Europe – Prospective dialogue between developers and regulators makes for better evidence generation

EMA, in collaboration with other parties, has recently published two scientific articles outlining the importance of early interactions as an opportunity to improve the generation of evidence required for bringing innovation to patients.

An article, published in the British Journal of Clinical Pharmacology, analyses the importance of early advice for the generation of robust evidence after authorisation, once a medicine is used in clinical practice. Post-licensing evidence is often requested by European regulators following the approval of a medicine, to complement the understanding of a medicinal product‘s benefit–risk profile. This includes approvals using early access tools such as conditional marketing authorisation, or products which target rare diseases or are advanced therapies. Health technology assessment (HTA) bodies also see a role for the generation of post-launch evidence to address uncertainties identified during the clinical development. Applicants should have a robust plan for post-licensing evidence generation when they file their marketing authorisation application to increase the confidence of decision‐makers that knowledge gaps can be filled in a reasonable timeframe…