CVM/European Medicines Agency (EMA) Exchange of Experts – 2012
The EMA and CVM exchanged experts to develop a better understanding of each agencies processes/procedures. Hilde Boone and Mireia Castillon, EMA, developed an itinerary for CVM’s International Programs, Dr. Michael Oehlsen’s, visit which included meeting with experts and groups in the EMA (EU GMP/GDP and CVMP), as well as the Veterinary Medicines Directorate (VMD) in the United Kingdom. Dr. Oehlsen spent a period of two weeks (September 1-15, 2012) in the UK to initiate the expert exchange and was able to participate in several internal meetings in both the EMA and VMD. The meetings included but were not limited to several Eu Member State committee meetings as well as break-out sessions with both Eu members and EMA staff. As a follow-up to Dr. Oehlsen’s visit, Dr. Kornelia Grein, Head, Veterinary Medicine - EMA, travelled to the United States for a two week visit in November 2012 at CVM.
Dr. Kornelia Grain shared with CVM background and useful information about the business operations of the EMA. The European Medicines Agency (EMA) is a decentralized agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. Dr. Grein’s visit to CVM helped strengthen our current bilateral relationship in the areas of GMP/GDPs, an overall understanding of both the authorization processes, as well as the exchanges of inspectional reports and confidence building (relative to the document recently published "Enhancing GMP Inspection Cooperation with FDA - Moving from confidence-building in to reliance upon") on the information contained within each report. Thus far, CVM has completed a Pilot API GMP program (piggy-backing CDER's pilot program) with the successful multi-agency joint inspection of a US based facility. Since that time, CVM has actively exchanged a total of Six inspectional reports that were used in the review of NADAs by ONADE review staff. The exchange affords both agencies with a better understanding of the overall regulatory processes and has strengthened our understating of the GMP inspection for both agencies. This, in turn, has enabled the information provided in the cGMP reports to be better understood by CVM review staff and used in their review of Animal Drug Applications.
As part of Dr. Oehlsen’s visit to the EMA, he was able to attend a meeting of The Committee for Medicinal Products for Veterinary Use (CVMP). CVMP is the European committee responsible for preparing the EMA’s opinion(s) on all questions concerning veterinary medicines. It does not currently publish the minutes or agendas of its meetings; however, it does publish a meeting report after each meeting. The information shared with Dr. Oehlsen was transferred to the staff at CVM via a presentation given later that year and later reinforced with information provided to CVM staff by a presentation given by Dr. Grein.
Dr. Oehlsen’s visit with the Veterinary Medicines Directorate (VMD) was to “kick-off” our newly signed (2011) Confidentiality Agreement by sharing with VMD officials a background and general overview of CVM's current activities to include current practices, policies, and procedures in the fields of animal drug approval processes, the potential inclusion of VMD into the innovative technologies WG (led by CVM), GMP inspectional procedures/policies for the potential of inspectional report exchange, as well as generate a communication pathway in which we can establish regularly scheduled bilateral meetings for the exchange of scientific information. The visit to VMD was led by Director General, Peter Borilleo. A secondary trip to the Animal Health and Veterinary Laboratories Agency (AHVLA) was completed on the second day of the two day trip to the VMD (Sept 6-7, 2012). AHVLA is an executive agency working on behalf of the Department for the Environment, Food & Rural Affairs (Defra), Scottish Government, and Welsh Government. The agency was formed following the merger of Animal Health and the Veterinary Laboratories Agency on 1st April 2011. The primary role of the agency is to safeguard animal health and welfare as well as public health, protect the economy, and enhance food security through research, surveillance, and inspection. In addition to its role in Great Britain, the agency also acts as the national, European, and international reference laboratory for several exotic and zoonotic notifiable diseases. Dr. Borilleo is scheduled to visit CVM in June 2013, where he will meet with Dr. Jeff Gilbert and Pat McDermott to discuss Anitmicrobial Resistance and the National Antimicrobial Resistance Monitoring System. Dr. Borilleo’s visit to the U.S. is yet another step towards CVM’s active role in promoting and sustaining FDA’s Globalization Initiative.