What products will be affected by the Food and Drug Administration’s (FDA) quality by design (QbD) stipulation, as outlined in its report, “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”?

It will apply to new marketing authorization applications, new drug applications, Type II variations, and prior-approval supplements. It will apply to scientific advice requests and chemistry, manufacturing, and controls formal-meeting requests that include QbD or process analytical technology elements and are submitted to the FDA and European Union as new applications. And it will apply to marketing authorization applications and new drug applications where the sponsor or applicant has agreed to a parallel evaluation by both agencies.

Upon request from the sponsor or applicant, and where procedural timelines will allow, Type II variations and new drug applications may also be considered on a case-by-case basis. Right now this is a voluntary pilot, although some pharma companies are being tapped or nudged by the FDA and the European Medicines Agency (EMA) to join in.

 …