Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 20 March 2015 | By Michael Mezher
Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting.
EMA, along with national regulators, is tasked with monitoring and collecting post-market surveillance data on veterinary medicines. This is done primarily through the submission of adverse event reports (EARs), which are submitted to the agency from a variety of sources, including marketing authorization holders, veterinarians, breeders and animal owners.
The legal basis for EMA’s pharmacovigilance activities is found within Article 47 of Regulation (EC) No 726/2004 and Article 87 of Directive 2001/82/EC. These articles establish EMA’s responsibility to work with national regulators to monitor adverse reactions to veterinary medicinal products. The specific guidelines for veterinary pharmacovigilance activities can be found in Volume 9B of The rules governing medicinal products in the European Union.
The EU is also considering several across-the-board changes to its veterinary medicines regulations, including proposals that would overhaul Regulation (EC) No 726/2004 and Directive 2001/82/EC. Additionally, EMA is participating in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and has adopted several VICH guidelines on pharmacovigilance standards which will go into effect at the end of 2015.
The new reflection paper is intended to address the issue of underreporting of adverse events, especially for medicinal products used to treat food-producing species.
EMA says that more than half of veterinary products approved through the centralized procedure are licensed for use in food-producing species. However, in 2013, only 13.6% of AERs for animals were in reference to adverse events in food-producing species. While the overall number of AERs for food-producing species rose in 2014, the proportion remains low at 11.6% of all animal reports.
To address this issue, EMA suggests that member states develop relationships with industry groups and professional bodies.
EMA also recommends for member states to clarify how adverse events are handled, and stresses that “any unexpected clinical sign observed in animal ... is potentially an adverse event.” The agency says that this information is essential for it to make updates to product information in the future.
To encourage overall adverse event reporting, the agency is suggesting a series of measures that could be implemented.
The first suggestion the agency is proposing is to streamline how feedback is given to adverse event reporters. Presently, there is no standard to give feedback on AERs, and in some cases reporters may receive similar feedback from multiple agencies. To address this, EMA suggests the possibility of distributing overviews of the reports it received that could be distributed annually to adverse event reporters.
Several of EMA’s suggestions involve improving the technology for adverse event reporting, including developing tools that could be used with existing veterinary practice management software and building smartphone and tablet applications for submitting adverse events.
EMA is also weighing several communications strategies to promote adverse event reporting, such as using social media to spread awareness to veterinary practitioners and building an EU-wide pharmacovigilance bulletin that would link users to various member states’ pharmacovigilance reports and websites.
EMA Reflection Paper
Tags: Adverse Event Reporting, AERs, Food-producing animals, CVMP, VICH