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ProjTitle.icon P.II.B.1. Risk management plan

Generally, risk management plans (RMPs) will reflect the measures considered necessary to identify, characterize, and minimize a medicinal product's important risks (GVP Module V). These aspects of the RMP should also reflect the available information for the product in relation to pregnancy and breastfeeding. Further, GVP Module V (V.B.5.5) states that “if the product is expected to be used in populations not studied and if there is a scientific rationale to suspect a different safety profile, but the available information is insufficient to determine whether or not the use in these circumstances could constitute a safety concern, then this should be included as missing information in the RMP." This statement is applicable to pregnant and breastfeeding women, as they are rarely included in clinical trials (see P.II.A.1.1.).

For products with anticipated use in women of childbearing potential there is a need to reflect the current understanding of safety in pregnancy and/or breastfeeding in the summary of the safety specifications in the RMP as follows: relevant knowledge gaps regarding risks associated with the use in pregnancy and/or breastfeeding should be included as missing information; data from non-clinical toxicity testing, observations in the pre-authorization phase or from products from the same pharmacological class, as well as signals arising in the post-authorization phase may result in describing important potential risks or important identified risks. For all three categories of safety concerns, recognition in the summary of safety specifications usually implies that additional pharmacovigilance activities for data collection and/or risk minimization measures may be needed (see GVP Modules V and XVI).

The RMP should specifically discuss the likelihood of use of the medicine in pregnancy, breastfeeding, and women of child-bearing potential in the light of the indications, alternative treatment options, the need for effective contraception and the complexities of changing treatment if use during pregnancy is to be avoided.

Rates of adverse pregnancy outcomes in women with specific underlying conditions may differ from baseline rates in the general population. Given that such specific underlying conditions may be the indication for prescribing, the background rates of adverse pregnancy outcomes in the target populations may need to be specified in the RMP, since such information has implications for the choice and interpretation of post-authorization surveillance methods. For example, women with diabetes have a higher risk of giving birth to a child with macrosomia and women with heart disease may have an increased risk of giving birth to a child with congenital heart defects due to genetic predisposition. This needs to be covered in the 'populations not studied' section of the RMP.

Potential risks should be assessed based on findings from standard non-clinical studies, clinical data and epidemiological data on the product or related products. This evaluation should inform what, if any, further studies and analyses are needed for the adverse events of special interest as well as for any associated risk minimization measures (RMM) to be implemented. The RMP also includes the RMM to be implemented and guidance for these is provided in P.II.B.7.​

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