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About Import Drug Registration Applications

Drug registration applications include applications for new drugs, generic drugs, imported drugs and their supplementary applications as well as re-registration applications. To apply for an import drug registration, the applicant shall fill out the Application Form for Drug Registration, submit relevant dossiers and samples, provide relevant approval documents, and submit the application to the State Food and Drug Administration.

Application for an imported drug refers to the registration application for drugs manufactured abroad to be marketed within the territory of the People's Republic of China. A drug being applied for importation shall have already obtained the drug marketing authorization in the producing country or region where the overseas pharmaceutical manufacturer is located; those that have not yet obtained marketing authorization in the producing country or region, may still be approved for importation by the State Food and Drug Administration if they can confirm safety and efficacy through clinical trials.

The generic drug shall have the identical active ingredients, route of administration, dosage form, strength, and therapeutic effects as a registered drug. When a drug has been produced by more than one manufacturer, the selection of registered drugs for comparative study shall be in accordance with relevant technical guidelines.

An overseas applicant applies for an imported drug registration, which shall be done by its branch in China or an entrusted agency within the territory of People's Republic of China. The people who handle the application for drug registration must have professional knowledge and be familiar with the laws and regulations on, and the technical requirements for, drug registration.

The applicant shall provide sufficient and reliable research data to prove the safety, efficacy, and quality of the drug, and be liable for the authenticity of all the dossiers submitted. The cited literature of the dossier of drug registration shall indicate the title of works or the name, volume number, issue, and page of the journal. Where the cited references are not published, an author's permission shall be provided. For foreign literatures, Chinese translation shall be provided as required.

The approval procedures can be divided into the approval of clinical trial and approval of imported drug application.

For Approval of clinical trials, four steps are involved

a. Application submission and review by SFDA (timeline: 30 days). It is important to submit the application in the format that SFDA requires. Once the application is received, SFDA will check the dossier content and format and send notification of quality test and specifications verification conducted by National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) (timeline: 85 days).

b. Technical Evaluation by the Center of Drug Evaluation (timeline: 90 days)

c. Final Decision by SFDA (timeline: 30 days)

d. If approved, Notification of Clinical trial protocol and the list of investigators to SFDA

For the approval of an imported drug application, three steps are involved:

a. Submission of clinical trial results and other amended or supplemental data by applicant

b. Technical evaluation by the Center of Drug Evaluation (timeline: 150 days)

c. Final Decision by SFDA (timeline: 30 days)

The timeline for drug registration in the Provisions refers to the maximum time for acceptance, review and approval of drug registration. The time for the suspension of the review and approval prescribed in laws and regulations or for the applicant to supplement data is not included.

The First difficulty in handling the application and approval of a foreign drug in China is the lack of familiarity with the laws and regulations in China. The success of handling an application of import drugs registration depends on the person or agent's familiarity of the laws and regulations on drug registration in China. The applicant should realize the difference between laws and regulations of drug registration in China and other countries in order to well prepare the applications according to the laws and regulations in China.

In terms of preparation of an application, the dossier for drug registration application shall be submitted at one time. No other technical materials should be added by the applicant after a drug registration application is accepted, with the exception of applications for special review and approval, new findings regarding drug safety, or supplementary materials that are requested. Also, It is required that all the materials including dossier and references in a language other than Chinese be translated in Chinese. The accurate translation is also a key factor in the approval of an application.

China SFDA encourages the research and development of new drugs and adopts the special review and approval with respect to innovative drugs, new drugs for serious and life-threatening diseases, and to address unmet medical needs and drugs. An application for new drugs refers to an application for registration of drugs that have not been marketed within the territory of People's Republic of China.

a. Active ingredients extracted from plants, animals, and minerals, etc. and their preparations not yet marketed in China

b. Chemical drug substances and their preparations and biological products not yet approved for marketing in China or abroad

c. New drugs for the treatment of diseases such as AIDS, malignant tumors, and rare diseases, etc. with significant clinical advantage

d. New drugs for the treatment of diseases, for which effective therapeutic methods are not available.

In addition, China SFDA encourages applications with new and advanced technologies and products with new technologies that have demonstrated efficacy, safety, and clinical needs.

a. Advanced technology and industrialization in pharmaceutical preparations

b. Advanced technology and industrialization in natural medicine and traditional Chinese medicine (TCM)

c. Advanced technology in bio/pharmaceutical research & development and industrialization

d. Advanced technology in small-molecule drug research & development and industrialization.

The most common issue in an application of an imported drug registration is preparation of the application. This heavily depends on the familiarity of laws and regulations on drug registration in China. Due to the differences of laws and regulations in different countries, the applicant must realize the requirements of application submission are different, and the applicant must meet all the requirements listed in the regulation. To overcome this issue, the applicant should

1. Get familiar with the laws and regulations for drug registration in China

2. Prepare the dossier and related materials according to the regulations

3. Keep good communications open with your agents in China as well the SFDA to get updates of changes in laws and regulations.