The "Risk Management Plan(RMP)" is a set of activities to prevent or minimize medication risks, furthermore to ensure the benefits of a drug outweigh its risks. RMPs normally include medication guides, communication plans, elements to assure safety use, etc. It should be regularly modified and updated during the whole drug 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, applications for registration of new chemical entities (NCE) that do not include a Certificate of Pharmaceutical Product (non-CPP) or belong to domestically developed new chemical entities (NCE) must provide RMP. Other drugs or marketed medicines may be requested to submit RMPs based on the drug’s safety assessment with the different levels of risk. The following content will introduce the submission of RMP. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.

I.        Classifications:

(I)    RMP application and amendments

(II)   RMP assessment report

II.     Required Documents:

(I)   RMP application: an official letter to state the rationale for the application and a proposed RMP.

(II) RMP amendments: an official letter to state the rationale for the application, the latest approved RMP with the version number and date, an updated version, and a comparison table to indicate the difference between the the latest approved version and the proposed version (with explanation of the reasons for amendment).

(III) RMP assessment report: an official letter to state the rationale for the application, the latest approved RMP with the version number and date, and a RMP assessment report.

III.    Precautions:

(I)    Post-approval revisions of the RMP should be submitted for review and approved by the TFDA.

(II)   Please execute the RMP approved by the TFDA (version/date: ) faithfully, and submit assessment reports regularly according to the schedule outlined in the RMP. Please execute the "Implementation Methods" section faithfully , such as record of providing medication guides, conducting regular educational training, implementing element to assure safety use, etc., and assess their effectiveness. Please collect adverse events (AE) and serious adverse events (SAE) cases comprehensively, evaluate the relationship between AEs and the drug, and assess whether to issue more drug safety warnings.

(III) For the format and content description of the RMP, please refer to the Risk Management Plan (example) and Risk Management Plan Assessment Report Format (example).

(IV)  RMPs should be written in Chinese.

I.    Contact Information: 

II.    Risk Management Plan (RMP) Review Process:

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 period. 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.

III.    Consultation Services
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.

1.   Risk Management Plan (Example)
2.   Risk Management Plan Assessment Report Format (Example)