China's State Food and Drug Administration Discusses Drug Applications

A Q&A with officers of the departments of State Food and Drug Administration, China, moderated by Ji Xie.
Nov 02, 2010
By PharmTech Editors

Xie: Can you provide me with a brief overview of SFDA application and approval of foreign drugs?

SFDA: 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.

Xie: What is the standard application procedure for an imported drug?

SFDA: 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.

Xie: What is the application for a generic drug?

SFDA: 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.

Xie: Who should file an application for an imported drug registration?

SFDA: 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.

Xie: What is required to provide in the application?

SFDA: 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.

Xie: What are the application and approval procedures for a foreign drug?

SFDA: 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)