The pharmaceutical market is growing with the rise in pharmaceutical innovations in Taiwan. The Taiwan Food and Drug Administration (TFDA) is the central Taiwan drug regulatory authority responsible for the pharmaceuticals products registration and drug regulations in Taiwan. All pharmaceuticals must comply with the regulations and Taiwan drug registration guidelines set forth by the Taiwan drug regulatory authority, TFDA, to ensure safety, efficacy, and quality for the Taiwanese market.
Reading further this blog will help you comprehend the key requirements of Taiwan FDA regulations.
Taiwan FDA Drug Registration Types:
The drug product registration in Taiwan depends upon the type of category of drug product, which is enlisted below:
| Category Of Drug Product | Key Points |
| New Drug (NDA) | Drugs with new chemical entities. Requires detailed documentation of clinical and non-clinical data. Requires longer time for approval. |
| Generic Drug (ANDA) | For approved drugs listed in the reference listed drugs (RLD). Requires CMC and bioequivalence documentation. Shorter approval time. |
| Imported Drug |
Depends upon, of the imported drug is approved in Taiwan or not.
Type I: Imported and not approved in Taiwan Type II: Imported and already approved in Taiwan |
| Orphan Drug |
Orphan drugs are applicable for incentives and expediated review process.
|
| Biosimilar | Requires clinical and bioequivalent studies data. Stringent regulatory procedures. |
Classification of Pharmaceutical Products In Taiwan
One of the initial steps in the Taiwan FDA Product registration process is the classification of the pharmaceutical product. The Taiwan drug regulatory authority, TFDA, classifies drugs into various categories based on factors such as the level of risk and it’s intended use. These classifications determine the specific requirements and documentation necessary for the Taiwan FDA Product registration process.
Depending on whether your product is a new drug or a generic version of an existing one, you will follow one of two application paths. New Drug Applications (NDAs) involve more comprehensive data requirements, including preclinical and clinical studies. Generic Drug Applications require comparative bioavailability studies to demonstrate that the generic drug is equivalent to the reference product.
New Drugs and New Drug Application (NDA) in Taiwan
Taiwan drug registration guidelines define “new drugs” as those with new chemical entities (NCE), new therapeutic compounds, or new administration routes recognized by the central competent health authority. They must undergo registration and market approval. These new drug classifications encompass various categories, including NCE, new administration routes, new therapeutic compounds, and more.
Applicants must submit an NDA application with specific documents including Form A and Form B, the NDA and BLA Refuse to File (RTF) checklist, and documents in compliance with the Regulations for Registration of Medicinal Products and its relevant appendices. Prior to NDA submission, applicants have the option to apply for a Pre-NDA Meeting, Regulatory Consultation Services, or a Module-Based Rolling Review to gain a better understanding of NDA registration requirements. Submissions can be made in PDF format in CTD specifications or through the electronic dossier using the TFDA eCTD Builder.
The review process for NDA Taiwan follows different timelines based on the type of drug. New chemical entities (NCE) and biological products typically undergo a standard review of 360 days, while non-NCE drugs with clinical efficacy and safety data face a 300-day review. Non-NCE drugs without clinical efficacy and safety data have a 200-day review period. Extensions and inquiries can be made in certain circumstances to ensure a smooth process.
Abbreviated New Drug Applications (ANDA) in Taiwan
The classification of generic drugs in Taiwan is based on the presence or absence of the active ingredient in the medicine on the list of post-marketing surveillance. The two categories are as follows:
- Generic drugs with active ingredients on the list of post-marketing surveillance.
- Generic drugs with active ingredients not on the list of post-marketing surveillance.
Understanding the classification as per Taiwan drug registration guidelines is essential to determine the appropriate registration process and associated requirements.
The application fees for ANDA Taiwan are determined by the latest Standards of Review Fees for the Registration of Western Medicines and Medical Devices, issued by the Ministry of Health and Welfare. The fees depend on whether the active ingredient in the generic drug is on the list of post-marketing surveillance:
- Active ingredient on the list of post-marketing surveillance: TWD 80,000.
- Active ingredient not on the list of post-marketing surveillance: TWD 50,000.
These fees are a crucial consideration for pharmaceutical manufacturers seeking to register generic drugs in Taiwan.
Applicants have the option to submit requests for pre-ANDA meetings to discuss the format and content of the submitted documents. This proactive step allows for clarity and alignment with the regulatory expectations, ensuring a smoother application process. For further details, applicants can refer to the Chinese version web page or contact relevant entities like the subsidiary of the company, the local agent, or a Contract Research Organization (CRO).
Supplements or amendments for deficiencies should be submitted within two months after receiving the deficiency notice. In cases where two months are insufficient, applicants can request an extension of up to one month from the final date of resubmission with an application form, limited to one application.
