By Srirekha Boddu
The Risk Management Plan (RMP) is a stand-alone, multi-part document that is updated by the marketing authorization holder throughout the product life cycle. The aim of a risk management system for medicinal products is to ensure a positive benefit/risk balance is achieved by the greatest margin possible for the individual patient and the target population.
Evolution of RMPs in the EU 
The concept of a risk management system was first introduced into EU legislation in 2005 through Regulation No 726/2004 and Article 8(3) of Directive 2001/83/EC. This EU pharmacovigilance legislation, which came into effect in 2012, required RMPs to be included in all new applications for a marketing authorisation. For medicines marketed prior to this date an RMP is not mandatory; however, safety concerns may trigger the need for an RMP.
Global Perspectives on Risk Management
United States: REMS
In the USA, the Food and Drug Administration Amendments Act (FDAAA), enacted in 2007, gave the FDA additional responsibilities to enhance drug safety. One of the provisions gave the authority to the FDA to require a Risk Evaluation and Mitigation Strategy (REMS). Provisions that became effective in 2008 authorise the FDA to require application holders to develop and comply with REMS if specific statutory criteria are met.
Japan and Other Regions
Similarly in Japan, an RMP was required for marketing approval application in 2013. With the growing use of formal RMPs in the ICH countries of US, Japan and Europe, other countries have started to request or require submission of either a local RMP or for copies of REMS or RMP that pharmaceutical manufacturers have submitted to other regulatory authorities.
Structure of RMPs across the globe
The structure of the RMP across different world ICH regions and for different institutions, does not follow a clearly defined format that is common for all world regions and countries.
The structure of the EU-RMP consists of 7 parts. The REMS contains specific sections to describe common REMS requirements and should include one or more goals, which describe the safety-related health outcomes that the REMS is designed to achieve, including the relevant measurable objective. An RMP in Japan should follow the structure and templates provided in the national guidelines, based on the ICH E2E Guideline. In Singapore, an RMP may follow either the EU-RMP or the REMS. Health Canada accepts the EU-RMP format or the REMS format as long as the essential elements are covered. Australia only accepts a risk management plan in the EU-RMP format. Many countries require a country-specific annex as an additional section in the RMP, irrespective of the format used.
Despite these structural differences in regulatory RMP requirements between jurisdictions worldwide, the common goal of all RMPs is to protect patient health by ensuring that the benefits of a medicinal product outweigh its risks.
Get in touch if you would like to find out how Pharmora can help you in developing RMPs, including how to comply with the requirements in different regions. Our expertise can guide you through the complex regulatory landscape, while ensuring alignment with your product profile and promoting patient safety.
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