Rethinking emerging markets for regulatory affairs with the creation of a Regulatory Authority Development Index

Article on Rethinking emerging markets for regulatory affairs with the creation of a Regulatory Authority Development Index 

Authors: Alan Morrison, VP International Regulatory Affairs and Safety, Amgen Ltd, Cambridge, UK; Romi Singh, Executive Director, Regulatory Affairs and Safety, Amgen Ltd, Thousand Oaks, CA, US.  Regulatory Rapporteur April 2012, TOPRA.

This article discusses the concept of the “emerging market” and the associated terminology that has evolved historically to what is being currently used. Countries or regions can be classified as “emerging” or “developing” according to a raft of different criteria such as economic status, industrial development, relative level of per capita income, human development index, etc. From the perspective of the biopharmaceutical industry, most of the major companies have either created or reorganised their groups to focus on emerging markets based on the market size or commercial potential of a region rather than by its regulatory systems. From a regulatory science perspective, historically markets are classified as “primary” or “secondary” depending on the level of data submitted in the registration dossier. The “emerging markets” label may not be applicable for regulatory sciences. Thus, an initiative has begun to create a Regulatory Authority Development Index (RADI) as a measure of the “regulatory sophistication” of a regulatory authority. This index will be generated through the measurement of various factors such as transparency, review/approval efficiency, consistency, clarity, effectiveness, lack of barriers, etc.

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Rethinking emerging markets for regulatory affairs with the creation of a Regulatory Authority Development Index