New Drug Application (NDA)
- Last updated：2024-08-16
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According to Paragraph 1 of Article 39 of the Pharmaceutical Affairs Act, the manufacturing and importation of drugs must be filed with the central competent health authority for registration and market approval. No manufacturing or importation of such drugs shall be allowed until a drug license is approved and issued. The fourth paragraph of the same article also stipulates that applications for drug registration should follow the “Regulations for Registration of Medicinal Products”. The regulation stipulates the matters to be noted and followed for various drug registration applications. Additionally, to effectively utilize review resources and improve drug accessibility for the public, the Taiwan Food and Drug Administration has announced several related review mechanisms so as to accelerate the market launch of new drugs and benefit patients.
The subsequent content will provide an overview of the process for applying to a new drug registration. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.
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Review Time |
1. NCE/ Biological Products: 360 days 2. Non-NCE with clinical efficacy and safety data/Biosimilars: 300 days 3. Non-NCE without clinical efficacy and safety data: 200 days |
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As one of the two categories is chosen: Criteria (all items (1) to (3) must be met) |
1. Category I Abbreviated Review: (1) Defined as new chemical entities (NCEs). (2) Approved by two of the following regulatory agencies: FDA (US), EMA (EU), or MHLW/PMDA (Japan). (3) No ethnic difference in Bridging Study Evaluation (BSE). |
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2. Category II Abbreviated Review: (1) Defined as new chemical entities (NCEs). (2) Approved by FDA (US), EMA (EU), and MHLW/PMDA (Japan), with identical chemical manufacturing and control (CMC) data. (3) No ethnic difference in Bridging Study Evaluation (BSE). |
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Required Documents |
1. The Abbreviated Review desiganation letter, relevant registration documents, and fees at the time of registration. 2. Provide approval, assessment reports, and package inserts from FDA (US), EMA (EU), or MHLW/PMDA (Japan). 3. Submit the latest progress reports on the risk management plan (RMP) and post-marketing commitment as required by FDA (US), EMA (EU), or MHLW/PMDA (Japan). 4. Provide documents proving exemption from bridging studies, which should not be conditional exemptions. 5. Submitted documents should comply with the Common Technical Document (CTD) format and be identical to those submitted to FDA (US), EMA (EU), or MHLW/PMDA (Japan). |
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Features |
1. Category I Abbreviated Review (1) Review time is 180 days. (2) Primarily focuses on chemistry, manufacturing, and controls (CMC), clinical data, and pharmacokinetics/pharmacodynamics (PK/PD). Other sections are reviewed as necessary. |
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2. Category II Abbreviated Review (1) Review time is 120 days. (2) Primarily focuses on chemistry, manufacturing, and control (CMC) and clinical data. Other sections are reviewed as necessary. |
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Criteria (2 out of 3 items must be met): |
1. Defined as a new drug under Article 7 of the Pharmaceutical Affairs Act. 2. Meets both of the following conditions: (1) To treat severe disease. (2) To address an unmet medical need, offering a major advance in treatment. 3. To address a public health or an unmet medical need which is under priority counseling and grant for research from the government. |
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Required Documents |
The Priority Review designation letter, relevant registration documents, and fees at the time of registration. |
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Features |
1. Review time is 240 days. 2. The review standards do not change due to priority review. The new drug must meet safety, efficacy, and quality requirements to be approved for marketing. |
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Criteria (both item 1 and 2 must be met) |
1. Defined as a new drug under Article 7 of the Pharmaceutical Affairs Act. 2. The claimed indication meets one of the following conditions: (1) It is considered a severe disease and satisfies unmet medical needs. (2) It meets unmet medical needs and has obtained orphan drug designation in any one of the A10 countries*. *The A10 countries are Germany, the United States, the United Kingdom, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden. (3) It is not an orphan drug; however, it is intended to address an unmet medical need and with difficulties in manufacturing or importing. |
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Required Documents |
The Accelerated Approval desiganation letter, relevant registration documents, and fees at the time of registration. |
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Features |
1. Review time is 240 days. 2. Based on scientific evidence, surrogate endpoints may be used in clinical trials as indirect or surrogate assessment methods to represent clinically meaningful improvements, thereby shortening the drug development timeline for marketing. 3. In principle, post-marketing confirmatory trials are required to verify its clinical benefit . 4. At the time of new drug application (NDA), Applicant shall provide the plan of the post-marketing confirmatory trial(s), including but not limited to the expected trial completion and report submission date. |
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Criteria (all items 1 to 3 must be met) |
1. New chemical entity (NCE) or an approved drug is intended to treat serious conditions or rare diseases. 2. Preliminary clinical evidence demonstrates substantial improvement in clinical efficacy endpoints over current therapies. 3. Conduct clinically meaningful trials in Taiwan, especially clinical trials in the early phase. |
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Required Documents |
The Breakthrough Therapy designation letter, relevant registration documents, and fees at the time of registration. |
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Features |
1. Review time is 240 days. 2. Interactive communications：An applicant should report the implementation progress and the R&D plan to TFDA at least every 3 months after designation. If an applicant has any regulatory issue, they can request the consultation with TFDA. 3. Module-Based Rolling Review：An applicant can apply for the Module-Based Rolling Review to CDE before submission.. 4. The proposed indication of the NDA should be identical to the indication of the breakthrough therapy designation. |
For more details, refer to the announcement No. 1081410630 dated November 18, 2019.
