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

Latest Issue

Latest Issue
PharmTech Europe

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

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.

Xie: What are the difficulties involved in handling the application and approval of a foreign drug in China?

SFDA: The First difficulty involves 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.

Xie: Can you tell me what is involved in the preparation of an application?

SFDA: 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.

Xie: What types of applications and indications for foreign drug approval are encouraged?

SFDA: The State 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.

Xie: Drugs with what technology platforms are simpler to receive approval in China?

SFDA: The 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.

Xie: Are there common issues that arise in the application and approval of a foreign drug, and how can one overcome them?

SFDA: 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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here