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.
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