Human drug registration and approval services
| 1、 Registration and approval of domestic drugs | |
| 1.1 Application for clinical trial of domestic drugs
a. Clinical trial of domestic production of traditional Chinese medicine b. Clinical trial of domestic chemical drug registration c. Clinical trial of domestic production of biological products for treatment d. Clinical trial of domestic biological products for prevention |
1.2 Application for registration and marketing license of domestic produced drugs
a. Registration and marketing license for domestic production of traditional Chinese medicine b. Registration and marketing license for domestic production of chemical drugs c. Registration and marketing license for domestic production of therapeutic biological products d. Registration and marketing license for domestic production of biological products for prevention e. Registration and marketing license for in vitro diagnostic reagents produced in China under the management of biological products |
| 1.3 Supplementary application for domestic produced drugs
a. Supplementary application for domestic produced drugs |
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| 2、 Registration and approval of imported drugs (including imported drugs and temporarily imported drugs) | |
| 2.1 Clinical trial for registration of drugs produced abroad
a. Clinical trial of overseas production of traditional Chinese medicine b. Clinical trial of overseas chemical drug registration c. Clinical trial of overseas production of biological products for treatment d. Clinical trial of overseas production of biological products for prevention |
2.2 Application for re registration of overseas produced drugs
a. Application for re registration of overseas produced drugs b. Supplementary application for overseas produced drugs |
| 2.3 Supplementary application for overseas produced drugs
a. Supplementary application for overseas produced drugs
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2.4 Registration and marketing license for overseas produced drugs
a. Registration and marketing license for overseas production of traditional Chinese medicine b. Registration and marketing license of overseas produced chemicals c. Registration and marketing license for overseas production of biological products for treatment d. Registration and marketing license for overseas production of biological products for prevention e. Registration and marketing license of in vitro diagnostic reagents managed as biological products for overseas production |
| 2.5 One time import (National Bureau)
a. One time import (National Bureau) |
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| 3、 Registration and approval of Hong Kong, Macao and Taiwan pharmaceutical products (including imported drugs and temporarily imported drugs) | |
| 3.1 Clinical trial of medical product registration in Hong Kong, Macao and Taiwan
a. Clinical trial of Chinese medicine registration of Hong Kong, Macao and Taiwan pharmaceutical products b. Clinical trial of chemical drug registration of Hong Kong, Macao and Taiwan pharmaceutical products c. Clinical trial on the registration of medical products and biological products for treatment in Hong Kong, Macao and Taiwan d. Clinical trial on the registration of biological products for prevention of pharmaceutical products in Hong Kong, Macao and Taiwan |
3.2 Application for re registration of Hong Kong, Macao and Taiwan pharmaceutical products
a. Application for re registration of Hong Kong, Macao and Taiwan pharmaceutical products |
| 3.3 Supplementary application for Hong Kong, Macao and Taiwan pharmaceutical products
a. Supplementary application for Hong Kong, Macao and Taiwan pharmaceutical products |
3.4 Hong Kong, Macao and Taiwan Medical Product Registration and Marketing License
a. Registration and marketing license of Hong Kong, Macao and Taiwan pharmaceutical products b. Registration and marketing license of pharmaceutical products and chemicals from Hong Kong, Macao and Taiwan c. Registration and marketing license for medical products and biological products for treatment in Hong Kong, Macao and Taiwan d. Registration and Marketing License for Biological Products for Preventive Use of Hong Kong, Macao and Taiwan Pharmaceutical Products e. Medical products from Hong Kong, Macao and Taiwan are registered and marketed according to in vitro diagnostic reagents managed by biological products |
| 3.5 One off import of pharmaceutical products from Hong Kong, Macao and Taiwan (National Bureau)
a. One off import of pharmaceutical products from Hong Kong, Macao and Taiwan (National Bureau) |
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| 4、 Issuance of certificate of protected varieties of traditional Chinese medicine | 5、 Issuance of import and export license for narcotic drugs and psychotropic substances |
| a. Issuance of Certificate of Protected Varieties of Traditional Chinese Medicine (initial)
b. Issuance of certificate of protected varieties of traditional Chinese medicine (the same variety) c. Issuance of certificate of protected varieties of traditional Chinese medicine (extended protection period) d. Approval of change of certificate of protected varieties of traditional Chinese medicine |
a. Export approval of narcotic drugs and psychotropic drugs
b. Examination and approval of the import of narcotic drugs and psychotropic drugs for clinical use c. Examination and approval of the import of narcotic drugs and psychotropic drugs for teaching and scientific research |
| 6、 Registration of APIs, excipients and packaging materials | 7、 Other |
| a. Drug substance registration
b. Registration of pharmaceutical excipients c. Registration of drug packaging materials |
a. Drug registration inspection
b. Drug clinical trial registration c. Bioequivalence and clinical trial filing of chemical generic drugs d. Filing of overseas produced drugs e. Filing of medical products in Hong Kong, Macao and Taiwan |
| Agency service：If you need agency service or entrusted testing, please write E-mail (caowei@jizhun.com.cn) or call (+86-20-81695425) to contact Mr. Cao Wei. | |