Generic drugs have a long standing tradition in our health care system. They are in place to reduce cost and allow innovation in drug development. Generic drugs can access the market when bioequivalence of the active substance to the innovator drug has been proven, following certain pharmacokinetic principles.
Generic drugs in society, the regulator’s dilemma
Ongoing complaints about efficacy and safety of generic drugs appear in the media, starting with antiepileptic drugs more than a decade ago. In particular switching from innovator to generic or from generic to generic is considered problematic both by consumer and prescriber. It has challenged the regulator how to preserve the validity of the bioequivalence principle, and, as important, how to communicate trustworthy to society.
How can regulatory science contribute to current knowledge and new insights?
It appears that regulatory authorities take different approaches. The question that is put forward in this symposium is how regulatory science can contribute to current knowledge and is able to pave the way to new insights that strengthen regulatory decisions, understandable in today’s society.
The knowledge of the world is only to be acquired in the world
The CBG-MEB Science Day is organized to promote and share our endeavors in regulatory science with our collaborating (academic) partners and to enhance knowledge and network building: ‘The knowledge of the world is only to be acquired in the world and not in the library’ (after Lord Chesterfield 1694-1773)’.