China's State Food and Drug Administration Discusses Drug Applications - Pharmaceutical Technology

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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.

Pharmaceutical Technology
pp. 66-70

Xie: How does SFDA work with the Chinese Pharmacopoeia Commission?

SFDA: The Chinese Pharmacopoeia Commission is directly affiliated with SFDA and is responsible for

a. Compiling the Pharmacopoeia of The People's Republic of China

b. Establishing the state drug standard, packing material standard, equipment, and pharmaceutical excipients standard

c. Conducting state drug standard in testing phase in order to finalize the drug standard of China

d. Providing training and consulting for the state drug standard

e. Establishing standard information systems for state drug standard, participating in international exchanges and collaboration of drug standard

f. Publishing the journal of State Drug Standards and other drug-standard-related publications

g. Any additional tasks assigned by SFDA.

U.S. manufactures can find information about the Chinese Pharmacopoeia from the SFDA website or Chinese Pharmacopoeia Commission at http://www.chp.org.cn/ (only Chinese version is currently available).

Xie: How does SFDA work with the newly created International Pharmaceutical Excipients Council (IPEC) in China?

SFDA: IPEC-China was established in 2008 as a nonprofit organization. IPEC-China members are from pharmaceutical excipient manufacturers, users, and distributors. IPEC-China can assist with the SFDA and Chinese Pharmacopoeia Commission to improve safety of excipient application and guarantee public safety.

Xie: Where should manufacturers submit an application for review? To whom at SFDA and to what address should applications be submitted?

SFDA: Reception Center

State Food and Drug Administration

Address: A38, Beilishi Road, Beijing 100810, P.R. China

Office Hour: 8:30–11:30am / 13:00 –16:00

Tel: 010—68315572

Fax: 010—88330265

e-mail:

Xie: Can applications be submitted electronically, and if so, is there a templated form?

SFDA: Applicantants must use the software provided by SFDA to file an application. Both electronic files and hard copy must be submitted to The Reception Center at SFDA.

Xie: Do submissions need to be in Chinese?

SFDA: Yes, All submissions need to be in Chinese.

Xie: Is there a website where manufacturers outside of China can get contact information as well as more general information about SFDA and its drug approval/marketing process?

SFDA: Yes, the website of Reception Center (to download application, submit applications, and check the status of an application): http://www.sfda.gov.cn/WS01/CL0399/.

Xie: Is there any literature available that advises foreign manufacturers on the processes and procedures involved in submitting drug applications? Where/how can people obtain this literature?

SFDA: Literature is available at the website of the Reception Center: http://www.sfda.gov.cn/WS01/CL0147/. You can also check SFDA Order No. 28 (Provisions of Drug Registration) http://eng.sfda.gov.cn/cmsweb/webportal/W45649039/A64028429.html.

Xie: What is SFDA's working relationship with the US FDA, which now has offices in Beijing, Shanghai, and Guangzhou?

SFDA: SFDA is an important strategic partner of the USA. Both parties reached a consensus in 2007 on further expanding the exchange and cooperation between the food and drug regulatory departments of the two countries, hoping to conduct in-depth communication in the application of new technologies, guidelines of supervision, future strategic planning, and other aspects. Both parties are cooperating in the fields of pharmaceutical and biological products, and US FDA provides assistance in technical support and capacity building.

*This is the first in an ongoing series of interviews to be conducted by Advanced Pharmaceuticals, LLC, an international business engaged in technology transfer to China, licensing of drugs to China, and obtaining SFDA approvals for drugs and devices in China. This interview was translated by Ji Xie and Feng Li and edited by John R. Choate, all of Advanced Pharmaceuticals.


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