European regulators are following the example of FDA colleagues by introducing a new program to speed up development of drugs for underserved diseases.
Under the program called PRIME (priority medicines), innovating development programs are given a push to introduce them to the regulator’s radar. By doing this it is hoped that traditional causes of delay, such as lack of early feedback on development plans, can be eliminated and this should also reduce costs for wasted lines of study trials.
The program mimics the FDA program called “breakthrough” started in 2012 which currently has some 110 such programs in it’s system and 30 approval successes.
With the UK stating a similar program in 2014, is this another opportunity for regulators to share data and outcomes to make this globally efficient? Perhaps what’s required is an ICH type summit to help bring this about. Thoughts?
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