Risk Management Plans
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Since November 2005 it has been obligatory to provide, as part of the Marketing Authorisation Application (MAA),
"A detailed description of the pharmacovigilance and, where appropriate, of the risk-management system which the applicant will introduce."
This may not be as onerous as it sounds. Depending on the nature of the medicinal product and the conclusions on the risks and benefits of the product drawn in the MAA, Akos can advise on the extent of the proposed risk management system and how far the EU template would need to be completed. The most important piece of advice is to start early! A good risk management plan is not one that can be pulled together while the MAA is being assembled: it should grow throughout the development programme so that it truly reflects the product and the clinical situation in which it will be prescribed.
As the Risk Management Plan is part of the Common Technical Document it is also required as part of a New Drug Application (NDA) in the US.
Akos can help with all aspects of the risk management proposals:
- Risk assessment
- Pharmacovigilance plan
- Risk Management Plans (RMP) - (EU)
- Risk Minimisation Action Plans (RiskMAP) - (US)
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk