Taiwan Controlled Drug Import 2026
Narcotics, psychotropic substances and related raw materials are strictly controlled under Taiwan law.
Controlled drugs in Taiwan are graded Schedule I to IV. Schedule III-IV drugs may be imported by a pharmaceutical business holding a controlled drug registration: besides the drug permit under the Pharmaceutical Affairs Act, it must obtain a TFDA import consent for each shipment before customs clearance. Schedule I-II drugs are imported only by the TFDA pharmaceutical factory (Article 4 of the Controlled Drugs Act); ordinary pharmaceutical businesses cannot import them. Ordinary individuals cannot apply for commercial import.
Contents
1. What are controlled drugs and when is import consent needed?
Taiwan controlled drugs are divided into Schedules I-IV, including narcotics, psychotropic substances and related raw materials. Importers must confirm the schedule, use and required TFDA documents before shipment.
2. Differences between Schedules I-IV
| Schedule | Examples | Control level | Import rule |
|---|---|---|---|
| Schedule I | Morphine, cocaine, heroin | Extreme control | Imported only by the TFDA pharmaceutical factory (Art. 4); ordinary pharmaceutical businesses cannot import |
| Schedule II | Codeine, oxycodone, cannabinoids | High control | Imported only by the TFDA pharmaceutical factory (Art. 4); ordinary pharmaceutical businesses cannot import |
| Schedule III | Some codeine compounds, phenobarbital | Medium control | Import consent for each shipment after registration |
| Schedule IV | Benzodiazepines, Z-drugs | General control | Import consent for each shipment after registration |
Actual classification follows the latest TFDA announcements; dosage form and concentration may affect the schedule.
3. Eligibility: individuals cannot apply for commercial import
Controlled drug import businesses generally need:
- A legally established pharmaceutical business
- Controlled drug registration for import activity
- A qualified controlled drug manager
Even licensed pharmaceutical businesses must complete controlled drug registration before importing controlled drugs.
4. Prerequisite: controlled drug registration
Controlled drug registration is the prerequisite for import consent applications.
| Applicant | Pharmaceutical business intending to import controlled drugs |
|---|---|
| Manager qualification | Pharmaceutical dealers and manufacturers: an in-house pharmacist (a dealer whose controlled drugs exclude narcotics may appoint an assistant pharmacist); medical institutions: a physician, dentist or pharmacist (an assistant pharmacist may serve if the controlled drugs it purchases exclude narcotics) |
| Fee | About TWD 1,000; exact amount follows official announcements |
| Application channel | TFDA controlled drug section or TFDA online application platform |
5. Four steps for import consent
Systems: CDMIS or TFDA online application platform
Confirm registration
Confirm the company holds valid controlled drug registration and has a qualified manager.
Log in and fill the application
Enter drug name, dosage form, strength, quantity, purpose and supplier details.
Upload documents and pay fee
Upload required documents and pay the fee, about TWD 1,000 per case.
Clear customs after approval
Review usually takes about seven business days when documents are complete.
6. Patients carrying controlled drugs into Taiwan
Patients with valid prescriptions carrying Schedule I-III controlled drugs into Taiwan may apply for a patient carry-in declaration.
| Item | Description |
|---|---|
| Who can apply | Patients carrying Schedule I-III controlled drugs with valid prescriptions |
| Documents | Doctor certificate, passport copy and related documents |
| Fee | Free |
| Review time | About seven business days |
| Channel | TFDA controlled drug section |
| Arrival note | Declare to customs and keep prescriptions for inspection |
7. Fees and processing time
| Controlled drug registration fee | About TWD 1,000; follow official announcements |
|---|---|
| Import consent fee | About TWD 1,000 per case; follow official announcements |
| Import consent review | About seven business days when documents are complete |
| Patient carry-in declaration | Free, about seven business days |
| Schedule I-II drugs | Imported only by the TFDA pharmaceutical factory (Art. 4); ordinary pharmaceutical businesses cannot import |
8. FAQ
Companies without controlled drug registration cannot import controlled drugs. Registration and a qualified manager are required first.
Apply to TFDA, appoint a qualified controlled drug manager, and submit the required documents before applying for import consent.
Schedule III-IV drugs can be imported by businesses holding a controlled drug registration, but each shipment needs its own import consent. Schedule I-II drugs are imported only by the TFDA pharmaceutical factory under Article 4; ordinary pharmaceutical businesses cannot import them.
Patients with valid prescriptions may apply for a declaration where required and must declare to customs on arrival.
Import consent is about TWD 1,000 per case and review is about seven business days, subject to official announcements.
CDMIS is the controlled drug management system. The TFDA online platform is a general application portal. Confirm the current workflow before filing.
Not sure whether your medicine is controlled?
Use the HowBridge Logistics member tool to match CCC codes and import rules before preparing customs documents.
Check import rules View permit guide