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Temporary Regulation For The Establishment Of Drug Manufacturing Enterprises - 1999



Article 1: This Temporary Regulation is promulgated according to the Drug Administration Law and its rules for implementation, Document #53 [1994] issued by State Council, and the Document # 14 (1996) issued by the Office of the State Council in order to strengthen the administration by the State over drug production and to ensure the efficacy and safety of drugs.

Article 2: SDA is responsible for reviewing establishment qualifications and GMP certification for drug manufacturing enterprises.

Article 3: All newly established drug manufacturing enterprises in the PRC, including various forms of joint-operation enterprises, Chinese-foreign joint ventures, Chinese-foreign cooperative enterprises and wholly foreign-owned enterprises, should observe this Regulation.

Article 4: In order to apply to establish a new drug manufacturing enterprise, the company should have New Drug Certificates for drugs above Class 2 (including Class 2) which are not produced in China. In order to apply to establish a manufacturing enterprise for Chinese traditional medicines, the company should have two or more (including two) New Drug Certificates for drugs above Class 3. For a biologics manufacturing enterprise, the company should be in compliance with special requirements.

Article 5: In order to establish a drug manufacturing enterprise, the company should submit an application report to the provincial SDA departments. The application report should contain the following:

1) a brief introduction of the company and the qualification certificate of its legal person;

2) the name and address of the proposed enterprise;

3) the legal person of the proposed enterprise and the resumes for the key responsible persons;

4) the resumes of the main technicians for the proposed enterprise (including name, age, sex, education, previous employment and position in the proposed enterprise);

5) the source of capital, its composition and approval status of fixed assets for the proposed enterprise;

6) the name, production capacity and specification of the proposed products;

7) a comparison between the proposed products and the products of the same category and sales forecasts in domestic and foreign markets;

8) an introduction of the proposed industrial technology, its advantages and disadvantages and the source of the technology;

9) an explanation of proposed fuels, power, communication and transportation aspects;

10) the environmental impact and environmental protection measures of the proposed enterprise;

11) the number of staff and their education and technical background;

12) a list of the main manufacturing equipment;

13) a list of the main testing instruments;

14) the area needed for construction, diagram of total lay-out, production workshop technological process flow and technology layout diagram, location of production equipment, and indication of cleanliness grade;

15) a plan to implement the project.

Article 6: The application report to establish a drug manufacturing enterprise should have the following attachments (copies):

1) the approval documents from the responsible departments of the company which intends to establish the enterprise;

2) certificates of creditworthiness;

3) the land-use certificate or the lease contract for the construction site;

4) the valid approval documents for fixed assets investments;

5) new drug certificate, technology transfer contract or agreement;

6) certificates regarding basic production requirements, including water resources, quality of water, capacity of power, steam, and etc;

7) raw materials, strain of bacterium, source of industrial technology, and their certificates; and

8) other supplemental materials as determined by SDA.

Article 7: An application to establish a new foreign-invested drug manufacturing enterprise should be reviewed according to the "Temporary Regulation to Guide Foreign Investment", "Catalog Guide to Foreign Invested Industries" and the policies regarding utilizing foreign investment in the drug industry. The drug manufacturing enterprises operated by Hong Kong, Macao and Taiwan investors should also be reviewed according to these requirements.

For those projects in restricted categories of foreign investment, upon completion of the Project Proposal the application review shall be started; for those projects in permitted categories of foreign investment, the application review shall be started after completion of the Feasibility Study; for those projects in encouraged categories of foreign investment, the application review shall be started before the approval from the administrative departments of MOFTEC.

Article 8: The application materials should be accurate and true and, if necessary, be original documents. If fraud is discovered in any of the documentation, SDA has the right to cancel any approvals the company has received.

Article 9: After the preliminary approval from relevant provincial, autonomous region or, municipal city authorities, the application shall be submitted to SDA for review.

SDA shall make a decision whether or not to approve within 30 working days of receipt of the application materials.

Article 10: After receiving approval to begin operations, the new drug manufacturing enterprise shall entrust a qualified unit in drug engineering design for the design work. The project should be completed within two (2) years.

Article 11: After construction has been completed, the enterprise shall inspect itself according to GMP requirements. After review and approval from provincial SDA departments, the enterprise should apply to SDA for GMP examination. Upon meeting qualifications, the SDA will issue the "Drug GMP Certificate" and will notify the provincial SDAs to issue the "Drug Manufacturing Enterprise License" or handle any other modification procedures.

Article 12: For new construction, renovation and expansion of the workshops for existing drug manufacturing enterprises, the project proposal will be approved by provincial SDA departments and filed with SDA. For the new construction, renovation and expansion of the workshops for gene-engineering products, bacterium and vaccine, external immune diagnostic products, the project proposal should be submitted to SDA for approval. After completion of the new construction, renovation or expansion of the workshops, all other procedures should be handled according to Article 11 of this Regulation.

Article 13: Supplementary Provisions

1) The approval process for an application to establish a manufacturing enterprise for special drugs (narcotics, psychiatric drugs, toxic drugs and radioactive drugs), should be handled according to the current national laws for special drugs.

2) SDA is responsible for the interpretation of this Regulation.

3) This Regulation shall be implemented from the date of publication.

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