EU–RMP Vs

US REMS.

Dr Olusola B OlowookereMBCHB , MPH , MRSPH

SYNOPSIS

• What is a risk?• Risk Management & Risk Management Systems• EMA & FDA• EU RMP & US REMS• Considerations for US REMS• Components• Conclusion• References

WHAT IS A RISK ?

• Risk is a situation that could be dangerous or have an undesirable outcome.( Oxford dictionary)

• A probability or threat of a damage, injury, liability, loss, or other negative occurrence that is caused by external or internal vulnerabilities, and that may be neutralized through pre-emptive action.(Business dictionary)

RISK MANAGEMENT

• Companies must perform pre-market assessment and evaluation of potential risks associated with a product to determine the benefit/risk balance associated with a product and measures that will be put into place to minimize the risk of adverse medical consequences.

RISK MANAGEMENT SYSTEM

• A risk management system is a set of pharmacovigilance activities & interventions designed to identify, characterise, prevent or minimise risk relating to medicinal products, includes the assessment of the effectiveness of these interventions.

EMA & FDA

• EU & US have different approaches to drug safety due to difference in histories and philosophies.

• EMA : European Medicines Agency (1995)• FDA : Food and Drug Administration (1930)• The RMP and REM are risk strategy systems by

EMA and FDA respectively.

EMA & FDA

• FDA regulations regarding risk management has been growing since Thalidomide was found to cause birth defects.

• The passage of the Food & Drug administration amendment act of 2007 (FDAAA) mandated enforceable guidelines referred to as REMS.

• EU RMP implemented to law in 2005.

EU-RMP & US REMS

• EU-RMP :European union risk management plan are written documents that outline the product risks, the post marketing surveillance plan and risk minimization activities.

• US REMS : United states risk evaluation and mitigation strategies is a strategy to manage a known or potential serious risk associated with a drug or biological product.

EU-RMP & US REMS

• RMP and REMS are distinctly different but aim at achieving the same goal.

• The EU RMP is a compulsory requirement for all products to be submitted for registration in the European union.

• The US REMS is compulsory only for some medicines and can be limited to two years post product lunch.

CONSIDERATIONS FOR US REMS

• Size of population likely to use the drug• Seriousness of the disease or condition

indicated for the drug• Expected benefit of the drug with respect to

the disease condition its been used for.• Duration of treatment• Seriousness of any known or potential adverse

event.

• Whether the drug is a new molecular entity.

• REMS will be required if the FDA finds that REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risk of the product.

COMPONENTS

The US REMS consists of :• Medication Guide• Communication Plan• Elements to Assure Safe Use (ETASU)• Implementation System• Timetable for Submission of Assessments.

COMPONENTS

The main components of an EU RMP are :• Safety Specification .• Pharmacovigilance Plan.• Evaluation of the need of risk minimisation

activities.• Risk minimisation plan• Summary of EU RMP.• Contact person details.

• Template for EU RMP http://eudravigilance.ema.europa.eu/human/docs/19263206en.pdf

• Aspects absent from EU RMP but present in US REMS include specification of distribution or dispensing & monitoring of distribution.

• The REMS concerns itself with communication of risk, with the PI(Package Insert) been an integral part.

• The EU RMP is more complex, more far reaching safety package that sponsors are obliged to implement.

• The EU RMP aims at a proactive approach to the detection and assessment of risk and concurrent risk minimisation activities at an early stage.

• The EU RMP , with its built in precautionary measures and comprehensiveness would reduce or help avoid events like that of Vioxx and Avandia.

CONCLUSION

• Importance of risk management cannot be over emphasised

• US REMS and EU RMP both helps to minimise risk.

• The EU RMP is an engagement of wider scope and is binding on wider set of medicines than the US REMS.

References

• Giezen & Straus 2007, Risk management for biopharmaceuticals: the regulatory perspective.EJHP practice Vol 13

• Hoss A.D (2011), The Importance and impact of the EU RMP and US REMS to risk-benefit assessments. Regulatory Rapporteur-Vol 8,No 2.

• European Commission. Volume 9A of the rules governing medicinal products in the European Union – Guideline on pharmacovigilance for medicinal products for human us.

• http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000235.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac058001ce7d&jsenabled=true accessed 04.08.2011. 2.30am

• http://www.fda.gov/ accessed 04.08.2011. 3am

• http://www.pharmacovigilance.org.uk/risk-management/pharmacovigilance-risk-management-planning/

• http://www.registratmapi.com/Downloads/RM_RiskManagement.pdf

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