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In accordance with the relevant provisions of the Pharmaceutical Administration Law, the Regulation on the Implementation of the Pharmaceutical Administration Law, and the Measures for the Supervision and Administration of Pharmaceutical Production (Order No. 37 in 2002) of the former State Drug Administration, the drug administrations under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall examine the application documents, and make decisions on whether to approve the preparatory establishment of new pharmaceutical production enterprises in compliance with the development planning of pharmaceutical industry promulgated by the State and the industrial policies. In order to exercise administrative functions strictly according to law, strengthen the examination and approval administration of new pharmaceutical production enterprises, and prevent repeated construction, our bureau has convened several symposia on the examination and approval administration of new enterprises, and communicated with the comprehensive economic administration organ of the State. We hereby give our notice as follows with regard to strengthening the examination and approval administration of new pharmaceutical production enterprises: I. The food and drug administrations (or the drug administrations) of all provinces, autonomous regions and municipalities directly under the Central Government shall, in the process of approving new pharmaceutical production enterprises, unify their minds, enhance their understanding, build up their concept of taking the overall situation into consideration, accurately understand and grasp the development planning of pharmaceutical industry of the State and the industrial policies, carry out the examinations strictly, give reasonable guidance, and prevent repeated construction. II. Strict approval procedures shall be formulated to guarantee the scientific results, impartiality and objectivity of the examination and approval, and prevent randomness. Any drug administration at the provincial level shall, within 10 working days after approving the preparatory establishment of an enterprise, submit the approval documents and the application form for approval of preparatory establishment of the new pharmaceutical production enterprise (workshop) (please refer to Annex1) to the Department of Drug Safety and Inspections under the State Food and Drug Administration. The new pharmaceutical production enterprises whose preparatory establishment was approved form February 1, 2003 to the date of promulgation of the present Notice shall, before October 15, 2003, submit their respective application forms for approval of preparatory establishment of their enterprises or of their workshops to the Department of Drug Safety and Inspections under the State Food and Drug Administration. III. The new pharmaceutical production enterprises (including the enterprises producing prepared Chinese herbal medicine slices, medical oxygen or extracorporeal diagnostics reagent, whose preparatory establishment is approved as of the date of promulgation of the present Notice) shall, after completing the preparatory establishment, prepare for acceptance inspection strictly in accordance with Article 8 of the Pharmaceutical Administration Law and the relevant requirements in GMP. The enterprise inspected qualified shall be issued a "Pharmaceutical Production Permit", and shall obtain the GMP certificate within the time limit prescribed in Article 6 of the Regulation on the Implementation of Pharmaceutical Administration Law. IV. A pharmaceutical production enterprise that intends to divide some of its production workshops to form independent pharmaceutical production enterprises shall comply with the relevant provisions in the Measures for the Supervision and Administration of Pharmaceutical Production. V. In order to stop inferior repeated construction, prevent and control environmental pollution, quicken the paces of structural adjustment, and promote the upgrading of production process, equipment and products, the new pharmaceutical production enterprises shall meet the requirements in environmental protection laws and regulations of the State. Their projects may not contain the technological equipment or products enumerated in the "Catalogue of the Eliminated Laggard Production Capacities, Processes and Products" promulgated by the pharmaceutical administration organ of the State (please refer to Annex2). Otherwise, the food and drug administrations (or the drug administrations) of the provinces, autonomous regions and municipalities directly under the Central Government shall not approve the application for preparatory establishment. VI. In order to make the direction of foreign investment suitable for China's national economic and social development plan, no foreign-funded project of new pharmaceutical production enterprise shall violate the State's "Catalogue for the Prohibited Foreign Investment Industries" (please refer to Annex 3). Otherwise, the application of the enterprise for the preparatory establishment shall not be approved. VII. If a foreign-funded project of new pharmaceutical production enterprise contains any of the products enumerated in the "Catalogue for the Restricted Foreign Investment Industries" (please refer to Annex 4), the food and drug administration (drug administration) of the province, autonomous region or municipality directly under the Central Government shall examine it strictly in accordance with the Provisions on Guiding the Direction of Foreign Investment (Order No. 346 of the State Council) before granting the approval, and report to the State Food and Drug Administration for record. VIII. A pharmaceutical production enterprise that increases a production workshop or enlarges the production scope shall handle the matter by referring to the aforesaid relevant provisions. IX. The