Speaking at this year’s AAPS in Chicago, the Office of Generic Drugs’ Robert Iser said seeking information about manufacturing outsourced to developing countries is often challenging because it is unclear whether the vendor or the sponsor should respond.
Iser – who is the FDA’s (US Food and Drug Administration) director of the division of chemistry IV – added that is also tricky to find the correct person to share the information.
He said when working with contract manufacturing organisations (CMOs) in developing countries, a good way to avoid confusion is establishing information sharing rules within the service agreement. By doing so, he added, approval in theUScould be speedier.
“Some of the challenges we’ve been facing, especially for outsourced drug products in factories, is that when we communicate who do we get the information from? Who has that information? Who has that knowledge? Who is best to question?” said Iser.
“Maybe that should be part of the agreement in your contract. It’s a matter of re-enforcing the information especially later on in the process.”
Confusion over information sharing is an issue when inspecting changes made to the production process, Iser said. However he added it is even more problematic when a plant switches hands – a common occurrence in the emerging markets.
“How do you transfer that knowledge?” Iser asked. “There’s shared responsibility with those contract sites, it’s about making it clear where that knowledge should come from.”
FDA transparency
For its part, the FDA is also making “significant” efforts to be more transparent in a bid to harmonise the generic approval process over the world.
Icer said in the interests of “common standards” the generics team has been shifting towards ICH (International Conference on Harmonisation) guidelines over the past few years.
“There’s been some real effort there to get everyone on that level playing field,” he said.
“We also are communicating externally a lot more with the industry recently, whether that be through workshops, through trade organisations, through in country training sessions.”
He said that for emerging markets, sending FDA staff to lay out quality standards and expectations over products that will be submitted to theUShas also been a key focus.
“Another effort that we had – and it’s in the process of being revised – is question based review documents which are standard approach to submissions for generic products,” he added.