Abstract

Cooperation is a key element in driving universal health and ensuring patients have access to high quality, effective, safe and innovative medicines. Among various facilitated regulatory pathways for new marketing authorisation applications (MAA), reliance pathways, in the form of collaborative, regional, unilateral and mutual recognition, hold a unique position for regulatory strategists, as they offer simplification and efficiency by minimising the duplication of reviews, leading to faster access to medicines and improved health systems.

Analysis conducted by AstraZeneca shows a positive trend in using reliance and accelerated procedures for MAAs. Submissions and reliance pathways used in more than 100 countries in defined international regions (Asia-Pacific, Eurasia, Latin America, Middle East and Africa) were studied during the period of April 2018 to October 2023. The analysis shows that different MAA reliance pathway naming varies across countries and shows that there is a need for further harmonisation of reliance pathway terminology for MAAs.

To facilitate internal data analysis of the reliance pathways used for AstraZeneca MAA submissions, it was necessary to unify the terminology and establish a lexicon that enables itsregulatory strategists to easily comprehend the various regulatory reliance pathways, based on the World Health Organization (WHO) naming conventions. Consequently, AstraZeneca proposes a streamlined approach to regulatory reliance classifications for MAA procedures to be used by its regulatory strategists.

This article summarises AstraZeneca analysis of available regulations using reliance pathways for MAAs and a proposed reliance pathway classification to streamline strategic considerations for use in MAAs.