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Regulators call for a higherstandard of veterin ary productapplicationAnimal Pharm's 5th annual Regulation of Veterinary Medicines in Europe 2009 conferenceattracted an audience of industry professionals, European regulators and representatives of theanimal health companies to Prague last month. Reporter Barbara Axt travelled to the CzechRepublic to cover the event.

How to deal smoothly withenvironmental assessmentsand reduce the number ofreferred applications were twoof the most discussed topicsof the conference, with otherimportant subjects coveredincluding the process ofapproving generic medicinesand the harmonization ofregulations across Europeanmember states.

Delegates were looking forguidance in learning how tonavigate their way throughthe ever changing Europeanregulations for veterinarymedicines. "We never knoweverything. When you thinkyou've finally learnt it, thelegislation changes again,"commented Irma Middelho{

managing director of R&Dfor Dopharma BV, in theNetherlands.

On the topic of EnvironmentalRisk Assessments (ERA), AlexTait, senior environmentalsafety assessor for theVeterinary MedicinesDirectorate, UK, explainedin detail the workings ofthe new revised Committeefor Medicinal Products forVeterinary Use (CVMP)guidelines. The new set ofrules, which came into effecton March 1st 2009. is basedon the VICH protocol, anagreement between the EU,Japan and the US aimedat harmonizing technicalrequirements for veterinaryproduct registration.

Dr Tait gave advice on howto reduce the approval timeand the need for referralsby producing an effectiveERA report. "For phase 1, Isuggest. applicants includeshort reports explaining thephysical-chemical propertiesof the active substance.instead of providing onlyyes/no answers," he toldAnimal Pharm. "These can bereally short reports, just oneparagraph long."

"For the phase 2, the biggestdiffrculty is for the genericdrugs, as in some casesapplicants use literaturethat already exists, but thatmay not be specifrc to thatactive substance, or provideinsufficient detail," he said."It's important that the studyis carried out conformingto the protocol and currentguidelines." This observationwas echoed by Gesine Hahn,manager of the Federal Officeof Consumer Protection &Food Safety in Germany, who ,noted that: "Some applicationsfor generics are based onproducts that were approveda long time ago, and accordingto standards that are not validanymore."

Dr Tait concluded: "In short,make a report that doesn'tIeave any room for discussionbetween regulators."

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Regulatory overviewRegarding more wide industryissues, an overview oftheregulatory landscape inEurope was presented by IngeSandberg, technical directorof EGG\?, the Brussels-basedgeneric industries association,which comprises 22 members.She explained in detail thechanges in the regulationsand EU guidelines taken placeover the last few years. aimingto improve the process andharmonize regulations in allEuropean countries. However,she highlighted it's not asimple task. "In 1965, Europestarted the harmonizationof regulations for humanmedicines. The process forveterinary medicines began in1985," she explained.'As youcan see, we still have a longway to go."

"Our history is the greatestobstacle for harmonization.For a long time, Europeancountries have had their ownway of working, and you stillsee that today. People tend tohold on to the old methods, soit's very difficult to implementthe new directives," she added.

EU harmonizationThe different regulations andinterpretations among memberstates are one ofthe reasonsfor the increasing number ofreferrals, as Esther Werner,head of Veterinary Bacteriologyat the Paul-Ehrlich Institutin Germany, mentioned inher paper. An applicationsubmitted to several Eurooean

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countries is sent to referralwhen the countries cannotagree in a common verdict. Thereferral process is relativelynew, having been implementedin 2005.

However, Dr Werneralso observed that manyapplication dossiers are notas complete or detailed asthey should be. 'Applicationsfor immunological productssometimes don't have enoughinformation regarding theefficacy of the product,"she said. "Some companiesuse so few animals that itcompromises the results of theresearch."

Cost effectivenessFrom the manufacturers'point of view, representativeswarned that the complexitiesand costs ofthe applicationprocess for new medicines,together with tougherenvironmental regulations,could make the developmentof medicines for minor speciesnot worth the effort.

'As i t takes longer and costsmore money to approvernedicines, there is a riskthat smaller markets, suchas drugs for horses or bees,will be forgotten," saidMetka Bertalanic, head ofregulatory affairs for NovartisAnimal Health in Slovenia.She also noted that therequirements for EnvironmentRisk Assessments make thecompanion animals marketeven more profrtable, as theenvironmental impact of

Soeaker Pascal Richez

treating dogs on an individualbasis cannot even be comparedto that oftreating thousandsof anirnals simultaneouslyin a farm. Ms Bertalanicalso observed as a trend that"Legislation is allowing lessand less interpretation."

A different trend formedicines was pinpointed byPascal Richez, chairman ofTranspharm, in France, duringhis presentation. "Topicaldrugs are becoming morepopu lar in human med ic ine . sowe can expect registrations ofsuch medicines to increase inveterinary health as well."

Electronic dossiersOther papers discussedhow non-standard testingmethods can help refine theresults of ERA. reducinguncertainty; and the processof replacing the paper dossiersthat are currently used forapplications by e-dossiers.Per Helboe, senior directorof the Licensing DivisionDepartment for DanishMedicines, in Denmark, talkedabout how these dossiers canwork, what are the guidelinesfor formats, media, and themain security issues thathave to be solved beforethe whole process becomeselectronic. From January 1st2010 European agencies haveto be fully prepared to acceptelectronic dossiers. However,manufacturers can stilluse paper dossiers for therrapplications, if they wish.

Conferencevideos!

See videos ofkey speakers atthe Regulation of VeterinaryMedicines in Europeconference.

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Esther Werner. chair of CMDV

Inge Sandberg, EC'GUPtechnical director

3 April 2009 '. Animal Pharm

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[ffiAlex Tait of the