food and drug administrations (or the drug administrations) of all provinces, autonomous regions and municipalities directly under the Central Government shall pay close attention to the development planning and policies for the pharmaceutical industry and the relevant information promulgated by the comprehensive economic administration organ of the State, and shall strictly implement the industrial development planning and industrial policies of the State, so as to promote the healthy development of the medical industry. The opinions or suggestions put forward during the implementation of the present Notice shall be reported to the Department of Drug Safety and Inspections under the State Food and Drug Administration in time. Annexes: 1. Application Form for Approval of Preparatory Establishment of New Pharmaceutical Production Enterprise (Workshop) 2. Catalogue of the Eliminated Laggard Production Capacities, Processes and Products 3. Catalogue for the Prohibited Foreign Investment Industries 4. Catalogue for the Restricted Foreign Investment Industries Annex1กกกกกก APPLICATION FORM FOR APPROVAL OF PREPARATORY ESTABLISHMENT OF NEW PHARMACEUTICAL PRODUCTION ENTERPRISE (WORKSHOP) __________ Province (Autonomous Region or Municipality Directly under the Central Government) Name of the Enterprise (Workshop) to Be Established: Name of the Applicant: Address of the Enterprise (Workshop) to Be Established: Scope of Production: Medicine to Be Produced: Date of Acceptance: Date of Approval: Type of the Enterprise to Be Established: Industry to Which the Applicant Belongs Zip Code: Type of the Enterprise: Country or Region of the Foreign Party to the Foreign-Funded Enterprise: Legal Representative: -Professional Title: -Specialty: Responsible Person of the Enterprise: -Professional Title: -Specialty: Quality Responsible Person: -Professional Title: -Specialty: Production Responsible Person: -Professional Title: -Specialty: Contact Person: -Tel.: -Fax: Information on Construction of the Project -Construction Period (Years): -Estimated Fixed Assets Investments (ten thousand Yuan): --- Banking Loans (ten thousand Yuan): --- Foreign Investments (ten thousand Yuan): --- Self-raised Funds (ten thousand Yuan): --- Other Funds (ten thousand Yuan): -Annual Production Capacity: -Area of the Plant (Square Meters): -Construction Area (Square Meters) : ---For the Quality Inspection Department (Square Meters): Character of the Enterprise to Be Established and the Feasibility Demonstration: _____________(Date) __________ (Month) __________ (Year) (Official Seal) Instruction: 1. The medicines to be produced shall be listed in the attached table, including the names of the medicines, and the standardized basis, the new medicines, the imitation medicines, the registration schedule, etc. 2. Meanwhile, a schematic diagram on the plane layout of the enterprise to be established and a table of the main production equipment and testing apparatuses, including the names, types and the number, shall be attached. 3. Enterprise types: This column is to be filled in with medicinal chemicals, prepared traditional Chinese medicines, medicinal chemicals, prepared traditional Chinese medicines (and meanwhile the distillation from preparation, raw material medicines or traditional Chinese medicines shall be indicated in brackets); biotic products, extracorporeal diagnostics reagent, radioactive drugs, and others (prepared Chinese herbal medicine slices, medical auxiliary materials, hollow capsules, and medical oxygen). 4. Units for calculating the production capacity: ten thousand bottles, ten thousand pieces, ten thousand bags, tons, and so on. 5. The "Application Form for Approval of Preparatory Establishment of New Pharmaceutical Production Enterprise (Workshop) " shall be filled out in duplicates with accurate and entire contents as well as clear handwriting. Annex2: CATALOGUE OF THE ELIMINATED LAGGARD PRODUCTION CAPACITIES, PROCESSES AND PRODUCTS (FOR PHARMACEUTICAL INDUSTRY) I. LAGGARD PRODUCTION EQUIPMENT 1. Tower-type steam heavy distilling apparatuses 2. Hot-air driers without purification facilities 3. Ampoule filling and sealing machine 4. Handwork capsule filling 5. Cork wax packed medicine process II. LAGGARD PRODUCTS 1. Ampoule packed powder for injection 2. Antibiotics powder for injection packed with common natural rubber stopper (containing no Benzylpenicillin Sodium, Benzylpenicillin Potassium or Ampicillin for injection) 3. Lead and tin ointment pipe biotic products and blood products packed with common natural rubber stopper. Annex3: CATALOGUE FOR THE PROHIBITED FOREIGN INVESTMENT INDUSTRIES (FOR PHARMACEUTICAL INDUSTRY) 1. Processing of raw traditional Chinese medicinal materials listed in the State-preserved resources (musk, liquorice, ephedra, etc.) 2. Application of preparation processing of traditional prepared Chinese herbal medicine slices, and production of secret recipe products of prepared traditional Chinese medicines Annex4: CATALOGUE FOR THE RESTRICTED FOREIGN INVESTMENT INDUSTRIES (FOR PHARMACEUTICAL INDUSTRY) 1. Production of chloramphenicol, benzylpenicillin, lincomycin, gentamicin, dihydrostreptomycin, amikacin, tetracycline hydrochloride, terramycin, midecamycin, columnated crystal albomycin, ciprofloxacin, norfloxacin, and ofloxacin 2. Production of analgin, paracetamol, Vitamin B1, Vitamin B2, Vitamin C and Vitamin E 3. Production of vaccin and bacterin, and antitoxin and toxoid (bcg vaccine, vaccine of poliomyelitis, diphtheria tetanus and pertussis, measles, Encephalitis B, meningitis, etc.) under immunity plan of the State 4. Production of medicinal materials of addictive narcotics and psychotropic drugs (with shares controlled by the Chinese party) 5. Production of blood products 6. Production of non-self-destroyed one-off injectors, infusion sets, blood transfusion sets and blood bags |
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