Technical Dossier Evaluation on Drugs
New Drug
New Drug Application (NDA)

According to the Article 7 and Paragraph 1, Article 39 of the Pharmaceutical Affairs Act, the term "new drugs" shall refer to drugs which are of the preparations having new chemical entities (NCE), new therapeutic compounds or new administration routes as verified and recognized by the central competent heath authority. Drugs shall be filed with the regulatory authority for registration and market approval. No manufacturing or importation of such drugs shall be allowed until a drug permit license is approved and issued. A new drug application shall follow the requirements set forth in the Regulations for Registration of Medicinal Products . Applicants should provide enough information to support the safety and the effectiveness. In addition, for helping those patients in life-threatening conditions, there are various expedited programs to speed up access to drugs. The following resources provide applicants to understand NDA classification, application fee, legal requirements, and review process.
Please find more information about NDA submissions at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

Ⅰ. CLASSIFICATION
  1. Classification Type
    New Drugs
    (According to the definition of “New Drug” in Article 7 of the Pharmaceutical Affairs Act)
    New Chemical Entities (NCE)、New Administration Routes、New Therapeutic Compounds*
    *Including new indications and new combinations
    Other New Drugs New Dosage Forms、New Dosing Regimens、New Strengths
    Biological Products Genetically Engineered Drugs、Biosimilar Products、Vaccines、Drugs Derived from Human Blood and Plasma、Allergenic Products、others
    Radiopharmaceuticals  
Ⅱ. APPLICATION FEES
  1. Please refer to Standards of Review Fees for the Registration of Western Medicines
Ⅲ. FORMS AND SUBMISSION REQUIREMENTS
  1. 1. An applicant shall submit an NDA application with the following documents:
  2. (1) The Form A and the Form B (Please refer to the announcement No. 1001405584 issued on September 19, 2011 and the announcement No. 1041405623 issued on November 12, 2015)
  3. (2) The NDA and BLA Refuse to File( RTF ) checklist (Please refer to the announcement No. 1081408565 issued on August 20, 2019)
  4. 2. An applicant shall submit documents in accordance with the Regulations for Registration of Medicinal Products and its appendices
    Category  
    New Drugs Please refer to Appendix 2 and Appendix 3
    Biological Products Please refer to Appendix 6 and Appendix 7
    Radiopharmaceuticals Please refer to Appendix 10 and Appendix 11
IV.NOTICE BEFORE SUBMISSION
  1. 1. An applicant may apply a Pre-NDA Meeting, Regulatory Consultation Services or a Module‐Based Rolling Review before submission to understand NDA registration requirements.
  2. 2. An applicant shall submit the application via one of the following ways:
  3. (1) PDF format in CTD specifications
  4. (2) The electronic dossier by the TFDA eCTD Builder
  5. 3. Contact Information:
    Type Recipient Address
    New application/ Re-evaluation the Food and Drug Administration (TFDA) (A) 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.)
    (B) Joint Services Center
    Address:No.161, Kunyang St., Nangang District, Taipei, 115-61, Taiwan (R.O.C.)
    Applicant's response / Extension request CDE
    (Original copy)
    The Center for Drug Evaluation (CDE)
    Address:3F No.465, Sec.6, Zhongxiao E. Rd.,
    Taipei 11557, Taiwan. R.O.C
    TFDA
    (Duplicate copy)
    (A) 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.)
    (B) Joint Services Center
    Address:No.161, Kunyang St., Nangang District,
    Taipei, 115-61, Taiwan (R.O.C.)
V. THE REVIEW TIME AND REVIEW PROCESS
  1. The NDA standard review time and process, please see tables below
  2.   Category Review time
    Standard Review NCE/ Biological Products 360 Days
    Non-NCE with clinical efficacy and safety data 300 Days
    Non-NCE without clinical efficacy and safety data 200 Days
  3. 1. An applicant may request a one-month extension if they are unable to respond to the deficiency letter within two months of the issuance date. The applicant should request in writing an extension before the requested response date. Please note the time extension can be requested only once.
  4. 2. An applicant may contact the project manager or submit requests for consultations via Consultation Services on Cases under Review if they have any question about the deficiency letter.
  5. 3. The review status may be inquired through the Status of the Application or the TFDA’s website https://www.fda.gov.tw/TC/cases.aspx
VI. EXPEDITED PROGRAMS
  1. The TFDA has developed five expedited programs to help to accelerate the application process. An applicant should apply for designation in advance. TFDA is responsible for evaluating applications for designation. There are specific criteria for each expedited program. If a drug meets these criteria, it is eligible for expedited programs. At the time of NDA submission, the applicant should provide the designation letter. The following tables provide a summary of these review programs:
  2. Abbreviated Review
    Qualifying criteria
    (All criteria shall be met)
    Category I Review Time 180 Days
    1. 1. New chemical entities (NCE)
    2. 2. Approved by two of the three regulatory agencies (US FDA, EMA, or MHLW/PMDA)
    3. 3. No ethnic difference in Bridging Study Evaluation (BSE)
    Category II Review Time 120 Days
    1. 1. New chemical entities (NCE)
    2. 2. Approved by the three regulatory agencies (USFDA, EMA, and MHLW/PMDA)
    3. 3. No ethnic difference in Bridging Study Evaluation (BSE)
    Requirements
    1. 1. The approval letter of USFDA, EMA and/or MHLW/PMDA, the assessment report, and the package insert.
    2. 2. The risk management plans and updated post-marketing commitment reports requested by US FDA, EMA and/or MHLW/PMDA
    3. 3. Unconditional approval of BSE waiver
    4. 4. Technical documents shall be provided in accordance with Appendix 3, or 7 of Article 39 of the Regulations for Registration of Medicinal Products.
    5. 5. All documents shall be submitted in CTD format and concordance with the submission to USFDA, EMA and/or MHLW/PMDA.
    Features
    1. 1. Category I: In principle, the review team will review CMC, clinical, and PK / PD sections. Other sections will be reviewed if necessary.
    2. 2. Category II: In principle, the review team will review CMC and clinical sections. Other sections will be reviewed if necessary.
    Reference
    1. The announcement No. 1081410630 issued on November 18, 2019, and its appendix-The Review Mechanism of Abbreviated Review.

