control of veterinary products: the need for global standards dr. jean-pierre orand
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Control of veterinary products: the need for global standards Dr. Jean-Pierre Orand Collaborating centre for veterinary medicinal products Anses /ANMV BP 90203 - 35302 FOUGERES CEDEX, FRANCE [email protected]. Introduction. - PowerPoint PPT PresentationTRANSCRIPT
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Control of veterinary products: Control of veterinary products: the need for global standardsthe need for global standards
Dr. Jean-Pierre Orand
Collaborating centre for veterinary medicinal products Anses/ANMV
BP 90203 - 35302 FOUGERES CEDEX, FRANCE [email protected]
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Introduction
Veterinary Medicinal Products (VMPs) :Veterinary tools, contributing to the improvement of animal
and public health worldwide, and of food security
The VMPs policy as part of the animal health policy
Need for Efficacy, safety and quality of VMPs
Need of a strong legislative and regulatory framework implemented through a strong and comprehensive governance linked to national veterinary services
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OIE-VICH Mains results
Questionnaire sent in June 2009 to OIE Members
2 months consultation
91 answers covering 88 Member countries– 26 from VICH countries– 62 from non VICH countries
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2950
49
13
26
176 Member Countries (2010) 88 answers
Americas: 13/29 – Africa: 24/52 – Europe: 29/53 – Middle East: 6/20 Americas: 13/29 – Africa: 24/52 – Europe: 29/53 – Middle East: 6/20 – Asia: 16/35– Asia: 16/35
24
13
29
6
16
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Human Development Index. United Nations
Description English: The United Nations Human Development Index (HDI) rankings for 2008. 0.950 and Over 0.900–0.949 0.850–0.899 0.800–0.849 0.750–0.799 0.700–0.749 0.650–0.699 0.600–0.649 0.550–0.599 0.500–0.549 0.450–0.499 0.400–0.449 0.350–0.399 under 0.350 not available
The Human Development Index (HDI) is a comparative measure of life expectancy, literacy, education and standards of living for countries worldwide. It is a standard means of measuring well-being, especially child welfare. It is used to distinguish whether the country is a developed, a developing or an under-developed country
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4 Levels of Development
Very High
High
Medium
Low
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9 countries have no legislation in place– 2 - Low– 5 - Medium– 2 - High– 0 - Very High
Legislation in Place
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Legislation in place
Manufacturing
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Legislation in place
Pharmacovigilance
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Legislation in place
Inspection
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Infrastructure in place
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OIE-PVS can Help to establish a diagonostic
Section II-9 Veterinary medicines and veterinary biologicals Veterinary medicines and veterinary biologicals
The authority and capability of the VS to regulate veterinary medicines and veterinary biologicals.
Levels of advancement Suggested indicators
1. The VS cannot regulate the usage of veterinary medicines and veterinary biologicals.
2. The VS has only limited capability to exercise administrative control (including registration) over the usage, including import and production, of veterinary medicines and veterinary biologicals.
Documented administrative process, including for setting fee-for-serviceRegistration dossiers for import and productionRecords on performance of these functions
3. The VS exercise quality control (technical standards) over the import, production and distribution of veterinary medicines and veterinary biologicals.
Documented quality control procedures and results of controlsInformation on adverse findings and action taken Dedicated staff and/or equipment
4. The VS exercise complete control over registration, sale and usage of veterinary medicines and veterinary biologicals.
Documented procedures for and evidence in regard to the collection of samples, including results, and decision making in response to findings
5. The VS implement systems to monitor the use of veterinary medicines, veterinary biologicals and their side effects (pharmacovigilance).
Legislation and procedures for the control of VM and VB distributionEvidence of the systematic collection of relevant information and decisions in response to findings
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Legislative and regulatory requirements
1. Public policy
2. Activities to be covered
3. Institutional organisation
4. Penalties and administrative action
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Legislative and regulatory requirements
1. Public policy Written mandate with proportionate objectives and strong
commitment to ensure efficiency, competence and impartiality
2. Activities to be covered All activities along the entire life of VMPs from development to
usage, including residues aspects
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Activities to be covered (All, from manufacturing to usage)
Manufacturing – Good Manufacturing Practice (GMP)– inspections to assure GMP compliance…
Registration– Establish transparent, effective laws and standards for drug
registration– Regulate imports, clinical trials– Maximum residue limits setting– Implement market surveillance Pharmacovigilance, advertising– Ensure transparency …
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Activities to be covered (All, from manufacturing to usage)
Control – Of Veterinary medicinal products– Of residues
Distribution– Regulate allocation, transport, and storage of drugs– Secure appropriate storage facilities and transport…
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Activities to be covered (All, from manufacturing to usage)
Use– Develop and engage professional associations to improve
adherence to professional codes of conduct– Impose penalties for breaches of legal and ethical standards– Regulate industry interaction with prescribers…
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Legislative and regulatory requirements
3. Institutional organisation
Scope of responsibilities and mission statementScience based decision making processHuman resources Fee systemTransparency and communication responsibilities
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Inspectorate Body
Need for an approach in terms of inspection on the whole chain of VMPs
Inspectorate body should be given the necessary ressources : legal and technical– Inspectors : Power
Duties
Qualifications– Transparence and communication : procedure, accreditation
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Legislative and regulatory requirements
4. Penalties and administrative actionAdministrative capacities of national competent authorities
The mechanism should be backed (where necessary) by Administrative sanctions as
– Recall and destruction of products– Suspension or withdrawal of product, manufacturing or
other licences
To correct anomalies with a potential impact on health
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Legislative and regulatory requirements
4. Penalties and administrative actionProsecution capacities :
• Penal measures for Repeat offending, Counterfeiting, fraudulent intent
• For most serious situation • Fall under the relevant jurisdiction (a judge)
Coordination among official services
Transparency and communication
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Legislative and regulatory requirements
4. Penalties and administrative actionRole of statutory bodies
• The system relies also on the involvement of statutory bodies in
– Developing guidelines and ethical standards– Improving adherence to professional codes of practices /
conduct.
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OIE Strategy for Veterinary Products based on complementary approaches :
Development and updating of international standards and guidelines• All aspects detailed about VMP governance will help in developing general or
specifics standards
Capacity building : legislation, infrastructure and administrative capacities
• Modernisation or updating of national legislation– OIE Guidelines for Veterinary Legislation are essential elements to be covered
in veterinary legislation– Promote regional cooperation
• Support to Veterinary Services – PVS tool may be developed to VMPs governance (section II-9)
• Support to laboratories (national/regional)
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Communication and training• Organization of regional conferences (Dakar 2008, Damas
2009) • Training of focal points (Serbia, colombia, South Africa)
Collaboration and cooperation with international organisations
• CCRVDF, Task Force of AMR• VICH
OIE Strategy for Veterinary Products based on complementary approaches:
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12 rue de Prony, 75017 Paris, France - www.oie.int – [email protected]
Organisation mondialede la santé animale
World Organisationfor Animal Health
Organización Mundialde Sanidad Animal
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