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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.
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Regulatory News | 11 June 2015 | By Michael Mezher
The European Medicines Agency (EMA) has released a new set of recommendations for postmarket surveillance for veterinary medicinal products, which will go into effect on 1 October 2015.
Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. For veterinary populations, regulators, companies and veterinarians are responsible for monitoring drugs and reporting suspected adverse drug reactions (ADRs). This information is incredibly important to ensuring both animal and human safety after a product has been approved.
The legal basis for pharmacovigilance activities in the EU can be found in Article 47 of Regulation (EC) No 726/2004 and Article 87 of Directive 2001/82/EC. Additionally, specific guidelines for veterinary pharmacovigilance activities can be found in Volume 9B of The rules governing medicinal products in the European Union.
While pharmacovigilance is a vital part of ensuring a product's safety after it enters the market, regulators around the world have struggled with under-reporting of adverse events. In Europe, under-reporting of adverse events is a significant issue, especially in food-producing species. Despite more than half of centrally authorized veterinary medicines being licensed for use in food-producing species, less than 1/6th of adverse event reports (AERs) are in reference to adverse events in food-producing species.
According to EMA, its goal in drafting its new recommendations is to "provide an initial framework that will allow further development of signal detection in veterinary pharmacovigilance."
With the advent of new electronic veterinary pharmacovigilance databases covering larger swaths of territory, regulators and companies have the potential to use more powerful "statistical and data mining techniques to support surveillance." However, there are important distinctions between pharmacovigilance for veterinary and human populations to take into account:
"a single adverse event report in animals may involve several animals. In some cases, a whole group or herd may be affected by herd treatment. Therefore, a "case report" does not necessarily refer to a single affected animal. Data can therefore be analysed by grouping the events of all animals involved in the same case report or by taking into account each animal by showing a particular sign;Some events are specific to the use of veterinary medicines and are subject to reporting in the same way as adverse events e.g.: investigations of the validity of the designated withdrawal period, environmental problems;The global amount of available data is still limited as the pharmacovigilance system for veterinary medicines is not as extensive and has not been running for as long as for human pharmacovigilance."
Similar to human pharmacovigilance, signal sources for veterinary adverse events can include data from AERs, scientific literature and other post-authorization procedures such as variations and renewals. Regulators and companies are also increasingly looking to "new media," including social media and websites as a signal source for adverse events.
However, EMA cautions that the quality of information gleaned from "new media" sources is low and poorly understood, but says the agency is looking into developing "further specific guidance regarding the use of information available for these sources."
EMA also makes specific recommendations for each step along the signal management process, which are explained as follows:
"Detection of potential signals;Signal prioritization: to promptly identify signals with important animal and/or public health impact or that may significantly affect the benefit-risk balance of the medicinal product in treated animals;Signal validation: review of the case reports that generated the signal, to check if sufficient information exist to justify further evaluation;Signal evaluation: review of the pharmacological, pre-clinical, clinical, epidemiological data from various sources, in order to conclude on a causal association, to quantify it and to identify the need for additional data collection of for risk minimization measures;Recommendation for action: to consider at any stage of the signal management process."
Finally, the document discusses factors to consider in determining whether a product should be subject to more intensive monitoring. These factors include how long an active substance has been authorized, the type of product, risk to humans and potential environmental problems.
Tags: Pharmacovigilance, Signal management