1.

WHAT IS IDL
Imported Drugs License (IDL) is the drug marketing permit which issued by State
Food and Drug Administration (SFDA) or SDA) of China. All the pharmaceuticals
(API,F/F and excipient ) exported to China must obtain IDL before being marketed in
China according to the Drug Administration Law of Peoples Republic of China.
2 .Is it necessary to apply for Imported Drug License of API,F/F and excipient in
China?
According to the Drug Administration Law of Peoples Republic of China,all
pharmaceuticals (API,F/F and excipient) which exported to China must be registered
in China before being marketed in China. The pharmaceuticals (API,F/F and excipient)
are allowed to distribute in China after being obtained Imported Drug License (IDL)
only.


When the documents are ready, we will start the translation and submit the
application to SFDA.
1. After SFDA verified the dossiers completeness, SFDA will issue a registration
number and a notice if acceptance.
2. Once SFDA received the registration application fee from applicant, the samples
will be inspected and tested by National Institute of Control Pharmaceutical and
Biological products(NICPBP), and the dossier will be received by the centre if Drug
Evaluation(CDE).
3. If the testing approved, NICPBP will issue a testing fees payment notice and a draft
of Imported Drugs specification to CDE for further evaluation after received
applicants confirmation letter and the testing fee.
4. The CDE will form a group of 4 specialists (rapporteur and 3 corapporteurs) to
examine the dossier and final evaluation.
5. If CDE comment the dossier is not complete, CDE will issue the notice to applicant
for request supplementary, modification or explanation. Generally, CDE only give one
chance for applicant to submit the supplement, and the applicant should submit the
supplement to submit the supplement, and the applicant should submit the supplement
within 120 days as requested by CDE.
6. The applicant must submit the supplement to us 30days before the deadline. We
will translate, compile, and check the completeness of the supplement immediately. If
the dossier is not ready, we will give the specialized comment for further action.
7. If the application or supplements are disapproved, CDE will report to SFDA and
comment the application is not accepted. SFDA will make the final decision
according to the CDE comment. Then, the disapproval notice will issue and send to
the application.
8. If the application or supplements are accepted. CDE will issue and request the
applicant confirm the final draft of specification, label and manual on the product. The
applicant should submit the official confirmation within 20 days ( Note: For future
commercial import , the quality, the quality must comply with that specification.)
9. Once received the confirmation, CDE will report to SFDA and comment the

application is accepted, and publish the application acceptance on the web.
10. The application will pass to SFDA. Which will print out the draft of IDL,
specification and label/ SFDA will send the original IDL and documents to applicants
agent.


How long does it take to get an IDL in China ?
Usually, it takes about 1.5-2 years for APIs and excipients, and about 2-3 years for F/F.
The application time mainly depends on the documentation provided and sample
testing and whether the clinical trial on F/F is needed or not. The estimated schedule
as show below:
1. SFDA accepts the registration dossier and we obtain the application registration
number(2-3months)
2. CDE evaluation and get the acceptance for sample testing by NICPBP(1-2months)
3. Sample testing (2-4months)
4. CDE evaluationchecking results and all dossier(4-6months)
5. Generally, receive notification from CDE for supplement. Applicant should
submit the supplement within 3 months.(3 months)
6. re-evaluation and specification confirmation(3-4months)
7. IDL printing (1-2months)


How much does it cost for an IDL registration?
A. The official fees include 3 parts:
1. Registration fee (around USD 7,190)
2. Inspection testing fee (around USD 3,900-USD 7,100), depends on the testing
items).
3. If needed, Clinical trial or test fee. (Applicant needs to provide all related
samples and reference standards for quality testing or clinical trial, as well as
the related equipments if needed)
B. Unofficial fee which includes translation, market survey and relationship
maintenance.