Risk Management Plan (RMP) Requirements for NDA-1 Product Registration in Singapore

The Risk Management Plan (RMP) is a crucial component for the New Drug Application (NDA-1) product registration in Singapore, detailing essential risk management strategies for the product’s safety. The RMP must include several key documents, including:

Singapore-Specific Annex:

This annex outlines specific regulatory requirements and considerations for the product in Singapore.
Reference RMPs:

RMPs from EU or USA can be used as references, provided they are applicable to the product being registered in Singapore.
Key Elements of the RMP:
Pharmacovigilance Activities:

Routine pharmacovigilance and monitoring to ensure ongoing safety after market approval.
Risk Minimization Strategies:

The RMP should outline risk minimization activities, such as:
Educational Materials for healthcare providers and patients.
Controlled Access Programs for products with specific safety concerns.
Draft EU-RMP or US REMS:

If pending approval, a draft EU-RMP or US REMS (Risk Evaluation and Mitigation Strategies) can be submitted as part of the application.
Submission Requirements:
Softcopy of All RMP Documents:

All required RMP documents must be submitted electronically along with the NDA-1 application.
Additional Requests:

The Health Sciences Authority (HSA) may request additional pharmacovigilance or risk minimization measures after the submission for products marketed in Singapore.
The RMP is essential to ensure that the benefits of a product outweigh its risks and to outline how risks will be managed post-marketing.

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

Region:  Singapore