EMA releases draft guidelines on GVP for pregnancy prevention programs

Regulatory NewsRegulatory News | 15 March 2022 |  By 

The European Medicines Agency (EMA) has released a guideline on good pharmacovigilance practices (GVP) for pregnancy prevention programs in the European Union for public consultation.
A goal of a pregnancy prevention program (PPP), the agency said, is to have risk minimization measures (RMM) in place to reduce risk of exposure to medical products during pregnancy that are teratogenic or carry an adverse neurological effect on the child in utero but may also include limiting medications for men that could have a teratogenic effect during conception.
PPPs should be required based on current scientific evidence for level of teratogenicity and based on the context of the use of the medical product, according to the guideline. “The need for a PPP (or selected pregnancy-specific RMM instead) should be risk-proportionate in relation to the magnitude and nature of the teratogenicity (e.g. frequency, type or outcome of malformation) and may change when new evidence emerges,” EMA wrote.
A PPP should include RMM that states in the summary of product characteristics and package leaflet whether the product is contraindicated in pregnancy, contraindicated in women of childbearing age not using effective contraception, and details of the teratogenic risks of the product. The PPP should also have conditions for prescribing, which include the likelihood a patient will become pregnant, and patient counseling on pregnancy avoidance, pregnancy wishes, teratogenic risks of the medical product and the window of teratogenicity for the medication.
In cases where medical products meet some, but not all criteria for a PPP, “additional pregnancy-specific RMM are considered necessary,” the agency said. These include patient counseling by a medical professional, pregnancy testing before treatment and the patient starting effective contraception measures.
“If the use of the product by women of childbearing potential under the clinical conditions for which the product is authorised is considered unlikely (but the criterion of proven or strongly suspected teratogenicity in humans is fulfilled), routine RMM alone are usually considered appropriate,” EMA said. “If the likelihood of the use of the product in women of childbearing potential is difficult to predict, additional pregnancy-specific RMM may still be required, based on the assessment.”
For medical products where teratogenicity is unknown but possible, use RMM should consider whether the teratogenicity exists from testing on animals but there is inconclusive evidence of the effect in humans, what type of outcome occurred in animal testing, and if women of childbearing age would be using the product. “In principle, in most cases of possible but unconfirmed teratogenicity, it is expected that routine RMM will be sufficient. Additional pregnancy-specific RMM may still be required, based on the assessment,” EMA said.
The guidelines stated that RMM is not necessary for situations where teratogenicity is unlikely and the product is not being used by women of childbearing age. “However, routine RMM are still considered appropriate, in particular if the use of the medicinal product in women of childbearing potential may occur, even if very rarely, or is difficult to predict,” EMA noted.
Individual member states may want to consider a controlled access program for some medications based on the above criteria, and EMA acknowledged some of the requirements may need to be implemented differently depending on the healthcare system of a member state.
The draft for the guideline was finalized by EMA and Member States in November 2021 and released for public consultation in March 2022. EMA expects the finalized guideline will come into effect in the first quarter of 2023 after the public has an opportunity to comment.
Draft: Guideline on good pharmacovigilance practices (GVP)


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