Pharmaceuticals Company incorporation in China
Last Updated: March 5, 2011
| FORM ID | 003 |
| More information of Company incorporation in China, check: | http://www.pathtochina.com/ |
Application requirements(conditions):
- The minimum registered capital:500,000RMB
- have practical registered address, the premise for business
- shall comply with the national and local statues and the foreign-invested industry policy.
- shall comply with the national economic and social development long-term planning, industrial planning, structure adjustment policies .
- shall comply with the public interest and the relevant provisions of the anti-monopoly
- shall comply with land-use planning, the overall urban planning and environmental protection policy requirements
- shall meet the states requirements of technical、arts and craft standard
- shall comply with the relevant provisions of state capital project management and the external debt management
- did not affect the city?economic and social security
- shall comply with foreign investment projects is a national restricted industries, shall provide inspectional advices of the industry sector
Application procedure and documents:
1. pre-approval of name of WFOE
Examination and Approval Department:
State Administration of Industry and Commerce (SAIC)
Time limit:
Within 5 working days
Required documents:
Pre-approval for names of enterprise
Appointment letter
2. Application for setting up WFOE
Examination and Approval Department:
State Development and Reform Commission
Time limit:
Within 20 working days
Required documents:
Application for project report
Identification of foreign investor (1、opening certificate、Identification of legal representative if the investor is a corporation ,including list of member of investor?shareholders、list of member of board of directors、resolution of represent authorized by the board of directors 2、copy of ID, if the investor is a person. The qualification certificate and identification shall be notarized by the national notary institution and authorized by the host country’s embassy (consulate))
Credit certificate of investor (issued by the bank)
Investment letter of intent
Other documents complied with the national and local statues and the foreign-invested industry policy.
3. the environmental assessment for establishment of enterprises
Examination and Approval Department:
State Environmental Protection Administration
Time limit:
30 working days after acceptance
Required documents:
The registration form for application of construction projects environmental management
Construction Project Environmental Impact registration form or construction project environmental impact reports (written), includes:
The preparation of environmental impact reports (written) are required to provide one written document and one electronic file
Project involves the construction of water and soil conservation, water also must have the Soil and Water Conservation Program the consented by the executive department
Environmental impact reports (written) shall meet demands of "on further standardize the work of the environmental impact assessment notice" (Central Office [2002] No. 88)
Project proposals and one approval document by relevant authorities (In accordance with relevant state regulations do not need to conduct a feasibility study , can be submitted only building project description)
Construction projects needed pre-trial by the industry sector in accordance with the law, shall hold the pre-trial opinion
Enterprise names pre-approved noticesM
Copies of certificates of title
Enterprises location map
Business establishments?floor plan.
State Development and Reform Commission
if the environment may cause significant impact and need to prepare environmental impact report and in accordance with the requirements construction projects which need to seek the views of residents around construction projects, are required to provide the results of verification meetings, hearings or other means to seek relevant units, experts of public opinion, but except confidentiality in accordance with the provisions.
4. GMP Certification
Examination and Approval Department:
The province State Drug Administration or above
Time limit:
State Environmental Protection Administration begin to approval procedure within 6 months
GMP certification procedures:
Article 1: enactment of this procedure in accordance with the spirit of other relevant documents notice State Drug Administration issued such as "Drugs GMP authentication management practices," enactment of this notification procedures.
Article II: Drug Administration is in charge of first-trail of application certification applied by GMP pharmaceutical production enterprises and gain "Drugs GMP certificate?and (workshop)day-to-day supervision and inspection work of enterprises (workshop).
Article 3: In the administrative area, offered by pharmaceutical production enterprises, including various forms of joint ventures, Sino-foreign cooperative business, Chinese-foreign joint ventures and WOFE, must comply with the procedural requirements.
Required documents:
"Drugs GMP certification applications" in duplicate,
"Pharmaceutical manufacturer’s license" and "business license" (photocopy);
Self-examination situation of Drug production management and quality management (including corporate overview and historical evolution of the situation, production and quality, correction situation of the previous certification defects project);
Production organization chart of Pharmaceutical production enterprises (workshop) (specify the name of every organizations department, their mutual relations, department heads)
photocopy of the resume 、certificate qualifications and titles of the legal representative、statutory agents, the responsible persons, head ; registration form of pharmacy and related professional and technical personnel, engineering technicians, skilled workers in accordance with the law and marked with the host departments and position; ratio form of High, intermediate and early the technical personnel.
Pharmaceuticals production enterprises surroundings map, the layout map, quality testing sites layout diagram;
General and pharmaceutical production plant layout of the floor plan (including changing rooms, toilet, and material flow channel, gas gate, and marked the air cleaner grade); The layout diagram of air supply air purification system, return air, exhaust Process equipment
dosage forms of application for certification or process diagram, indicate the main point of process control and control projects;
situations about the key processes of pharmaceuticals production enterprises (workshop), major equipment, water systems and air purification system certification and testing instruments, meters, weighing instrument calibration;
document directory of production management, quality management of pharmaceuticals production enterprises (workshop),;
new pharmaceutical production run enterprises (workshop) for GMP certification, in addition to submit the documents specified in Article 5, submitted the copy of the batch production records certification scope related the variation
5. Production licenses for drugs and medicines business license
Examination and Approval Department:
State Drug Administration
Time limit:
Within 30 working days
Required documents:
Registration form of Drugs production license
The basic situation of the applicant and its related documents
The basic situation of enterprises
Notice of Pre-approval for names of enterprise
The proposed organization chart of enterprises
photocopy of the resume 、certificate qualifications and titles of the legal representative、statutory agents, the responsible persons, head ; registration form of pharmacy and related professional and technical personnel, engineering technicians, skilled workers in accordance with the law and marked with the host departments and position; ratio form of High, intermediate and early the technical personnel.