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Criteria (all items 1 to 4 must be met) |
1. Defined as a new drug under Article 7 of the Pharmaceutical Affairs Act.. 2. To treat severe disease. 3. The disease primarily affects the pediatric population or has a prevalence rate of less than 0.05%. 4. Intended to address an unmet medical need. |
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Required Documents |
The Pediatric or Rare Severe Disease Priority Review Voucher Program designation letter, relevant registration documents, and fees at the time of registration. |
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Features |
1. Review time is 240 days. 2. The proposed indication of the NDA should be identical to the indication of this mechanism. (1) The review process applies to Priority Review. (2) It is not necessary to submit BSE application in advance; however, the ethnic difference will be evaluated during the NDA review. (3) It is not necessary to provide the certificate of a pharmaceutical product (CPP) at the time of NDA submission. However, a valid free sale certificate* (FSC) should be provided before approval. The FSC and CPP can be waived only if the applicant has conducted clinical trials in Taiwan. (4) Considering drugs intended for treating pediatric or rare severe diseases, the standards for the number of clinical trials and the number of subjects may be appropriately adjusted during review case-by-case. (5) Data from stability studies on three batches should be provided generally. However, an applicant may state the rationale and provide stability data from one batch under special circumstances. 3. TFDA will award priority review vouchers for those pediatric priority review voucher program applicants after the drug permit license is approved and issued. *This certificate is issued by the highest health competent authority of the issuance country to indicate the drug is legally marketable in the issuance country. |
(II) The NDA Refuse to File (RTF) Checklist (Refer to the announcement No. 1131406955 dated June 18, 2024). For the data sheet and declaration form mentioned in the RTF checklist, please refer to the following announcement：
1. " Clinical Trial Data Sheet For GCP Inspection” (Refer to the announcement No. 1121414566 dated January 5, 2024)
2." Data Exclusivity and Domestic and Foreign Clinical Trial Data Sheet" (Refer to the announcement No. 1131406955 dated June 18, 2024)
3." Declaration form of the status of pharmaceutical patents " (Refer to the announcement No. 1091400039 dated January 15, 2020)
(III) Please refer to Regulations for Registration of Medicinal Products and appendices for required documents for drug applications:
I. Applicant can choose one of the following ways to submit an application for registration:
1. Physical document submission: Prepare 2 copies of electronic data discs which comply with the the "CTD format" announced by TFDA, and submit primarily in PDF format.
2. Online submission: Submit online through the Online Application Platform (ExPress) or via eCTD.
Note: For eCTD submissions, please comply with the relevant regulations of Announcement No. 1101411462.
II. Contact Information:
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Type |
Recipient |
Address |
Online Submission |
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New application/ |
TFDA |
National Biotechnology Research Park Building F (Address: Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan (R.O.C.)) |
Online Application Platform (ExPRESS) (Please visit the TFDA website > Business Section > Drugs > Drug Review and Registration Online Application) |
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Applicant’s response/Extension request |
CDE (Original) |
Center for Drug Evaluation (CDE) |
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TFDA (Copy) |
National Biotechnology Research Park Building F (Address: Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan (R.O.C.)) |
III. Flowchart for NDA Application and Review:
Note:
(I) If the applicant is not able to meet the deadline, a written statement should be submitted to support the application of an extension. The extended deadline is one month after the expiry date of the original correction time. Only one extension will be allowed.
(II) If there are special issues requiring expert opinions after the technical dossier review, external experts or the Drug Advisory Committee will be consulted as needed.
(III) If there are any questions regarding the content of the official letter, applicants can contact the project manager (PM) or apply for Review Related Consultation (RRC).
(IV) For case review status, please visit the TFDA website > Drugs > Case review status.
(V) To comply with the electronic drug regulation management, applicants should file or update the package insert information on the online platform upon receiving the draft approval of the package insert.
The CDE has extensive knowledge of domestic and international regulations and years of review experience. We provide diverse regulatory consultation services for industry and research departments at various stages, from drug development to market entry. We welcome all applicants to utilize these services to prepare regulatory-compliant submission documents. For application details, please see Consultation Services.
For the review fees, please refer to Standards of Review Fees for the Registration of Western Medicines.
I. The TFDA website > Business Section > Drugs > Registration Section > Application Guidelines and Checklists
II. The TFDA website > Business Section > Drugs > New Drug Section > New Drug Registration Application Section > Related Forms Download