Risk Management Plan (RMP) / Risk Evaluation Mitigation Strategy (REMS)
Significance of RMP / REMS for Patient Safety
Generally, medicinal products are associated with adverse reactions, which vary in terms of severity, likelihood of occurrence, effect on individual patients and public health impact. At the time of initial marketing authorisation approval, all adverse reactions and risks would not have been identified, some risk shall only be discovered and characterised in the post-authorisation phase.
When RMP is Required?
Risk management plan (RMP) and is required to identify, characterise, and minimise a medicinal product’s important risks. RMP is legal requirement for initial marketing application and during post-authorisation phase of medicine.
When REMS is Required?
Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) may require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.
Our Solution for Complete Management of RMP / REMS Activity
AllyWorth supports marketing authorisation holders for the management of RMP and REMS including its product specific commitment across regions, which includes
- New RMP preparation (Bio-similar product, Hybrid product, Informed consent product, Generic product, Well established medicinal use product, Full MA application and Advanced Therapy Medicinal Products) and further updating it in-line with regulator's expectation.
- Tracking & Identifying updates impacting approved RMPs
- To update RMPs as per various regulatory sources (PRAC recommendation, competent authority request, etc.)
- Update RMP where there is change in benefit-risk balance of medicine.
- Development of Targeted Follow-up Questionnaires (TFUQs), Additional Risk Minimisation Materials (aRMMs) (e.g. Prescriber checklist, Patient alert card, HCP/Patient guide, Prescriber brochure, DHPC, HCP training materials, etc.) and Additional Pharmacovigilance (APhV) Activities (e.g. PASS study – pregnancy prevention plan for teratogenic drugs)
- Registration of PASS studies in EU PAS Register for the molecule like filgrastim.
- To support for the development of Pregnancy Prevention Programme for the teratogenic molecules if required.
- To support for the participation in the Pregnancy Registry for the teratogenic molecules if required.
- Tracking effectiveness of aRMMs and APhV activities using Process and Outcome Indicators
Significance of Compliance for RMP / REMS Activity and its Impact on Process
To achieve the compliance of above-listed commitment for each applicable approved RMP or REMS can be extremely challenging for any Global or Local Pharmaceutical Industry and Healthcare Organisation.
We have observed that, as an outcome of regulatory inspections, majority of the organisations receive either critical or major observation with respect to an achievement of RMP or REMS compliance specifically for the implementation of post-approval additional commitment. Therefore, to avoid such observation, it is crucial to collaborate with a seasoned and trustworthy service provider like AllyWorth to secure the optimal regulatory compliance.