Chinese Pharmaceutical Guidebook Series

Sample page

Chapter 3. Genera-Regulations on Application and Approval for Imported Drug Registration

3.1.Classification of Drugs

In China, pharmaceutical products are divided into four categories that are chemical drugs, biological products, traditional Chinese medicines (TCM) and natura-drugs. For administering requirement of drug registration, every category is further divided into several sub-categories. Such classification of drugs is named as classification of drug registration.
“Chemica-drugs” refer to the chemical raw material medicines manufactured by synthetic techniques and their formulations, as well as the effective chemical entities (CEs) extracted from natural substances and their formulations.
“Biologica-products” refer to the pharmaceutical products containing active ingredient extracted from organism, the pharmaceutical products manufactured by recombinant DNA techniques, as well as the pharmaceutical products for gene and body cell therapy.
“Traditiona-Chinese medicines” refer to the drug substances and their formulations used under the Chinese traditional medicine theory.
“Natura-drugs” refer to the drug substances and their formulations used under modern medicine theory.

3.2.Definitions

It is necessary to understand the definitions of some basic terms used in application and approval process of drug registration before introduction of application and approval for imported drug registration.

-The term “ applicant for drug registration “(hereinafter referred to as applicant) refers to an entity that files the application for drug registration, bears the corresponding legal liabilities, and holds the certifications of approval for drugs after the application is approved. A domestic applicant shall be an entity with legal person status that lawfully registered within China, and an overseas applicant shall be a lawful overseas drug manufacturer.

-The term “drug registration” refers to the examination and approval process by conducting systematic evaluation of the safety, efficacy and controllability of quality of the drugs to be marketed, and by making the decision on whether or not to approve the drug clinical investigation, drug manufacturing or import. The process includes the examination and approval of the contents indicated in the certifications of approval for application for drug alteration and in the attachments.

-The term “application for drug registration” includes the application for new drugs, application for drugs with the existing national standards, application for imported drugs, and the supplementary application.

-The term “application for imported drugs” refers to the application for registration of the drugs that are manufactured overseas and marketed in China.

-The term “application for new drugs” refers to the application for registration of drugs that haven't been marketed within China. If the dosage form or the route of administration of any drugs that have been marketed within China is changed, and the new indication of any drugs that have been marketed within China is added, the said drugs should be administered as new drugs.

-The term “application for drugs with the existing national standards” refers to the application for registration of the drugs for which the SFDA has promulgated official standards.

-The term “supplementary application” refers to the application for alteration, adding or cancellation of the approved matters or contents after the applications for new drugs, drugs with existing national standards or imported drugs have been approved. If an application for registration of the drugs during the examination and approval or an approved application for clinical investigation needs to be altered correspondingly, or if transferring the new drug technologies, repackaging the imported drugs, and formalizing the tentative drug standards, the procedures for supplementary application should be followed.

- The term ”drug registration inspection” includes sample inspection and drug standard review conducted on the drugs applying for registration.

- The term “sample inspection” refers to the inspection conducted by the institute for drug control on the samples pursuant to the drug standard supplied by the applicant.

- The term “drug standard review” refers to the lab inspection and examination conducted by the institute for drug control with respect to the feasibility, rationality of the inspection methods specified in the drug standard supplied and whether the quality indications set by the standard can control the drug quality etc.

- The term “re-registration of drugs” refers to the examination and approval conducted on the drugs continuing to be manufactured and imported after the valid term of the drug approval certifications expires.

- The term “nonprescription drugs “ refers to the drugs promulgated by the SFDA that the customers may judge, purchase and use by themselves without the prescriptions given by practicing physicians and practicing assistant physicians.

- The term “repackaging of imported drugs” refers to changing big drug packages into small ones after the final formulations are finished overseas, or making external packaging, placing specifications and affixing labels etc for drugs of which the internal packaging has been finished overseas .

- The term “time limits in drug registration” refers to the maximum time periods allowed for finishing the examination and approval, inspection and supplementing of materials relating to drug registration.

- The “Criterions for the Quality Control of Drug Manufacturing” is also called the “Good Manufacturing Practice , GMP” in China. It is equivalent to the GMP in other Western countries.

- The “Criterions for the Quality Control of Clinical Trial of Drugs” is also called the “Good Clinical Practice, GCP” in China. It is equivalent to the GCP in other Western countries.

- The “Criterions for the Quality Control of Non-clinical Trial of Drugs” is also called the “Good Laboratory Practice, GLP” in China. It is equivalent to the GLP in other Western countries.