Application for First Review of Traditional Chinese Drug Variety Protection (inc

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

Processing Authority: Drug Registration Office under Shanghai Food and Drug Administration

Processing Procedures:

1. Acceptance: Drug Registration Acceptance Window of Shanghai Food and Drug Administration shall, upon receipt materials necessary for application, conduct the form review, and, within 5 days upon such receipt, make the decision of acceptance or not.

2. Technical Review: Shanghai Drug Review Center and Shanghai Institute of Drug Control shall be responsible for technical review and quality standard lab review (inspection) respectively. In case the lab review by Shanghai Institute of Drug Control is needed, the time frame for the technical review shall be no more than 80 days upon issue of the notice of acceptance and receipt of review charge, where the time frame for the lab review by Shanghai Institute of Drug Control shall be no more than 60 days upon receipt of full set of materials and samples. In case the lab review by Shanghai Institute of Drug Control is not needed, the time frame for the technical review shall be no more than 20 days upon issue of the notice of acceptance and receipt of review charge.

3. Integrated First Review: Drug Registration Office under Shanghai Food and Drug Administration shall, within 20 days upon completion of technical review, complete the integrated first review and bring out the opinion whereof.

Charging Standard & Basis: RMB 7,000 per variety as the first review charge for the traditional Chinese drug protection variety by Shanghai Food and Drug Administration.

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

Processing Basis: 1. Regulations on Protection of Traditional Chinese Drug Varieties under No. 106 Order of State Council;

2. Notice on Reinforcement of Protection and Administration of Traditional Chinese Drug Varieties under Wei Yao Fa [1995] No. 23 by Ministry of Public Health;

3. Notice on Administration of Extension of Protection Period of State-level Traditional Chinese Drug Protection Varieties under Guo Yao Guan Zhu [2000] No. 101 by State Food and Drug Administration;

4. Notice on Issue of Requirements and Notes for Items of Application Materials for Traditional Chinese Drug Protection Varieties under Zhong Bao Ban Fa [2003] No. 013 by State Commission of Review of Protection of Traditional Chinese Varieties; and

5. Notice on Review Charge for Protection of Traditional Chinese Drug Varieties under [1993] Jia Fei Zi No. 178 jointly issued by State Pricing Bureau and Ministry of Finance of the People's Republic of China

Any and all of above documents can be downloaded from http://www.zybh.gov.cn

Contact Tel: 63855666 ext.142

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

Time Limit for Processing:

1. For determination of acceptance by Drug Registration Acceptance Window of Shanghai Food and Drug Administration: within 5 days;

2. For review by Shanghai Drug Review Center: within 20 days;

3. For re-review by Quality Standard Lab of Shanghai Institute of Drug Control: within 60 days;

4. For integrated first review by Shanghai Food and Drug Administration: within 20 days; and

5. The time frame for processing the application for the same variety protection and extending protection period, technical review by Shanghai Drug Review Center, and integrated first review shall be reduced to half of the original time (subject to the deadline of acceptance by State Commission of Traditional Chinese Drug Protection).

Qualified Application Subject: any and all of traditional Chinese drug varieties that have obtained the registered number of approval in Shanghai, including Chinese patent medicines, extracts and preparations of natural drugs, and artificial products of traditional Chinese drugs, may apply for protection of traditional Chinese drugs. The approved traditional Chinese drugs may apply for extending the protection period. Drugs with the same variety specified in the State Announcement of Protection of Traditional Chinese Drugs may apply for protection of the same variety within the provided time frame.

Any and all of drug production enterprises holding the License of Drug Production and possessing the corresponding conditions and registered number of approval for drug production.

See the Notice on Issue of Requirements and Notes for Items of Application Materials for Traditional Chinese Drug Protection Varieties under Zhong Bao Ban Fa [2003] No. 013 by State Commission of Review of Protection of Traditional Chinese Varieties for the application form of the traditional Chinese drug protection variety, and requirements and notes for items of application materials for traditional Chinese drug protection varieties.

Source: 上海市人民政府

Keywords:Quality Supervision

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