The European Medicines Agency is drafting guidelines for clinical research in pregnant and breastfeeding women. Researchers at Uppsala University have published a timely case report on how mother–infant lactation studies with biobanking can be designed to meet regulatory standards.
The EMA guidelines are based on a new guideline developed by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Evidence for the use of medicines in breastfeeding is urgently needed, for approved drugs and for the development of new drugs.
“There’s only evidence about medicine safety in breastfeeding for around 5% of drugs on the market. This is a problem for women. When their physicians don’t know if a medicine is safe, they advise to either not breastfeed or to stop using a medication. This is a health concern for both mother and infant, as breastfeeding offers benefits for both,” says Mats Hansson, senior professor of medical ethics at Uppsala University’s Centre for Research Ethics & Bioethics (CRB).
It is within the ConcePTION project, funded by the Innovative Medicines Initiative, that two mother-infant pair studies have been conducted, collecting breast milk and plasma from the mother and plasma from the infant. These studies target two patient groups – women with type-2 diabetes who take metformin and women with rheumatoid arthritis who take prednisolone – but demonstrating how to investigate potential drug transfer in association with breastfeeding can benefit many.
According to the authors, any evidence about what is safe must be based on standard operating procedures and relevant regulatory frameworks in order to be fit for label and clinical use. Their case report outlines the pressing need, standards and procedures for sampling (including informed consent), storage and handling, setting up a low-intervention clinical trial for already approved drugs and new.
“Based on our experiences from the IMI ConcePTION project, we have described the premises for mother–infant pair studies to be adhered to, hoping that this will lead to more clinical lactation studies being initiated,” Mats Hansson concludes.
By Anna Holm Bodin
Hansson M, Björkgren I, Svedenkrans J, Backman H, Hellman j, Englund-Ögge L, Magnusson M, Lindström I, Wutte A, Sundell E, Baranczewski P, Shaughnessy L. Setting up mother–infant pair lactation studies with biobanking for research according to regulatory requirements. British Journal of Clinical Pharmacology 2025;1-6. DOI: https://doi.org/10.1002/bcp.70201.
More information
Mats G. Hansson, senior professor of biomedical ethics, Uppsala University’s Centre for Research Ethics & Bioethics. E-mail: mats.hansson@uu.se, phone +46 76-341 20 50.
https://www.ema.europa.eu/en/ich-e21-guideline-inclusion-pregnant-breastfeeding-individuals-clinical-trials-scientific-guideline
Swedish demonstration studies
The ConcePTION breast milk collection for clinical lactation studies
BBMRI-ERIC sample data portal
Bioanalytical methods for breast milk and plasma
IMI ConcePTION project
Svedenkrans J, Hellgren K, Backlund K, et al. Determination of prednisolone concentration in human breast milk and plasma of breastfed infants: study protocol of a Swedish multicentre low-intervention clinical trial. BMJ Open. 2025;0:e097898. doi:10.1136/bmjopen-2024-097898