  3. Priority Review
    Qualifying criteria
    (Two of the criteria shall be met)
    1. 1. New chemical entities (NCE);or new administration routes;or new therapeutic compounds
    2. 2. A drug is intended to treat a serious condition and address an unmet medical need with major clinical advance
    3. 3. A drug is intended to address a public health or an unmet medical need which is under priority counseling and grant for research from the government
    Review Time 240 Days
    Features The review process will be shorter than standard review; however, the evaluation will be under normal TFDA approval standards in safety, effectiveness, and quality.
    Reference The announcement No. 1081410630 issued on November 18, 2019, and its appendix-The Review Mechanism of Priority Review.

  4. Accelerated Approval
    Qualifying criteria
    (All of the criteria shall be met)
    1. 1. New chemical entities (NCE);or new administration routes;or new therapeutic compounds
    2. 2. A drug shall meet one of the following criteria:
    3. (1) A drug is intended to treat a serious condition and address unmet medical need;or
    4. (2) A drug is intended to address an unmet medical need and granted as orphan drug in any A10* countries;or
    5. (3) A drug is not an orphan drug in Taiwan; however, it is intended to address an unmet medical need and with difficulties of manufacturing or importing
    6. * A10 countries: US, UK, Japan, Switzerland, Canada, France, Australia, Germany, Belgium, and Sweden
    Review Time 240 Days
    Features
    1. 1. A drug in accelerated approval program may be approved on the basis of the effect on a surrogate endpoint to predict clinical benefit. It can shorten the time from R&D to marketing.
    2. 2. In principle, post-marketing confirmatory trials are required to verify its clinical benefit.
    3. 3. An applicant shall provide the plan of the post-marketing confirmatory trial(s) at the time of NDA application.
    Reference The announcement No. 1081410630 issued on November 18, 2019, and its appendix-The Review Mechanism of Accelerated Approval.

  5. Breakthrough Therapy
    Qualifying criteria
    (All of the criteria shall be met)
    1. 1. New chemical entities (NCE) ;or an approved drug is intended to treat serious conditions or rare diseases.
    2. 2. Preliminary clinical evidence indicates substantial improvement over available therapies on one or more clinically significant endpoints.
    3. 3. An applicant has conducted at least a clinical trial in Taiwan, especially clinical trials in the early phase.
    Review Time 240 Days
    Features
    1. 1. 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.
    2. 2. Module-Based Rolling Review:An applicant can apply for the Module-Based Rolling Review to CDE before submission. Please visit here for more information.
    3. 3. The proposed indication of the NDA should be identical to the indication of the breakthrough therapy designation.
    Reference The announcement No. 1081410630 issued on November 18, 2019, and its appendix-The Key Points of Breakthrough Therapy Designation.

  6. Pediatric and Rare Severe Disease Priority Review Voucher Program
    Qualifying criteria
    (All of the criteria shall be met)
    1. 1. New chemical entities (NCE);or new administration routes;or new therapeutic compounds
    2. 2. A drug is intended to treat a serious condition
    3. 3. The disease is mainly prevalent in pediatric population;or the prevalence of the disease is less than five per ten thousand.
    4. 4. A drug is intended to address an unmet medical need
    Review Time 240 Days
    Features
    1. 1. The proposed indication of the NDA should be identical to the indication of the pediatric and rare severe disease priority review designation:
    2. (1) The review process applies to Priority Review.
    3. (2) It is not necessary to submit BSE application in advance; however, the ethnic difference will be evaluated during the NDA review.
    4. (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.
    5. (4) For those drugs intended to treat pediatric or rare severe diseases, the approval standards may be flexible case-by-case. For example, reducing the number of clinical trials or subjects may be acceptable.
    6. (5) Data from stability studies on three batches should be provided generally. However, under special circumstances, an applicant may state the rationale and provide stability data from one batch.
    7. 2. TFDA will award priority review vouchers for those pediatric priority review voucher program applicants after the drug permit license is approved and issued.
    8. *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.
    Reference The announcement No. 1081410630 issued on November 18, 2019, and its appendix-The Key Points of Pediatric and Rare Severe Disease Priority Review Voucher Program