The European regulator outlined its network 2020 strategy today, explaining it plans to work with national drug agencies to oversee pharmaceutical supply chains in a bid to eliminate duplicate inspections.
The EMA said: “The complexity of international supply chains present risks of errors and occasionally counterfeits or product diversion” adding that it is vital all steps in the supply chain are adequately controlled and monitored.
“Sharing of information between regulators responsible for oversight of different manufacturing stages and ensuring that the same standards are applied irrespective of manufacturing location will help minimise possible problems.”
The agency said it will also work to make sure drug and ingredient quality data is accurate, explaining that: “The integrity of the data in the studies used to support market authorisation is fundamental to trust and confidence in the products themselves.
“The network will work with global partners to address the challenges posed by increasingly complex supply chains, global industries and falsified and counterfeit medicines” the EMA said, citing supplier identification and databases as areas that will be “explored.”
Trade deal quality
The EMA stressed the importance of working with the World Health Organisation (WHO) to drive convergence of manufacturing standards around the world, particularly in key supply hubs like India and China.
The agency also suggests international trade agreements – TTIP, CETA and free trade agreements with Japan and Singapore – provide a way of promoting European good manufacturing practices (GMP) and distribution standards.
“The network will explore the opportunities presented by draft trade agreements and other mechanisms to promote greater mutual reliance on inspection outcomes in both, human and veterinary medicines” it said, adding that strengthening mutual reliance agreements will help it make best use of resources.
The agency gave the example of generic drugs as one area in which collaboration is likely, citing information sharing pilot programmes as areas of expansion.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) told us it is still reviewing the EMA strategy document.