The Risk Management Plan (RMP) has been considered a key document in numerous recent EU MAA assessments. It is mandatory and should be included in Module 1.8.2 of your product dossier for MAA application in EU as it is an essential source for safety data providing confidence and assurance for the innocuous use of the product. Nonetheless, RMP should be viewed also as a critical planning tool to minimize risks in the post-authorization phase and then make the most of the risk-benefit ratio.
So, when would be the most suitable moment to prepare the RMP during the development of the product? Here we provide some considerations depending on the status and extent of the medicinal product development.
First scenario would be creating the RMP early during product development. It is mostly applicable to a new chemical or new biological entity with full clinical package. It is generally attested that the safety information of the product will vary over time as the product entries the market making the RMP being continuously updated. However, despite differences in number and characteristics of patients between clinical trial phases and post-marketing, many safety concerns can be identified already at the clinical trial step. Thus, future pharmacovigilance activities can be well organized in advance and included in operational and financial plans. This safety specification and PV plan are compiled under Developmental Risk Management Plan which although it is not mandatory at the clinical development, it considerably allows an efficient transitions and ensures the RMP at the time of MAA.
Different situation would apply to generics or hybrid applications in which creating the RMP would be later in product development. The content and format of the RMP for these type of medicines are relatively straightforward as you can anticipate the risks by reviewing the clinical data and literature from reference products. Hence, RMP can be prepared in parallel to the MAA clinical modules set up, but always taking into account current scientific knowledge and possible updates due to the new formulation or target.
Here below you can see a more visual outline of the two approaches extracted from Regulatory Rapporteur – Vol 14, No 2, February 2017:
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