Application for License for Business Start of Drug Production Enterprises in Sha

[2008-12-23 16:54:10]

Processing Authority: Safety Control Office under Shanghai Food and Drug Administration

Processing Procedures:

1. Application for Business Start

1) Any and all of applicants shall represent the report of application for obtaining qualification of business start to Shanghai Food and Drug Administration. The report shall covers any and all of contents as follows:

a. the profile of the very applicant, including his name, the funding source, and the industry currently engaged;

b. the profile of the proposed enterprise, including its business name, economic nature, investment scale, proposed site, surrounding environment, infrastructure, proposed production verities, from of prepared drugs, equipments, production capacity and technique, quality standard, construction scheduling plan, the profiles of the key officers and technical personnel whereof;

c. the following materials shall be attached into the report of application, if any:

1. the (xerox copies of the) supporting documents for the qualification of the very applicant and the funding credit;

2. the (xerox copy of the) Notice of Pre-Approval of Business Name of the proposed enterprise issued by the competent industrial and commercial administration;

3. the (xerox copy of the) supporting document of right to use land or the lease contract of the proposed site;

4. the (xerox copy of the) document of approval issued by the competent government or department of the proposed site;

5. the (xerox copy of the) certification of new drugs, the document of clinic approval, or the contract for transfer of technology; and

6. the (xerox copy of the) certificate of approval of foreign capital investment or reply of approval by Shanghai Foreign Trade and Economic Cooperation Commission in case of foreign-funded enterprises.

2) Shanghai Food and Drug Administration shall, within 30 working days upon receipt of the complete materials necessary for such application and subject to the Pharmaceutical Administration Law of the People's Republic of China, Regulations of Implementation of Pharmaceutical Administration Law of the People's Republic of China, and Measures for Supervision and Administration of Drug Production, conduct the due review and make the decision of approving the incorporation preparation or not.

3) The applicant shall, upon obtaining the document of approval, complete the incorporation preparation in the approved tine. Shanghai Food and Drug Administration shall conduct the follow-up survey along the preparation of the enterprise that has obtained the said approval. Any alteration in contents of the very applicant's materials necessary for application during the process of the project construction shall be reported and subject to review and approval by Shanghai Food and Drug Administration.

2. Application for License of Drug Production

1) Any and all of applicants shall, upon completion of incorporation preparation of the proposed enterprise, apply to Shanghai Food and Drug Administration for inspection and present any and all of materials as follows:

a. the addresses of both production and registration, type of business, and legal representative whereof;

b. the organization chart whereof (indicating the functions and duties, inter-relationship, and leading officer of each department);

c. the resume, educational background, and certificate of the title of a technical or professional post of each legal representative and leading officer of each department whereof; the registration for each technical personnel, engineering personnel, or technical workers of pharmacy or other relevant majors certified according to law, indicating the affiliated department and positions; and the scale table of the advanced, intermediate, and primary technical personnel;

d. the drawings of surrounding environment, overall plane layout, storage plane layout, and quality inspection place plane layout;

e. the layout plan of production technique (including the locker room, washroom, passages of people and materials, and air brake, indicating the direction of people and materials flow and the grade of air cleanliness), the plane layout of air input, return, and exhaustion, and the technique equipments plane layout whereof;

f. the scope, form of prepared drugs, models, quality standard, and bases of the proposed production;

g. the technique flow chart for form of prepared drugs or varieties of the proposed production, indicating the main controlling points and items;

h. the briefing of the air cleaning system, water control system, and verification of key equipments; and checkout of production and test apparatus, instruments, weighing apparatus;

i. the catalogue of the major production equipments and test apparatus; and

j. the file directory of the production management and quality management whereof.

2) Shanghai Food and Drug Administration shall, within 30 working days upon receipt of the complete materials necessary for such application and subject to Article VIII under Pharmaceutical Administration Law of the People's Republic of China, and requirements related to institution and personnel, premises and facilities, equipments, sanitation under Regulations of Implementation of Pharmaceutical Administration Law of the People's Republic of China, organize inspection, and, in case of passing such inspection, issue the License of Drug Production.

3. Any and all of drug production enterprises newly incorporated by foreign investors or investors from areas of Hong Kong SAR, Macao SAR, or Taiwan shall be subject to the Regulations for Direction of Foreign Investment, Guiding Directory of Foreign Investment Industries, and other policies related to foreign investment used in medical industry.

4. Production of narcotics, psychotropic drugs, medical-use poisonous substances, radio-pharmaceuticals, and medicine-category chemicals that can be easily used for production of poison drugs shall be subject to any and all of applicable state laws and regulations.

5. Any and all of newly incorporated drug production enterprises shall, within 30 days upon obtaining the registered number of approval for drug production, apply for the drug GMP certification subject to the applicable regulations.

Processing Address: Room 1102, No. 189, Pu'an Road, Shanghai

Processing Basis: 1. Pharmaceutical Administration Law of the People's Republic of China ;

2. Regulations of Implementation of Pharmaceutical Administration Law of the People's Republic of China; and

3. Measures for Supervision and Administration of Drug Production (for trial implementation)

Contact Tel: 021-63879380

Processing Time: Mondays through Fridays: 9:00~11:30

Time Limit for Processing: In case of application for business start: within 30 working days upon receipt of the complete materials necessary for such application; and

In case of application for license: within 30 working days upon receipt of the complete materials necessary for such application

Qualified Application Subject:

Scope of Application:

Application for incorporation of enterprises engaging in drug production in Shanghai and for obtaining the License of Drug Production.

Qualifications/Prerequisites for Application:

(I) There are the technical personnel majoring in pharmacy, technical personnel majoring in engineering, and other relevant technical workers with the corresponding certified qualifications;

(II) There are the premises, facilities and sanitary environment corresponding to the drug production whereof;

(III) There are the institution, personnel and necessary instruments and apparatus that can ensure the quality management and inspection of drugs produced whereby;

(IV) There are regulations and rules that can assure the drug quality; and

(V) The drug industry development plan and industrial policy formulated by the state are complied.

Source: 上海市人民政府

Keywords:Quality Supervision

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