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Application for License for First Review of Drug Production on Commission in Sha
[2008-12-23 16:54:10]
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Processing Authority: Safety Control Office under
Shanghai Food and Drug Administration
Processing Procedures: (I) Application 1 In case both entrusting and entrusted parties are the drug production enterprises in Shanghai: The very entrusting party shall present any and all of following materials to Shanghai Food and Drug Administration: (1) the report of application; (2) the Application Form of Drug Production on Commission in triplicate; (3) the xerox copies of the Licenses of Drug Production and Business Licenses of Incorporated Enterprise of both entrusting party and entrusted party; (4) the xerox copy of the Certificate of Drug GMP of the trusted party; (5) the assessment of conditions assuring production and quality of the entrusted party by the entrusting party; (6) the xerox copy of the supporting document of approval of the drug production of the entrusting party attached with the quality standard, production technique, packaging, label, and the single pattern of the specification; (7) the proposed packaging, label, pattern of specification, and colour code of the drug produced on commission; (8) the contract for production on commission; and (9) the report of inspection for the straight three batches of products by Shanghai Institute for Drug Control. 2 In case the entrusting party is the drug production enterprise in Shanghai, and the entrusted party is the drug production enterprise in other province, autonomous region or municipality of China: The very entrusting party shall present any and all of following materials to Shanghai Food and Drug Administration: (1) the report of application in writing; (2) the Application Form of Drug Production on Commission in triplicate; (3) the xerox copies of the Licenses of Drug Production and Business Licenses of Incorporated Enterprise of both entrusting party and entrusted party; (4) the xerox copy of the Certificate of Drug GMP of the trusted party; (5) the assessment of conditions assuring production and quality of the entrusted party by the entrusting party; (6) the xerox copy of the supporting document of approval of the drug production of the entrusting party attached with the quality standard, production technique, packaging, label, and the single pattern of the specification; (7) the proposed packaging, label, pattern of specification, and colour code of the drug produced on commission; (8) the contract for production on commission; and (9) the report of inspection for the straight three batches of products by the institute for drug control at the provincial level. 3 In case the entrusting party is the drug production enterprise in other province, autonomous region or municipality of China, and the entrusted party is the drug production enterprise in Shanghai: Any and all of following materials shall be presented to Shanghai Food and Drug Administration by the food and drug administration of the other province, autonomous region or municipality of China which governs the entrusting party: (1) the report of application in writing by the entrusting party to the competent local food and drug administration which governs the place where the entrusting party is located; (2) the Application Form of Drug Production on Commission in triplicate; (3) the xerox copies of the Licenses of Drug Production and Business Licenses of Incorporated Enterprise of both entrusting party and entrusted party; (4) the xerox copy of the Certificate of Drug GMP of the trusted party; (5) the assessment of conditions assuring production and quality of the entrusted party by the entrusting party; (6) the xerox copy of the supporting document of approval of the drug production of the entrusting party attached with the quality standard, production technique, packaging, label, and the single pattern of the specification; (7) the proposed packaging, label, pattern of specification, and colour code of the drug produced on commission; (8) the contract for production on commission; and (9) the report of inspection for the straight three batches of products by Shanghai Institute for Drug Control. (II) Review 1 In case both entrusting and entrusted parties are the drug production enterprises in Shanghai: Shanghai Food and Drug Administration shall, within 30 working days upon receipt of materials necessary for application for drug production on commission presented by the very enterprise, complete the due review and assessment, bring out the opinion of the first review, and report to State Food and Drug Administration for final review and approval. 2 In case the entrusting party is the drug production enterprise in Shanghai, and the entrusted party is the drug production enterprise in other province, autonomous region or municipality of China: Shanghai Food and Drug Administration shall, within 10 working days upon receipt of materials necessary for application for drug production on commission presented by the very enterprise, bring out the opinion of the first review, and forward them to the competent food and drug administration at the provincial/autonomous region's/municipal level which governs the place where the entrusted party is located. 3 In case the entrusting party is the drug production enterprise in other province, autonomous region or municipality of China, and the entrusted party is the drug production enterprise in Shanghai: Shanghai Food and Drug Administration shall, within 20 working days upon receipt of materials necessary for application for drug production on commission forwarded by the competent food and drug administration at the provincial/autonomous region's/municipal level which governs the place where the entrusting party is located, complete the due review and assessment, bring out the opinion of the first review, and report to State Food and Drug Administration for final review and approval. 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 both entrusting and entrusted parties are the drug production enterprises in Shanghai: within 30 working days for the first review; In case the entrusting party is the drug production enterprise in Shanghai, and the entrusted party is the drug production enterprise in other province, autonomous region or municipality of China: within 10 working days for the first review; and In case the entrusting party is the drug production enterprise in other province, autonomous region or municipality of China, and the entrusted party is the drug production enterprise in Shanghai: within 20 working days for the first review. Qualified Application Subject: Scope of Application: Application for first review of drug production on commission by entrusting or entrusted drug production enterprises in Shanghai. Qualifications/Prerequisites for Application: 1 The entrusting party of the drug production on commission shall hold the registered number of approval for the very drug; and 2 The entrusted party of the drug production on commission shall hold the License of Drug Production and Certificate of Drug GMP complying with production of the very drug, and possess the conditions ensuring the production and quality of production of the very drug. |
Source: 上海市人民政府
Keywords:Quality Supervision
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