisions of the record, and (v) significant quality of failing to report the accident; (vi) supervision and inspection to conceal the situation, provides false materials or refuses to provide relevant material.
    57th article (food) drug supervision management sector violation provides, on not meet drug production quality management specification of to drug production quality management specification certification certificate or on made certification certificate of enterprise not according to provides perform track check of duties, on not meet certification conditions of enterprise not law ordered its corrected, on not meet statutory conditions of units to drug production license of, according to drug management method 94th article of provides processing.
    Article 58th in the implementation of the administrative license as provided herein in violation of relevant laws and regulations, in accordance with the relevant laws and regulations.
    The seventh chapter supplementary articles article 59th this approach by the State food and Drug Administration is responsible for the interpretation. 60th these measures come into force on the date of promulgation.
                                                                                                              On December 11, 2002, issued by the State Drug Administration measures for the supervision and administration of drug production (for trial implementation) repealed simultaneously.

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