Execution authority: Drug Safety Supervision Division of Shanghai Drug Administration

Application procedure:
Execution procedure: (I) Procedure for application for establishment
1) The applicant shall submit the application to Shanghai Drug Administration. The application shall contain following contents:
a. Basic information of the applicant, including name of applicant, source of capital and current industry engaged;
b. Basic information of the enterprise to be established, including name of enterprise, economic nature, scale of investment, location, surrounding environment, infrastructure, product types, drug types, equipment, production capacity, techniques, quality standard, construction schedule, and main responsible management and technical staff;
c. The application shall be attached with following materials:
1. Copy of qualification certificate and credit certificate of applicant;
2. Copy of "Notification on Approval of Preselected Enterprise Name" issued by the authority for industry and commerce;
3. Copy of certificate of land use or land lease contract of the location to be used;
4. Copy of approval documents issued by the local governmental or relevant departments in charge of the location of enterprise applied;

5. Copy of certificate or clinical approval of new drug and technology transfer contract;
6. Certificate of approval of foreign investment or approval document of Foreign Economic and Trade Commission, for foreign-capital enterprise.
2) Shanghai Drug Administration shall take examination as per "Pharmaceutical Administration Law of the People's Republic of China", "Regulations on Implementation of Pharmaceutical Administration Law of the People's Republic of China" and "Measures on Supervision of Drug Production" within 30 working days since receiving the complete application materials and make decision whether to approve the establishment.

3) The applicant shall finish the construction within the approved construction period since obtaining the approval document. Shanghai Drug Administration shall trace and inspect the construction process of the enterprise. During the construction period, should there be any change of the item against the content of application, the applicant shall report the change to Shanghai Drug Administration for approval.

2. Application for "License of Drug Production"
1) After the construction of the enterprise in application, the applicant shall apply to Shanghai Drug Administration for examination and approval, with submitting following materials:
a. Production location, registered address, type of enterprise and legal representative of the new enterprise;
b. Institutional framework chart of the new enterprise, with duty of department, correlation of departments and department heads specified;
c. Resume, certificate of education level and certificate of professional title of the legal representative and department head of the new enterprise, registration book of the professional technicians, engineers and technical workers with legal certificates and specialized in pharmacology or other relevant work (their departments and posts are defined respectively), and the statistic form of senior, medium and primary technicians.
d. Diagram of surrounding environment, total layout plan, storage layout plan and layout plan of quality inspection place of the new enterprise;
e. Layout plan for production process, including locker room, bathroom, walkway and materials path, gas valve, directions of walkway and materials path and clearness of air, layout plan of air purifying system, including air supply, air return and air exhaustion, and layout plan of technical equipments;
f. Scope of production, dosage form, type and quality standard;
g. Process chart for the dosage form or type to be produced, with the points and items in need of more quality control specified;
h. Verification result of air purifying system, water production system and other main equipments, and calibration result of production and inspection instruments, devices and measurers;
i. Catalogue of main production equipments and inspection devices;
j. Catalogue of production management and quality management documents of the new enterprise.
2) Shanghai Drug Administration shall organize an examination as per Article 8 of "Pharmaceutical Administration Law of the People's Republic of China" and the stipulations of "Regulations on Quality Management in Drug Production" on organization, staff, workshop and facilities, equipments and hygienic condition within 30 working days since receiving the complete materials for examination and approval. The Administration shall issue "License of Drug Production" to the applicant that is qualified to the examination.

3. The establishment of a new foreign-capital drug producing enterprise shall be governed by "Guidance to Orientation of Foreign Investment", "Instructive Catalogue of Industries Available for Foreign Investment" and the policies for usage of foreign investment in medical industry. This requirement is also applicable for the investor from Hong Kong, Macao and Taiwan.

4. The production of narcotic drugs, psychotropic drugs, medical toxic drugs, rediopharmaceuticals and the drugs easy for production of toxic chemicals shall be governed by relevant laws and regulations.
5. The new drug producing enterprise shall apply for the certification of GMP within 30 days since obtaining the drug approval number.
Standard and basis of charge:
Submitted to:
Execution address: Room 1102, 189 Pu'an Road, Shanghai
audituser：

Basis of execution: 1. "Pharmaceutical Administration Law of the People's Republic of China"

2. "Regulations on the Implementation of Pharmaceutical Administration Law of the People's Republic of China"

3. "Measures on Supervision of Drug Production (Trial)"

Contact phone: 021-63879380
Website:
Time of service: 9:00—11:30 am through Monday to Friday
Time limit: Application for establishment: within 30 working days since receiving the complete application materials

Application for license: within 30 working days since receiving the complete application materials

Applicant's qualification: Scope of application:

Application for establishment of new drug producing enterprise and the "License of Drug Production".

Preconditions of applicant:

(I) The professional technicians, engineers and technical workers with legal certificates and specialized in pharmacology or other relevant work;

(II) Proper workshops, facilities and hygienic condition for drug production;

(III) Organization, staff and necessary equipments to conduct quality management and quality inspection of the drugs produced;

(IV) Relevant regulations able to promise the quality of drugs;

(V) Conformity with national plan and industrial policies for medicine industry.