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.
What are the difficulties involved in handling the application and approval of a foreign drug in China?
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.
Can you tell me what is involved in the 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.
What types of applications and indications for foreign drug approval are encouraged?
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
d. New drugs for the treatment of diseases, for which effective therapeutic methods are not available.
Drugs with what technology platforms are simpler to receive approval in China?
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.
Are there common issues that arise in the application and approval of a foreign drug, and how can one overcome them?
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.