Applicants can submit requests for consultation via the provided platform if they have concerns regarding deficiencies. The status of the review can be tracked and monitored through the official websites of the Center for Drug Evaluation Taiwan (CDE) and the Taiwan Food and Drug Administration (TFDA).
TFDA Drug Approval Process:
The following is the TFDA approval process:
- Pre-Submission:
- Registration type determination.
- Local agent appointment.
- Dossier preparation.
- Submission:
- E-submission through the TFDA portal.
- Payment of the fees.
- Review by the TFDA:
- Review by all team members according to the product category.
- Consultation meeting scheduled.
- Packaging and Labeling review:
- Review of packaging insert, label, outer box.
- Approval and Grant of License:
- The license granted upon approval is valid for a period of 5 years.
- Post-marketing requirements:
- Conduction of Post marketing surveillance.
- Reporting of adverse events.
- Submission of annual reports.
TFDA Regulations For Import Of Pharmaceuticals:
The key regulatory requirements for Import of Pharmaceuticals in Taiwan are as follows:
- The pharmaceuticals imported in Taiwan should have the Drug Permit License (DPL) issued by the TFDA.
- The DPL requires renewal every 5 years.
- Every shipment sent to Taiwan should possess an Import Permit issued by the TFDA.
TFDA Pharmaceuticals Labeling Requirements:
The general requirements for labeling in Taiwan are as follows:
- The labeling instructions must be written in Chinese.
- All the information written should not be misleading and have proper scientific evidence.
- The label should contain the following aspects:
- Drug name
- Strength
- Dosage form
- Storage conditions
- Batch no
- Manufacturing and Expiry date
- Registration number
- Warnings/Special indications
Taiwan Local Agent Requirements For Drug Registration
Drug manufacturers without a local office in Taiwan must appoint an in-country regulatory representative or Taiwan Agent. The agent plays a crucial role in facilitating communication with the TFDA and ensuring compliance with local regulations.
Quality System Requirements
In the realm of pharmaceuticals, the establishment of good manufacturing practices, encompassing manufacturing, processing, re-packaging, packaging, storage, and distribution of Western medicinal products, will draw its guidance and reference from the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Submission of Application To TFDA
After compiling all required documentation, including preclinical, clinical, and quality data, you can submit your application to the TFDA. This submission will undergo a rigorous review process, during which the Center for Drug Evaluation Taiwan may request additional information or clarification.
TFDA Review and Approval In Taiwan
The Center for Drug Evaluation Taiwan will meticulously assess your application, reviewing the safety, efficacy, and quality of the drug. Once the review is complete, and the TFDA is satisfied with the provided data, they will issue the drug registration approval. This approval grants the right to market and sell the drug in Taiwan.
Post-Market Surveillance
The responsibility doesn’t end with registration approval. Pharmaceutical companies must continue to meet post-market surveillance and reporting requirements to ensure the ongoing safety and efficacy of their products in the Taiwanese market.
TFDA Guideline Updates For 2025:
Some of the new guideline updates in Taiwan for pharmaceuticals are as follows:
- In January 2025, the GMP certificate issuance was made mandatory.
- In March 2025 the TFDA implemented policies to enhance the access for orphan drugs.
- In March, the regulations for registration of new chemical substances were also updated.
Advantages Of TFDA:
Below are some of the key advantages of TFDA:
- Strong regulatory global framework.
- Efficient digital platform.
- Incentives provided by the Taiwan government for innovations.
- Review process with expediated pathway for certain drug categories.
- Supportive system for local and international pharma manufacturers.
- Efficient digital platform.
Conclusion:
The TFDA is a globally recognized health authority regulating pharmaceuticals to ensure the safety, efficacy and quality of pharmaceuticals in Taiwan. Thus, it is essential for the foreign as well as domestic manufactures to comply with the TFDA requirements to entry the pharma market in Taiwan. The transparent system and international collaboration serve as an advantage for manufacturers in Taiwan.
Navigating through the stringent guidelines of TFDA can be challenging sometimes. Our well-experienced team at Artixio, with local expertise in Taiwan assist you throughout your regulatory journey in Taiwan.
Contact Artixio now to get started on your journey to pharmaceutical market success in Taiwan. Your success is just a message or call away!
FAQs:
Does TFDA accept foreign GMP certificates?
Yes, TFDA accepts foreign GMP certificates, however they may still carry out site inspections.
How are controlled substances regulated in Taiwan?
In Taiwan, pharmaceutical controlled substances are managed through regulations with stringent compliance requirements. They also require a special license for its sale.
How can the manufacturers know if the drug is registered with TFDA or not?
The manufacturers can check the approval status of drug on the TFDA portal in the drug license search portal.
Does TFDA recognize US FDA or EMA approvals?
US FDA or EMA approvals can expedite the approval process; however, the drug needs to be registered with the TFDA separately.
