Risk Management Plans
<< back to Marketing Authorisation, New Drug Authorisation
What is Risk Management?
Risk Management is not a new concept. It simply puts a name to a strand that has always run through product research and development, namely the on-going balance of the possible benefit of a product against its potential risk. However, the implementation of requirements of the EU regulations in November 2005 means that, where appropriate, this strand has to be documented and presented for regulatory scrutiny in the form of a Risk Management Plan (RMP). Similar legislation in the US requires a Risk Minimisation Action Plan (RiskMAP) to be filed as part of the NDA.
What is the difference between Risk Management and Risk Minimisation?
Risk Management is the whole process of promoting safe use of a product. It includes Risk Assessment, pharmacovigilance and Risk Minimisation. Risk Minimisation is a series of measures by which identified and potential risks in clinical use can be reduced and preferably avoided.
What is a Risk Management Plan?
A Risk Management Plan is a document which presents the known safety profile of a product and the methods proposed for pharmacovigilance and risk minimisation. There is an EU template which has to be used if the RMP is to be submitted as part of a marketing authorisation application (MAA). The FDA does not have a template but will accept the EU template.
A Risk Management Plan contains four sections. The first is a safety specification which reviews the sponsor's nonclinical and clinical data, and puts it in the context of the prevalence of the condition, comorbidities and class effects. It also discusses any limitations or gaps in the clinical data, such as populations not adequately studied. Using this specification, known or potential risks are identified.
The second is a Pharmacovigilance Plan which discusses the methods by which the sponsor proposes to address the shortcomings identified in the Safety Specification. For the majority of products, routine pharmacovigilance will suffice, but for some, additional measures such as epidemiological studies might be appropriate.
The third section is an assessment of a need to undertake risk minimisation activities, and the fourth is a description of the proposed activities, including criteria to be used to assess their efficacy and the period over which these activities will be undertaken. Often, risk can be minimised by specific warnings in the SmPC/labelling, or restricting prescription quantities. Occasionally more rigorous methods such as patient registries may be required.
Do I need a Risk Management Plan?
There are several scenarios in which an RMP would be needed. When applying for a Marketing Authorisation for a new active substance, or a new formulation/route of administration of an established active substance an RMP is required in Module 1 of the CTD. Where a company identifies a new safety concern with one of its products an RMP may be the most effective way of presenting the situation and the proposed remedy to the regulatory authorities. Similarly, a competent authority may request an RMP if it feels the benefit:risk of a product in clinical use needs to be reviewed. Thus the continual assessment of the benefit:risk balance of a product is formalised between the company and the regulatory authorities.
Is this a Regulatory activity or a Pharmacovigilance one?
Ideally it should be a joint effort between all departments involved in product development, because it requires input on nonclinical and clinical data as well as PV plans.
Feeling lost?
Don't worry. Contact Akos. With expertise in the two key areas of Pharmacovigilance and Regulatory Development we are uniquely placed to write your Risk Management Plan, including - with your agreement - the Pharmacovigilance Plan and Risk Minimisation Plan.
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk