European Technology Platform for Global Animal Health

1
European Technology Platform for Global Animal
Health

• Strategic Research Agenda
• Chapter 6
• Regulatory Issues

2
Ch 6 Regulatory Issues

• Veterinary Medicines
• Pathogen strain variation
• Guidelines
• Data requirements
• Animal Testing
• Diagnostics
• Regulation
• Fit for purpose
• Societal Acceptance

3
Enablers

• Better implementation of harmonised regulatory
  requirements e.g. Centralised procedure and the
  new decentralised procedure
• Defined fast track approaches for EU wide
  Marketing Authorisations for products for
  epidemic disease
• Defined and predictable Minor Use Minor Species
  (MUMS) procedures
• Rapid regulatory procedures to allow for a
  changing vaccine composition in the face of
  actual epidemic strains (AI, FMD)
• Important for Regulatory authorities to be an
  integral part of the process from innovation to
  delivery
• Ensure academia and small/medium sized
  enterprises are aware or regulatory requirements
  to better design their research programmes to
  inform the final regulatory assessment.

4
Other areas

• The need to develop Minor Use Minor Species
  (MUMS) requirements in the European legislation
• Requirements for use of vaccines against
  emergency animal diseases
• Definition of minimum safety and efficacy
  requirements for emergency vaccines
• Development of predictable and consistent Risk
  Analysis and Risk Management Models
• Identify inconsistencies in animal health
  policies at EU level (Registration requirements,
  vaccination policies, trade policies, sanitary
  policies in case of emergency situation)
• Analyse differences between EU and US approaches
  to veterinary medicine regulation

5
Research Agenda I

• 6.3.1 Undertake an assessment and comparison of
  the different drivers for regulation of
  veterinary medicines as compared to human
  medicines in order to design specific research
  programmes to better support the specific
  requirements of the veterinary regulatory
  environment.
• 6.3.2 Research into the value, use, impact and
  lessons learned from the practical experience of
  technical guidelines and monographs in order to
  ensure that guidelines and monographs remain
  appropriate to developing scientific knowledge.

6
Research Agenda I

• 6.3.1 Undertake an assessment and comparison of
  the different drivers for regulation of
  veterinary medicines as compared to human
  medicines in order to design specific research
  programmes to better support the specific
  requirements of the veterinary regulatory
  environment.
• 6.3.2 Research into the value, use, impact and
  lessons learned from the practical experience of
  technical guidelines and monographs in order to
  ensure that guidelines and monographs remain
  appropriate to developing scientific knowledge.

7
Research Agenda II

• 6.3.3 Develop an effective risk-based
  methodology to define the risks and benefits in
  the use of veterinary medicines with the intent
  to use the model to make risk-benefit based
  decisions and determine the testing required for
  new products to underpin this approach.
• 6.3.4 Initiate coordinated action to identify
  the research needed to reduce animal testing by
  either using alternative methods or by reducing
  the testing required.

8
Research Agenda II

• 6.3.3 Develop an effective risk-based
  methodology to define the risks and benefits in
  the use of veterinary medicines with the intent
  to use the model to make risk-benefit based
  decisions and determine the testing required for
  new products to underpin this approach.
• 6.3.4 Initiate coordinated action to identify
  the research needed to reduce animal testing by
  either using alternative methods or by reducing
  the testing required.

9
Research Agenda III

• 6.3.5 Evaluate the harmonisation and consistency
  of regulatory approach between EU member states.
  Identify scientific issues acting as a barrier to
  implementation of such harmonisation and define
  research designed to resolve the issues.
•  
• 6.3.6 Identify and evaluate the quality of data
  required by the regulatory process to approve a
  veterinary medicine. Define the most appropriate
  level to satisfy the needs of the system.

10
Research Agenda III

• 6.3.5 Evaluate the harmonisation and consistency
  of regulatory approach between EU member states.
  Identify scientific issues acting as a barrier to
  implementation of such harmonisation and define
  research designed to resolve the issues.
•  
• 6.3.6 Identify and evaluate the quality of data
  required by the regulatory process to approve a
  veterinary medicine. Define the most appropriate
  level to satisfy the needs of the system.

11
Research Agend IV

•  
• 6.3.7 Evaluate the relevance and importance of
  the environmental assessment process and define
  the quality of data required for veterinary
  medicines of differing types. To what level of
  detail should environmental risk assessment be
  established to be effective and what further
  research would assist in improving the
  importance, relevance and value of environmental
  assessments for veterinary medicines.

12
Diagnostic tests I

• 6.4.1 Support projects for the establishment of
  international sample panels / or standard sera,
  that can be used in test validations. They should
  be available for all diagnostics producers.
•  
• 6.4.2 Encourage and finance joint projects
  between institutes and the industry

13
Diagnostic tests I

• 6.4.1 Support projects for the establishment of
  international sample panels / or standard sera,
  that can be used in test validations. They should
  be available for all diagnostics producers.
•  
• 6.4.2 Encourage and finance joint projects
  between institutes and the industry

14
Diagnostic tests II

• 6.4.3 Establish links and promote the information
  flow between institutes, vaccine and diagnostics
  producers especially for the marker vaccine
  development area.
• 6.4.4 Support projects shared with Central and
  Reference laboratories for the validation of
  diagnostic products in different geographical
  locations to facilitate the Fit for purpose
  recognition.

15
Diagnostic tests II

• 6.4.3 Establish links and promote the information
  flow between institutes, vaccine and diagnostics
  producers especially for the marker vaccine
  development area.
• 6.4.4 Support projects shared with Central and
  Reference laboratories for the validation of
  diagnostic products in different geographical
  locations to facilitate the Fit for purpose
  recognition.

16
Diagnostic tests III

• 6.4.5 Develop and introduce quality standards
  regarding diagnostic producers, concerning the
  implementation of an industrial standard that
  sets the conditions of the production of quality
  veterinary diagnostics.

17
Societal Acceptance of technology

• Priority areas for Research.
• 6.4.1 Establish a research programme into
  consumer perception and expectations of the new
  technologies and the consequent acceptance of new
  veterinary medicines
• 6.4.2 Review existing research findings on
  social perceptions of the new technologies and
  new veterinary medicines
• 6.4.3 Study factors which influence consumer
  behaviour in relation to food safety
• 6.4.4. Develop a risk communication strategy to
  educate the public on GM vaccines and
  pharmaceuticals and identify the most effective
  ways to communicate the information.

18
Societal Acceptance of technology

• Priority areas for Research.
• 6.4.1 Establish a research programme into
  consumer perception and expectations of the new
  technologies and the consequent acceptance of new
  veterinary medicines
• 6.4.2 Review existing research findings on
  social perceptions of the new technologies and
  new veterinary medicines
• 6.4.3 Study factors which influence consumer
  behaviour in relation to food safety
• 6.4.4. Develop a risk communication strategy to
  educate the public on GM vaccines and
  pharmaceuticals and identify the most effective
  ways to communicate the information.

19
Societal Acceptance of technology

• Priority areas for Research.
• 6.4.1 Establish a research programme into
  consumer perception and expectations of the new
  technologies and the consequent acceptance of new
  veterinary medicines
• 6.4.2 Review existing research findings on
  social perceptions of the new technologies and
  new veterinary medicines
• 6.4.3 Study factors which influence consumer
  behaviour in relation to food safety
• 6.4.4. Develop a risk communication strategy to
  educate the public on GM vaccines and
  pharmaceuticals and identify the most effective
  ways to communicate the information.

20
Societal Acceptance of technology

• Priority areas for Research.
• 6.4.1 Establish a research programme into
  consumer perception and expectations of the new
  technologies and the consequent acceptance of new
  veterinary medicines
• 6.4.2 Review existing research findings on
  social perceptions of the new technologies and
  new veterinary medicines
• 6.4.3 Study factors which influence consumer
  behaviour in relation to food safety
• 6.4.4. Develop a risk communication strategy to
  educate the public on GM vaccines and
  pharmaceuticals and identify the most effective
  ways to communicate the information.

21
Societal Acceptance of technology

• Priority areas for Research.
• 6.4.1 Establish a research programme into
  consumer perception and expectations of the new
  technologies and the consequent acceptance of new
  veterinary medicines
• 6.4.2 Review existing research findings on
  social perceptions of the new technologies and
  new veterinary medicines
• 6.4.3 Study factors which influence consumer
  behaviour in relation to food safety
• 6.4.4. Develop a risk communication strategy to
  educate the public on GM vaccines and
  pharmaceuticals and identify the most effective
  ways to communicate the information.

22
Community Animal Health Policy (CAHP)

• 6.6.1 Maintain contact with the CAHP Evaluation
  Team in order to contribute to their review of
  the research requirements for the CAHP.
•  
• 6.6.2 Ensure that the work of the Platform
  contributes and supports the CAHP through the
  strategic research agenda.

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Thank you for your time

• Steve Dean