Technical Dossier Evaluation on Drugs
New Drug
Risk Management Plan

A” Risk Management Plan (RMP)” is a document to assess the benefit-risk balance of a drug to prevent or minimize medication risks. TFDA introduced this regulatory regime by reference to the advanced countries, such as the US FDA and EMA. RMPs normally include medication guides, communication plans, risk mitigation measures, etc. It should be regularly modified and updated during the whole medicine lifecycle. The “Guideline on the Risk Management Plan and the Format” was issued on April 5, 2012, to assist pharmaceutical companies for preparation of RMP and ensuring further risk-minimization measures. According to Article 38-1 of the Regulations for Registration of Medicinal Products, an RMP is required for an application of NCE (New Chemical Entity) with non-CPP or domestic NCE. Other new drugs or marketed medicines may be requested to submit RMPs based on the drug safety assessment with the different levels of risk.

The following information introduces the submission of RMPs. Please find more information about NDA submissions at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

Ⅰ. CLASSIFICATIONS
  1. 1. Risk management plan and its post-approval changes
  2. 2. Risk management plan assessment report
Ⅱ. SUBMISSION REQUIREMENTS
  1. 1. Risk management plan:A cover letter to state rationale for application, and a risk management plan
  2. 2. Post-approval changes of RMP:A cover letter to state rationale for application, the latest approved RMP with the version number and date, an updated RMP, and a comparison table to indicate the difference between the current version and the proposed version of the RMP.
  3. 3. Risk management plan assessment report: A cover letter to state rationale for application, the latest approved RMP with the version number and date, and an RMP assessment report.
III. NOTICE BEFORE SUBMISSION
  1. 1. All non-CPP NCE or domestic NCE applications must have an accompanying RMP submission.
  2. 2. Post-approval revisions of the RMP should be submitted for assessment and approval by TFDA to maintain the safety of drugs.
  3. 3. An applicant should conduct the RMP following the latest version approved by the Ministry of Health and Welfare and in compliance with the “method” section, such as providing medication guides, regular educational training, special risk mitigation measures, etc. It recommends that the RMP assessment report should be updated regularly and the applicant should assess the effectiveness of those interventions routinely. In addition, an applicant should monitor and report adverse events and serious adverse events, and assess the relative information to evaluate whether to issue more safety warnings.
  4. 4. The RMP template, please refer to: RMP format and RMP report
  5. 5. RMPs should be written in Chinese.
  6. 6. 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.)
IV. REVIEW PROCESS

  1. 1. 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.
  2. 2. 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
V.FAQ