The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval changes for non-complex generics as current versions are outdated, according to representatives of the generics industry.
The remarks were made during a panel on post-approval changes for complex generics on 9 November at the Association for Accessible Medicines’ (AAM) GRx+Biosim held a conference in Bethesda, MD.
“The current regulatory guidelines do not provide complete details as to the data requirements and regulatory filing categories for post-approval changes for complex generics,” said Michael Balon, global director for regulatory affairs at Apotex.
For example, FDA’s existing suite of post-approval guidances do not address the transfer and scale-up of metered dose inhalers (MDIs), dry powder inhalers (DPIs), nor do they address component changes for such products.
FDA also needs to update their guidances on post-approval changes for non-complex products, asserted Janet Vaughn, the vice president for North American generic regulatory affairs for Teva Pharmaceuticals…
