1.5. The current status of submissions and work sharing programs in the USA and Europe

FDA started its CMC Pilot Program in July 2005 offering participating firms an opportunity to submit/share QbD elements in CMC sections of regulatory submissions. Out of the target number of 9 original and 2(3) supplemental NDAs were accepted, and 11 are by now approved (1 was withdrawn for non-CMC reasons). Since then the number of QbD containing applications of new drugs has increased over the past 6 years, according to FDA communication during a workshop with EMA and ICH in July 2011, with approximately 6 to 9 QbD applications per year since 2008 cumulating in a total number of almost 50 NDAs that included at least some level of QbD.²⁰

In Europe the EMA has received 18 (4 incl. RTRT) initial MAAs for chemical entities and 2 for biologicals by 2011, but none for a generic drug application.

In order to increase assessors’ awareness using actual applications and to ensure a consistent implementation of ICH Q8-10 concepts into the evaluation process in the EU and the USA, the EMA and FDA have now started a pilot for parallel assessment of QbD applications (NCE products only).²¹

²⁰ Miksinski; FDA Perspective; 2011
²¹ Koiakiniti E.; European Union (EU) Perspective; 2011