By Oliver Cox and Siegfried Schmitt, PhD
Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and expectations, and discussions with peers in the regulatory community. There are many strands to consider when looking to the future in regulatory affairs.
The first strand is the regulations and how these are likely to be impacted by a globalized regulatory healthcare authority and interpretation by various stakeholders. The second strand is the world’s response to public healthcare challenges in an increasingly interconnected environment. With limited investment incentives, these public healthcare challenges may take a back seat to other research and development (R&D) priorities across the pharmaceutical industry. And lastly, as the pharmaceutical market searches for that next blockbuster and as R&D pushes scientific frontiers, the regulations will have to change to keep pace—not only with more-complex therapies but also with the drive to develop individualized medicines.
Cox O, Schmitt S. “Looking to the Future in Regulatory Affairs.” Regulatory Focus. January 2014. Regulatory Affairs
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