170th Chinese medicine and natural medicine, chemical medicine,biological products, supplementary application, re registrationapplication materials and requirements please refer to Annex 1,annex 2, Annex 3, Annex 4, Annex 5, Annex 6 Provisionsmonitoring period.
Article 171st drug approval number format: the country medicine accurate H (Z, S, J) + 4, + 4 bit sequence number, which represents H chemicals, Z represents the traditional Chinese medicine, S represents biological products, J represents therepackaging of imported drugs.
"Card" card number of Drug Import Registration Form: H (Z, S) 4first 4 bit sequence number; "pharmaceutical product registrationcertificate" certificate number format: H (Z, S) C4 first 4 bitsequence number, which represents H chemicals, Z represents the traditional Chinese medicine, S biological products. For local package with large packaging specifications of the registration certificate, the certificate number and the letter B in the original registration certificate no..
New drug certificate number format: Chinese medicine card characters of H (Z, S) + 4, + 4 bit sequence number, which represents H chemicals, Z represents the traditional Chinese medicine, S on behalf of biological products.
172nd the provisions of the province, autonomous region, or municipality directly under the central government and drug supervision and administration department for approval,acceptance, add re registration approval, is the State Food and Drug Administration commissioned matters. The State Food and drug administration can also be commissioned by the province,autonomous region, or municipality directly under the central government and drug supervision and administration departmentfor drug registration matters other technical review or approval.
Article 173rd the State Food and Drug Administrationimplemented code management approved drug. The provisions of the drug code management shall be formulated separately.
Article 174th of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive pharmaceuticals registration, except in accordance with the provisions of these measures, shall also comply with other relevant provisions of the state.
175th approval number of Chinese herbal medicine, Chinese herbal medicine and Chinese herbal medicine of the provisions on the administration of registration of import, shall be separately formulated by the State Food and drug administration.
Article 176th drug technology transfer and commissioned the production of measures shall be separately formulated.
Article 177th the measures shall be implemented as of October 1, 2007. Drug registration management measures the State Food and Drug Administration in February 28, 2005 published "" (the State Food and drug administration order No. seventeenth) shall be repealed simultaneously.
Annex 1: Traditional Chinese medicine, natural medicineregistration classification and reporting data requirements
Annex 2: classification and application materials of chemicals registration requirements
Annex 3: biological product registration and declarationinformation requirements classification
Annex 4: supplementary drug application registration and declaration of data requirements
Annex 5: drug re registration information items