How to Apply for Imported Drug License (IDL) for China
John Li 2017-11-16 2017-11-28
IDL stands for imported drug license (进口药品注册证）in China. According to Chinese Law on Drug Administration, anyone who wishes to import pharmaceutical products (including APIs and excipients) to China must register their products with CFDA and obtain imported drug license (IDL) first. In this article, we will give you an overview of how to register imported pharmaceutical products in China and apply for the IDL. Please note that IDL is required for customs clearance.
Imported Drug License (IDL) Sample
The sample of IDL can be found below:
How to Apply for Imported Drug License (IDL) for China
To ge the IDL, you must register your products (including finished pharmaceutical products and APIs) with CFDA by following the following steps:
Step 1: Know Your Product Category
There are 5 categories for chemical drug registration, 15 categories for biological products and 15 categories for traditional medicine. Registration procedure, data requirement and timelines will depend on your product category.
Take chemical drug registration for example, there are 5 categories.
- Category I: New drugs not yet marketed in any country
- Category II: Modified new drugs that have not been marketed in any country
- Category III: Drugs that are imitated by domestic applicants to original drugs that have been marked abroad but not domestically
- Category IV: Drugs that are initated by domestic applicants to original drugs that have been marked domestically
- Category V: Drugs that have been marked aboard and apply to be registered in China.
Category V is the most common registration type for imported pharmaceutical products in China. We will use this as an example to show you the registration procedure and data requirement for registering imported chemical drugs in China.
Step 2: Follow the Procedure
For imported drugs, foreign manufactures must firstly appoint a local registration representative to handle drug registrations and liaison with CFDA. Applicants must conduct clinical trials locally in China. Prior to conducting clinical trials, the applicants must firstly apply for Clinical Trial Approval (CTA). Once the CTA has been issued, applicants shall notify their clinical trial protocols to CFDA and then start the trial. Once clinical trial data is available, applicants shall submit it along with other data (i.e, chemistry manufacturing & control, toxicology) in a registration dossier to CFDA (e-CTD formatin future).
- Overseas clinical trial data may also be accepted for new drug registration provided that the data meets certain technical requirements.
- For imported APIs, local clinical trial data is not required if national drug standards are already available.
- For imported generic formulations that have already been marketed in China, CFDA will evaluate wether bioequivalence study or clincial trial can be waived.
The table below summarizes the complete procedure and estimated timelines for the registration of imported drugs in China.
Step 3: Know Your Dossier Data Requirements
|Type of Approval||Dossier Data Requirements|
|Clinical Trial Approval (CTA)||
(I) Summary data
a) Name of drug; b) Approval documents; c) Objective and rationale for the study; d) Summary and evaluation of study results; e) A draft of insert sheet, notes to the draft and the latest literatures; f) Draft of the designed package and label.
(II) Pharmaceutical research data (CMC)
g) Overview of pharmaceutical research data. h) API production process research data and literature; drug formulations and processes research data and literature. i) Testing data and literature for confirmation of chemical structure or components. j) Testing data and literature data for quality research. k) Drug standards and the drafting instructions, and standard substance or reference substance. l) Sample inspection report. m) Sources of pharmaceutical APIs and excipients, quality standards, and inspection reports. n) Testing data and literature for drug stability studies. o) Rationale for selection and specifications of immediate packaging material and container.
(III) Pharmacology and toxicology research data
p) Review of pharmacology and toxicology research data. q) Main pharmacodynamic testing data and literature. r) General pharmacology testing data and literature. s) Acute toxicity testing data and literature. t) Long-term toxicity testing data and literature. u) Allergic (topical, systemic and light sensitive toxicity), hemolytic and local (blood vessels, skin, mucous membranes, muscle, etc.) irritation and other special safety related testing data and literature. v) Testing data and literature for interactions of the efficacy, toxicity and pharmacokinetics of multiple ingredients in compound preparation. w) Carcinogenicity testing data and literature. x) Reproductive toxicity testing data and literature. y) Carcinogenicity testing data and literature. z) Dependence testing data and literature. aa) Non-clinical pharmacokinetic studies and literature.
(IV) Clinical trials data
bb) Summary of related clinical trial data at home and abroad. cc) Clinical trial protocols and study protocol. dd) Clinical investigator's brochures. ee) A draft of Informed Consent, Ethics Committee’s approval letters. ff) Clinical trial reports. Specific requirements for the above application dossiers are detailed in Annex II of the “Provisions for Drug Registration”.
|Imported Drug License (IDL)||Everything above plus trial results. It takes longer time for CFDA-CDE to view full registration applications.|
The picture below explains CFDA's internal procedure.
Supplementary Registration for Imported Drugs
In case of the following changes, registrants shall submit supplementary registrations to CFDA:
- Changes of packaging materials or containers in direct contact with drugs (except for supplementary application item 10 approved by CFDA).
- Changes in the production place of APIs for imported drugs and preparations.
- Change the appearance of imported drugs, but do not change the drug standards
- Modify the package inserts of imported drugs in accordance with the requirements of national drug standards or CFDA provisions.
- Supplement and improve the safety section in imported drugs’ package inserts.
- Change the package labels of imported drugs as required.
- Changes in drug registration application agencies for imported drugs.
- Other changes.
- CFDA regulatory guide: Approval for clinical trials of imported (incl. from Hong Kong, Macao and Taiwan) chemicals
- CFDA regulatory guide: Verification and issuance of registration certificates for imported chemicals (incl. from Hong Kong, Macao and Taiwan)