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| Application for First Review of Traditional Chinese Drug Variety Protection (including the first variety, the same variety, and the extended protective variety)
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| (06/21/2005) |
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.
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