Application for Registration of New Drugs in Shanghai Processing Authority: Drug

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

Processing Procedures:

1. Any and all of applicants shall, subject to the category of the newly developed drug and the applicable technical requirements, complete pre-production, fill in the Application Form for Drug Registration which can be downloaded from www.sda.gov.cn , and present the required materials for such application and the drug sample to Shanghai Food and Drug Administration.

2. Shanghai Food and Drug Administration will, upon passing the initial form review of the materials necessary for application, issue the Acknowledgement Form of Receipt of Materials for Registration of New Drug;

3. Shanghai Food and Drug Administration shall, within the required time frame upon receipt of the materials for application, organize and complete form review, inspection of source materials, filed survey and sampling, notify the Shanghai Institute of Drug Control to conduct sample inspection and review of quality standard, if necessary, and issue the corresponding opinion of review and report of survey.

4. Shanghai Institute of Drug Control shall, upon receipt of the notice of registration inspection, conduct the sample inspection and review of quality standard, present the report of inspection and opinion of review of quality standard to State Food and Drug Administration within the required time fame, and copy them to both Shanghai Food and Drug Administration and the very applicant.

5. Shanghai Food and Drug Administration shall, in case of passing review, report the materials necessary for application with the opinion of review to State Food and Drug Administration for final review and approval, and inform the very applicant of such reporting.

Charging Standard & Basis: Subject to the Notice on Adjustment of Charging Scale for Drug Review and Inspection under Ji Jia Ge (1995) No. 340 jointly issued by State Plan Commission and Ministry of Finance, the review charges for application for clinic research of new drugs or for certificate/production of new drugs shall be imposed. Follows are the detailed charging scale:

Category of New Drugs Clinic Research (in RMB) Certificate/Production of New Drug

Class I 2,500 4,300

Class II 2,500 4,300

Class III 2,500 3,500

Class IV 2,000 3,500

Class V 2,000 3,500

Charges for review of new drugs shall be imposed under the standard of taking one bulk drug or preparation as one type. In case of adding one specification, another 20% of the review charge shall be collected as per the corresponding category.

Processing Address: Room 1106, No. 189, Pu'an Road, Shanghai

Processing Basis: 1. Pharmaceutical Administration Law of the People's Republic of China under No. 45 Presidential Order of the People's Republic of China;

2. Regulations of Implementation of Pharmaceutical Administration Law of the People's Republic of China under No. 360 Order of State Council;

3. Measures for Administration of Drug Registration (for trial implementation) under No. 35 Order of State Food and Drug Administration; and

4. Notice on Adjustment of Charging Scale for drug Review and Inspection under Ji Jia Ge (1995) No. 340 jointly issued by State Plan Commission and Ministry of Finance.

Contact Tel: 63855666-142

Processing Time: Tuesdays or Thursdays: 9:00~11:30 and 13:30~17:30

Time Limit for Processing:

1. Shanghai Food and Drug Administration shall, within 5 working days upon receipt of the materials required for application in general case, arrange and carry out the field survey of development and/or production site and inspection of source materials;

2. Shanghai Food and Drug Administration shall, within 30 working days upon issue of the Acknowledgement Form of Receipt of Materials for Registration of New Drug in general case, complete the form review, review of source materials, field survey and sampling, notify the Shanghai Institute of Drug Control to conduct sample inspection and review of quality standard, if necessary, and issue the corresponding opinion of review and report of survey;

3. Shanghai Institute of Drug Control shall complete the sample inspection within 30 working days upon receipt of the notice of registration inspection and the sample drug, or 60 working days in case of the special drugs and vaccine category products, and complete the review of the quality standard within 60 working days, or 90 working days in case of the special drugs and vaccine category produces, if necessary; and

4. Procedures and time frame for review by State Food and Drug Administration shall be subject to the Measures for Administration of Drug Registration (for trial implementation).

Qualified Application Subject: Application by the production/research entity within the territory of Shanghai Municipality for registration of any traditional Chinese medicine that is never sold in the domestic market, new natural drug, new chemical drug, and new biological product, including application for clinic study of the new drug or certificate/production and sales in market of the new drug.

1. Any and all of corporate organizations legitimately registered in the Chinese territory can act as the drug registration applicants (hereinafter referred to as the applicants) to apply for clinic study or certificate of the very new drug.

2. Any and all of drug production enterprises holding the License of Drug Production and the certificate of the Drug Good Manufacture Practice (GMP) certification are entitled to apply for production of the new drug within the scope of the checked category of preparation;

3. Any newly incorporated drug production enterprise, the newly established workshop of the drug production enterprise, or newly added production preparation category without the certificate of Drug GMP certification, shall obtain such certification within the due course of time provided in Article VI under the Regulations of Implementation of Pharmaceutical Administration Law of the People's Republic of China, otherwise the registered number of approval for the very drug shall be annulled automatically and cancelled by State Food and Drug Administration.

Source: 上海市人民政府

Keywords:Quality Supervision

GACC Announcement No.56, 2014 on Cross-Border E-Commerce Trade Supervision (2014-08-05)
China Joint Announcement No.1851, 2014 on Precursor Chemicals “1-Phenyl-2-bromo-1-propanone” & “3-oxo-2-phenylbutyronitrile” Supervision (2014-06-24)
GACC Decree No.208 on Supervising Pingtan Experimental Area (2013-07-23)
Measuring Instrument Administration to be Strengthened (2009-12-17)
Chinese Insurance Regulator Stresses Supervision on Insurance Investment (2009-11-16)
Liu Mingkang: China and the US will Deepen Cooperation of Cross-border Supervisi (2009-08-04)
The National Standard for the General Rule for Enterprises Quality Credit Rating (2009-06-18)
Chinese Gov't Pledges Better Quality Supervision over Farm Products (2009-02-02)
Chinese Gov't Pledges Better Quality Supervision over Farm Products (2009-02-02)
[Imports Management ] General Administration of Quality Supervision, Inspection (2009-01-20)

Partners: China Customs | China Customs Statistics | China International E-Commerce | Customs-info