Question 9 of 20 Fundamentals Concept
How does an EU risk management plan differ from a US REMS?
Short answer
Every new EU marketing authorisation application includes a risk management plan (RMP) describing the safety specification, the pharmacovigilance plan and risk minimisation. A US Risk Evaluation and Mitigation Strategy (REMS) is required only for certain medicines with serious safety concerns, where labeling alone is not enough.
Why
GVP Module V describes the EU RMP in parts. The safety specification lists important identified risks, important potential risks and missing information. The pharmacovigilance plan says how each will be studied, including any post-authorisation safety studies.
The risk minimisation plan says how risks will be reduced, through routine measures such as the product information and, where needed, additional measures such as educational materials or controlled access. The RMP is updated through the product's life. The US approach is different in scope.
FDA describes a REMS as a drug safety program it can require for certain medicines with serious safety concerns, to make sure benefits outweigh risks. Most US products have no REMS and manage risk through labeling and routine pharmacovigilance. A REMS may include a medication guide, communication plans or elements to assure safe use, such as prescriber certification or monitoring before dispensing.
So a product can have an extensive EU RMP and no REMS at all, while the reverse is impossible, because every EU product has an RMP.
A strong answer covers
- RMP for every new EU application, REMS only when required
- Safety specification, pharmacovigilance plan, risk minimisation
- Routine versus additional risk minimisation
- REMS elements such as medication guide and elements to assure safe use
- Both are living documents
Common mistakes
- Treating RMP and REMS as the same document under different names.
- Assuming every US drug has a REMS.
- Forgetting that the RMP must be updated after approval.
The interviewer might ask next
How would you measure whether an additional risk minimisation measure is working?