Report explaining the regulatory procedures, their scientific requirements, priorities and decision-making pathways regarding the use of medicines in pregnancy and lactation

Task 6.2: Promote a common understanding of regulatory authorities and their use of evidence (M1 – M18) (i~HD, KUL, EMA, MHRA, NVS, Lilly, Takeda, UCB, JAN, Teva). This task will help all consortium partners and external stakeholders to share a common understanding of the scope, roles and responsibilities of different regulatory agencies at European and national levels, how they work, their statutory powers and in particular their decision-making pathways when assessing new evidence on the use of medicines in pregnancy and lactation. A review and synthesis of regulatory publications and relevant EFPIA partner internal guidelines, supplemented by stakeholder consultations (e.g. interviews, surveys, current FDA and EMA work on patient-focused drug development) will be undertaken with the goal to ensure consortium partners, advisory board members and external stakeholders have a common understanding of the current regulatory frameworks that govern evidence assessment to understand impact of medicines used by pregnant and lactating women. This task will establish glossaries and other explanatory tools for internal and external use and shared with the public. The glossary will specify a standardised nomenclature and terminologies related to use of medicines during pregnancy and lactation that will be used consistently within the project for scientific communication. In collaboration with maternal/patient experts the glossary will include lay terms that can also be used when developing dissemination materials intended for the public.