Situation
Submitting study data to regulatory agencies is a critical step to starting first-in-human studies, and unplanned barriers have the potential to radically delay timelines. Acceptance by regulatory agencies of your data is one potential roadblock, and many countries have requirements regarding the circumstances under which they will accept data packages. Notably, some countries that are members of the Organization for Economic Co-operation and Development (OECD) will not accept data from companies that do not have laboratories that have been inspected by agencies within the OECD.
Challenge
WuXi AppTec had generated data for a client’s drug development program, which was well on its way toward first-in-human studies, in its facilities, located in China. The client submitted the relevant data to the Medicines & Healthcare products Regulatory Agency (MHRA), a United Kingdom regulatory agency, but the agency rejected the application, reasoning that because WuXi AppTec’s laboratories were not located in one of the 36 member countries of the OECD, the agency would not accept study data.
Results
Facing the very real possibility of conducting key pre-IND studies, the client was very concerned that timeline delays would significantly hinder development of their new therapy. However, they were aware of WuXi AppTec’s longstanding history of successful regulatory audits with agencies across the globe, especially in OECD member countries.
The client met with MHRA leadership to discuss the problem, reporting that WuXi AppTec was heavily audited by the U.S. FDA, EMA, and NMPA. MHRA agreed that they would accept data from WuXi AppTec as long as their laboratory had been audited by a major regulatory agency within six months of the studies being conducted.
Solution
WuXi AppTec’s robust audit history allowed us to give the client the details of the most recent inspection the U.S. FDA, which occurred just one month prior to our client’s study completion. This allowed the successful submission of study data, and the acceptance of the IND, allowing the first in human studies to begin in the United Kingdom.
