Making the Most of Paediatric SPC Extensions
11 July 2007
Regulatory Affairs Journal, Pharma, July 2007, 459-463
Authors: Mike Snodin and John Miles
This article appeared in the July 2007 edition of Regulatory Affairs Journal, Pharma. It is the first article to ever propose the revolutionary concept of zero or negative term SPCs. Mike and John argue that the acceptance of such SPCs is necessary in order to enable those conducting clinical trials in the paediatric population to benefit from a reward (a six-month extension of SPC term) provided by Regulation (EC) no. 1901/2006.