International Approach for Veterinary Medicinal ... - Middle East - OIE

OIE Conference on VeterinaryMedicinal Products in theMiddle EastDamascus, Syria, 2-4 December 2009International Approach for VeterinaryMedicinal Products: VICHBarbara Freischem, IFAH

OverviewRegulatory Infrastructure and the role of VICH– Regulation of veterinary medicines – need for,advantages and costs of regulation; basic framework– Role of VICH in the regulation of veterinary medicines– Success of VICH and relevance to the Middle East2

Regulation of Veterinary Medicines– role of VICHLegislative framework regulating veterinary medicines (VMs)Authorisation of VMs• Pre-marketing requirementsfor quality, safety & efficacyVICH• Dossier submission• Application evaluation• Authorisation decision –approval / non-approvalControl of VMs• Pre-authorisation– GMP inspection of manufacturer• Post-authorisation– GMP-inspection of manufacturer– Inspections for other obligationse.g. pharmacovigilance– Random quality control of VMson the market5

VICH regionsCanadaEuropeUSAJapanAustraliaNew Zealand7

VICH objectives• Establish and implement harmonized regulatory requirements forveterinary medicinal products in the VICH Regions, which meet highquality, safety and efficacy standards and minimize the use of testanimals and costs of product development.• Provide a basis for wider international harmonization of registrationrequirements.• Monitor, maintain, and, where necessary, update existing VICHguidelines.• Ensure efficient processes for maintaining and monitoringconsistent interpretation of data requirements afterimplementation of VICH guidelines.• Provide technical guidance enabling response to significantemerging global issues and science that impact on regulatoryrequirements within the VICH regions by means of a constructivedialogue between regulatory authorities and industry. 8

VICH structure and process•The program: a trilateral (EU-Japan-USA) programmeinvolving regulators and industry aimed at harmonisingtechnical requirements for veterinary product registration;Australia/New Zealand and Canada are observers .•The Driver : The Steering Committee with representativesfrom all parties of the VICH regions and observer countries•The Process: the 9-step procedure•The Framework: the official Organisational Charter•The Workers: the Expert Working Groups (EWGs); madeup of members from all VICH parties and observers•The Support: the VICH secretariat provided by IFAH9

VICH topics•Quality•Safety•Ecotoxicity•Good Clinical Practice (GCP)•Anthelmintics•Pharmacovigilance•Biologicals quality monitoring•Antimicrobial resistance•Target Animal Safety•Metabolism and Residue Kinetics10

The VICH 9 – Step ProcedureStep 1Step 2Step 3Step 4Step 5Step 6Step 7-8Step 9• Concept paper to propose issue• Review by SC• Appointment of Topic Leader/ChairmanEWG to produce draft GuidelineSC to review draft GuidelineOfficial consultation in three regionsEWG to review commentsSC to adopt final GuidelineImplementation of GuidelineMonitoring, maintenance & recommendation for review11

VICH – what can it do and not do?VICH does:• harmonize test requirements forthe authorisation of veterinarymedicines;• ensure that test requirementsare based on the current state ofscience;• reduce need to repeat studies –full VICH partners commit toaccepting studies performed toVICH GLs, observers voluntarilyaccept;• support animal welfare by widerstudy acceptance and reducingneed for test animals.VICH does not:• provide a legislative structure forregulatory system for veterinarymedicines;• harmonize the interpretation oftest results;• guarantee authorisation, even ifall tests are done in accordancewith VICH GLs;• harmonize all areas of testingveterinary medicines – onlywhere there is an agreed needof regulators and industry ofVICH regions and observers.12

VICH - has it worked?Yes• An excellent forum for continuing dialogue and collaborationbetween research based animal health industry and regulatorybodies around the world• 3 public conferences building confidence into VICH held since thestart, the 4 th comes to the OIE headquarters, Paris, 24-25 June 2010• Regular meetings between assessors working towards aconsensual approach to assessment and scientific evaluation ofregulatory submissions• Over 40 guidelines finalised on a broad range of topics coveringquality, safety & efficacy• Overwhelming agreement that VICH has helped to streamline theapproval of veterinary medicines in participating countries13

Does VICH have relevance for theMiddle East?• YES - very definitely! – if only to encourage the legal sector• Implementing VICH guidelines– can help align regulatory systems in the Middle East to globalsystems for approving veterinary drugs– will provide access for assessors to the latest scientific thinking ondossier evaluation– can provide a platform for regional regulatory harmonization• Adopting pharmacovigilance principles will provide detailed andvaluable post authorisation information on safety of medicines• VICH is evaluating the needs of non-VICH countries and consideringpossibilities for involving new regionsthe focus of the VICH 4 conference; come and bring your ideas!14

Further InformationOn IFAH @ http://www.ifahsec.orgOn VICH @ http://www.vichsec.org,including theVICH 4 conference24-25 June 2010,OIE headquarters at12, rue de pronyParisThank you for your attention15