Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling
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KeywordsPregnancy, breastfeeding, lactation, fertility, reproductive toxicity,
teratogenicity, contraindication, clinical assessment, non-clinical
assessment, risk assessment, labelling, Summary of Product Characteristics
(SmPC). - Introduction
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The PRAC and CHMP work plans for 2023 [1,2] list several activities intended to implement guidance
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on ?Special populations and products?.
- This includes further optimising close cooperation between
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these two Committees for the revision of the ?CHMP Guideline on risk assessment of medicinal products
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on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005)? [3].
- Further, there is guidance on how to communicate the potential or identified risk through
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the Summary of Product Characteristics (SmPC).
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Most data regarding human pregnancy exposures are collected after marketing authorisation by
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spontaneously reported post-authorisation data, in patient/pregnancy registries, and via
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epidemiological studies undertaken in such data sources [7].
- Such data sources are available in the
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EU, as compiled by the European Network of Centres for Excellence in Pharmacovigilance and
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51Pharmacoepidemiology (ENCePP) 1.
- The development of
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2http://www.encepp.eu/structure/documents/Data_sources_for_medicines_in_p...
https://database.ich.org/sites/default/files/ICH_E21_Final_Concept_Paper...Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
on Human Reproduction and Lactation: from Data to Labelling
EMA/CHMP/170670/2024Page 2/6
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physiologically based pharmacokinetic (PBPK)-modelling approaches may facilitate the prediction of
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drug exposure in breast milk based on scarce data.
- Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum III ? Pregnancy
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prevention programme and other pregnancy-specific risk minimisation measures
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(EMA/608947/2021) 4,
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3.
- Recommendation
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The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk
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Assessment Committee (PRAC) recommends the revision of the current ?Guideline on risk assessment
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of medicinal products on human reproduction and lactation: from data to labelling? considering the
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issues identified above.
- Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
on Human Reproduction and Lactation: from Data to Labelling
EMA/CHMP/170670/2024Page 5/6
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[2] EMA/CHMP.
- Guideline on risk assessment of medicinal products on human reproduction and
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lactation: from data to labelling (EMEA/CHMP/203927/2005).
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Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
on Human Reproduction and Lactation: from Data to Labelling
EMA/CHMP/170670/2024Page 6/6