Article 120th the State Food and Drug Administration issued adrug approval number, "the drug import registration certificate" or"pharmaceutical product registration certificate" valid for a period of 5 years. The expiry of the period of validity, need to continue production or import, the applicant shall, upon expiration of theapplication for registration again 6 months before the validity period.

Article 121st in the drug approval number, "the drug import registration certificate" or "pharmaceutical product registrationcertificate" within the validity period, the applicant shall, safety,efficacy and quality control of drugs, such as the monitoringsystem was evaluated during the period of the relevant research results, adverse reactions to the production control and product quality monitoring, uniformity etc..

Re registration application submitted by the drug approval numberholders to province, autonomous region, or municipality directly under the central government and drug supervision and administration department in accordance with the provisions ofarticle 122nd drugs, fill out the "application form for re registration of drugs", and provide the relevant application materials.

Re registration of imported drugs proposed by the applicant to the State Food and drug administration.

Article 123rd provinces, autonomous regions, municipalities directly under the central government, the pharmaceutical supervisory and administrative department to examine theapplication materials, to meet the requirements, issued anotification on acceptance of the application for re registration of drugs; do not meet the requirements, issued by the drug reregistration notice inadmissible, and the reasons.

Article 124th provinces, autonomous regions, municipalities directly under the central government, the pharmaceutical supervisory and administrative department shall, within 6 monthsto review the application for re registration of drugs from the date of receiving the application, in conformity with the provisions, to beregistered; not in conformity with the provisions, the State Food and drug administration.

Application for registration again 125th pharmaceutical import by the State Food and drug supervision and Management Bureau,and complete the examination within 6 months, in conformity with the provisions, to be registered; not in conformity with the provisions, issued a notice shall not be re registered, and explain the reasons.

Article 126th in any of the following circumstances shall not be re registered drug:

(a) before expiration of the validity term of fails to file the application for re registration;

(two) the request does not meet the State Food and Drug Administration approved the listing of the;

(three) did not complete the phase IV clinical trial in accordance with the requirements of the;

(four) without adverse drug reaction monitoring in accordance with the provisions of;

(five) by the State Food and Drug Administration and evaluationof curative effects are uncertain, serious adverse reaction, or other factors harmful to human health;

(six) in accordance with the "Drug Administration Law" shall cancel the drug approval certifications;

(seven) do not have the "Drug Administration Law" productionconditions;

(eight) fails to perform the responsibilities of monitoring period;

(nine) the other does not comply with the relevant provisions.

Article 127th the State Food and drug administration received theprovince, autonomous region, or municipality directly under the central government and drug supervision and managementdepartments of views, if it does not comply with the provisions on re registration of drugs, issued a notice shall not be re registered,and explain the reasons.

Re registration of non varieties, in addition to being revoked drug approval documents for legal reasons outside, after expiration of the term, the cancellation of its registered number of approval for drugs, "Drug Import Registration Certificate" or "pharmaceutical product registration certificate".