Surrounding environment map, general layout plans, storage layout map, quality testing sites layout map of enterprises
The proposed layout of the floor plan in enterprise production process, the air supply air purification system, return air, exhaust layout diagram, process equipment layout plans
To produce varieties based on the quality standards and Formulations or varieties to the production process flow diagram, and indicate key points and project quality control
Major equipment and system verification profiles; the production, testing equipment, instruments, weighing instrument calibration
The main production equipment and testing equipment directory
The document directory of proposed enterprise production management, quality management,
Instrument of commitment of application materials authenticity of a statement of self-assurance, and materials to bear the legal responsibility
Authorized instructions
6. Application for setting up WFOE
Examination and Approval Department:
Municipal bureau of commerce
Time limit:
Within 7 working days
Required document:
Application for setting up WFOE
Feasibility report
Articles of association of proposed China company
Appointment letter of member of board of directors
Identification of member of board of directors
List of member of board of directors
Identification of foreign investor (1、opening certificate、Identification of legal representative if the investor is a corporation, including list of member of investor?shareholders、list of member of board of directors、resolution of represent authorized by the board of directors 2、copy of IC, if the investor is a person. The qualification certificate and identification shall be notarized by the national notary institution and authorized by the host country’s embassy (consulate))
Credit certificate of investor (issued by the bank)
Proof of the use of premises (including rental contract, proof of premises)
Notice for pre-approval name
4 x Letter of Authorization for legal documents service
Instrument of commitment
The copies of the IC and the power of attorney of the personnel
7. To process proposed agency code
Examination and Approval Department:
State Bureau of Technical Supervision (The Administration Center of Organization Code)
Time limit:
2 working days after acceptance
Required documents:
Approval of Articles of association of proposed China company
Application of proposed agency code
8. Industry and Commerce registrations of WFOE
Examination and Approval Department:
State Administration of Industry and Commerce (SAIC)
Time limit:
7 working days
Required document:
Application form of setting up WFOE
Articles of association of proposed China company
Approval by the approving authority and the copy of《Approval letter of foreign-invested enterprise》
2x Certificate of Incorporations or Equivalent document certified by Chinese embassy or Chinese consulate overseas. For individual investor: The passport copy of Investors need be certified by Chinese embassy or consulate.
2 x Bank reference letter
Company name application form, signed by investor.
4 x Letter of Authorization
Corporate secretary (contact) registration form
4 x Letter of Authorization for legal documents service
Besides, the printed name list of the investor, member of the board of director, general manager and supervisor, one copies each.
9. To record in Public Security Bureau
Examination and Approval Department:
Municipal Public Security Bureau (the administration center of embarkation and disembarkation)
Time limit:
6 working days
Required documents:
The registration application for record
The identification of legal representative
Business license, approval letter, photocopy of approval
10. To engrave of chop of enterprise
Examination and Approval Department
Engrave of chop organization proposed by police station
Time limit:
2 working days
Required document:
Application form of chop engrave
11. Apply code of enterprise
Examination and Approval Department:
State Bureau of Technical Supervision (The Administration Center of Organization Code)
Time limit:
3 working days after acceptance
Required materials:
Application form
Returning paper of proposed agency code
The identification of legal applicant
Business license, approval letter, photocopy of approval
12. Tax registration
Examination and Approval Department:
Municipal Local Taxation Bureau
Time limit:
5 working days
Required document:
Identification of legal representative
Business license, approval letter, photocopy of approval
Housing contract
Registration form of tax
13. Registration and Approval with State Administration of Foreign Exchange (SAFE):
State Administration of Foreign Exchange (SAFE)
Time limit for handing:
20 working days after acceptance
Required materials:
Written application (stamped by chop)
Copy of business license provided by the legal representative, non-legal representative enterprise shall provide original and photocopy of business license
Approval documents for approving the setting up of enterprise issued by the Commerce Department, the original and photocopy of the certificate.
Effective contract of foreign-invested enterprise (except for wholly-owned foreign enterprise), original Articles of association of proposed China company and its photocopy.
Original and photocopy of code of enterprise
14. Opening bank account
Due to the different requirement of the bank, the required documents need to be confirmed.
15. Financial registration
Examination and Approval Department:
The financial bureau
Time limit for handling
2 working days after acceptance
Required materials:
Business license, approval certificate, photocopy of approval
Financial registration form
16. Statistic registration
Examination and Approval Department:
The statistical bureau
Time limit for handling
2 working days after acceptance
Required materials:
Copy of Business license, approval certificate, photocopy of approval
Statistic registration form
17. Customs procedure to register WFOE
Examination and Approval Department:
Customs
Time limit
within 5 working day
Required documents:
Copy of Business license
Approval certificate, photocopy of approval
Photocopy of Articles of association of proposed China company photocopy.
Photocopy of tax registration
Photocopy of bank account certificate
Photocopy of certificate of proposed agency code
moulage of chop of enterprise、juridical person and apply to customs
Registration form for apply customs
Registration form of management for apply customs