"We are ... the best of the best, IDL registration expert for your API business in China"  
- SwiCino® regulatory affairs team.

Imported Drugs License in China


The current CFDA regulatory environment is the most aggressive in the history. New regulatory policy changes since 2016.
 
  1. The official IDL regisitration fee was increased by 10 times more.
  2. ANY API and its Finished product must be binding together to apply for IDL and Market authorization, single API IDL application will not be accepted. (ONLY marriage will have a market entry ticket).
  3. All  generic drugs filling and registration in CFDA need Bioequivalence study data.  
  4. The manufacturers outside of China are subject to on-site inpection of CFDA.  
     
What is IDL?

Import Drug License. Imported Drugs License (IDL) is the drug marke entry permit which issued by Chinese FDA. All the pharmaceuticals (API, finished product and excipient) exported to China must obtain IDL before being commercialized in China according to the "Drug Administration Law of People’s Republic of China".

What SwiCino® can do for you?
 
  •           Function as both registration and distribution agent.
  •           IDL application for the very-difficult-to-register API.  
  •           Assess the feasibility of IDL registration in CFDA.
  •           Evaluate the risk of IDL registration in CFDA.
  •           Direct and smooth communication channel with CFDA.
  •           Review and provide guidance for improving the registration dossier.
  •           Compilation (including translation) and submission of registration dossier.
  •           Review specifications and labels.
  •           Track and monitor the whole process of IDL registration.
  •           Marketing and sales.

To enquiry the API IDL application in CFDA, please contact us.