Importance of the Risk Management Plan (RMP) in NDA-1 Applications

The Risk Management Plan (RMP) is critical for NDA-1 product registration, detailing essential documents like the Singapore-Specific Annex and reference RMPs from the EU or USA. It focuses on routine pharmacovigilance and risk management activities, ensuring safety, including educational materials and controlled access programs for products with specific concerns. Draft EU-RMP or US REMS may be submitted if pending approval. All RMP documents must be included in softcopy with the application. The HSA may request additional pharmacovigilance or risk minimization measures after submission for products marketed in Singapore.

Source: https://www.hsa.gov.sg/rmp/product-registration-submission

Region: Singapore