The development of pharmaceuticals products is a complex and arduous process. It requires significant investment (both financial and time). The costs of developing products range from $314 million to $2.8 billion, with the time of bringing a new drug to market up to 15 years. The overall probability of success from phase 1 to approval is estimated at between 9% to 12%. Concerns have been raised in the fall off of new approvals and the decreasing number of innovative therapies coming through pharmaceutical R&D divisions. Academia is recognised as a source of such new therapies, but their strengths do not lie in successfully getting product to market. Difficulties arise in the academic setting, due to their lack of understanding and knowledge of the rigorous regulatory requirements that are needed to gain clearance to market pharmaceutical products. Additional tools are needed to aid academic researchers navigate the necessary regulatory pathways. Whilst Technology Readiness Level (TRL) tools exist, they are simplistic in nature and do not provide the necessary detail to facilitate this process. An expansion of the TRL is proposed as one such solution, in the form of a Regulatory Readiness (RRL) tool. This tool will serve as a suitable method to ensure academics have the knowledge and skills to incorporate regulatory science into their product development processes.
McGowran, Eamonn and Harris, Elaine
"Regulatory Readiness Level: a Tool to Enhance Early Regulatory Adoption in Academic Discovery,"
2, Article 6.
Available at: https://arrow.tudublin.ie/level3/vol15/iss2/6
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