Stakeholders

Accountability is a fundamental principle for successful regulatory procedures. Stakeholders need to be identified early in the process and consistently consulted in the development and/or revision of regulatory tools, methods and strategies. Stakeholders include pregnant and lactating women, women previously involved in research, parents, healthcare providers, patient advocates and community representatives. Engagement with those with lived experience ensures that regulatory tools and communication are fit for purpose and meet the needs of the stakeholders.

With regard to the safety surveillance of medicinal products for pregnant and lactating women and their infants, risk communication strategies need to be well established before an event occurs. Risk communication strategies should use language that is understandable, reassuring, and respectful of women’s emotions and concerns.

Lack of clear safety data may cause stress and uncertainty among pregnant and lactating women and their families. This may impact public mental health and have adverse socioeconomic impacts. Communicating transparently about what is known and unknown helps maintain trust.