By Nick Lung    Photo：CANVA

Taiwan has a strict management system for drug imports, with the aim of ensuring the safety and quality of people's drug use. Therefore, before importing drugs, companies need to fully understand the relevant regulations, especially the application and management regulations for "drug licenses". This article will explain the key points and practical precautions for applying for import licenses.

1. Drug imports must obtain approval from the Ministry of Health and Welfare

In Taiwan, drugs are highly managed special commodities. All drugs to be imported (including prescription drugs, finished drugs, biological preparations, etc.) must obtain a drug license issued by the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare. If imported drugs do not have a formal license, it is a violation and will face risks such as return, destruction or heavy penalties. Therefore, before any drug is imported, a legally established drug dealer, agent or medical institution in Taiwan must actively apply for relevant licenses.

2. Documents and procedures required for applying for a drug license

The application process for a drug license usually involves the preparation of multiple materials, including product ingredients and process descriptions, clinical or comparative data, GMP manufacturing certification and overseas marketing certification. The TFDA review time depends on the type of drug. For example, the review of new drugs may take 12 to 24 months, while the review of generic drugs is about 6 to 12 months. All information must be prepared in accordance with the ICH Common Technical Document (CTD) format to ensure scientificity and compliance. If the application process involves changes in the manufacturer, ingredient adjustments or packaging changes, it must also be re-approved or filed to avoid violations.

3. How to deal with special import situations

In addition to formal licenses, Taiwan also provides some special import mechanisms for specific situations. For example, if a medical institution has an urgent need, it can apply for "special project approval for import", but it is limited to in-hospital use and cannot be resold; drugs required for clinical trials must be reviewed by the IRB and approved by the TFDA for research purposes only. In addition, if a traveler brings a small amount of self-use drugs into the country, it must comply with the relevant quantity and use regulations, otherwise it will also be considered illegal.

4. Avoiding Violations and Practical Suggestions

Imported drugs must be handled with caution in regulatory procedures to avoid violating the law. For drug agents, they should first confirm whether they have legal drug dealer registration and obtain authorization and complete technical documents from foreign manufacturers before they can successfully apply for a license. At the same time, they should also plan application schedules and prepare materials in advance based on drug types and expected launch schedules. If it involves changes in formulations or factory transfers, professional pharmaceutical consultants or TFDA windows should be consulted to reduce administrative risks and commercial losses.

Drug imports are a professional and highly compliant operation, and the license application process is cumbersome but crucial. It is recommended that importers and drug-related companies should understand the system in advance, master the timetable, and work closely with regulatory consultants to ensure smooth acquisition of licenses, reduce risks, and improve efficiency.

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