European Global Technology Platform for Global Animal Health

1
European Global Technology Platform for Global
Animal Health

• Strategic Research Agenda
• Chapter 6

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 develop a veterinary
  specific regulatory environment.
• 6.3.2 Research into the value, use, impact and
  lessons learned from the practical experience of
  guidelines that have been issued to the industry
  in order to develop and improve the use of
  guidelines where appropriate.
•  6.3.3 Develop an effective risk-based model to
  define the risks and benefits from veterinary
  medicines, to use the model to make risk-benefit
  based decisions and determine the testing
  required for new products to underpin this
  approach.

6
Research Agenda II

• 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...
•  6.3.5 Evaluate the impact of new legislation on
  improved harmonisation between EU member states.
• 6.3.6 Identify and evaluate the product quality
  data required by in the regulatory process to
  approve a veterinary medicine. What is the most
  appropriate quality to satisfy the needs of the
  system?
•  6.3.7 Evaluate the relevance and importance of
  the environmental assessment and define the level
  required for veterinary medicines of differing
  types. How far is environmental risk a real issue
  and could research investigate the importance,
  relevance and value of environmental assessments
  for all veterinary medicines?

7
Recommendation 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 develop a veterinary specific regulatory
  environment.
• 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 enable
  a veterinary specific regulatory environment.
• (Note Examples could be Food safety animal
  welfare inform risk benefit evaluation)

8
Recommendations 6.3.2

• Research into the value, use, impact and lessons
  learned from the practical experience of
  guidelines that have been issued to the industry
  in order to develop and improve the use of
  guidelines where appropriate.
• Research into the value, use, impact and lessons
  learned from the practical experience of
  regulatory guidelines and monographs in order to
  ensure that guidelines and monographs remain
  appropriate to developing scientific knowledge.
• Examples? PK/PD as measure of bioequivalence

9
Recommendation 6.3.3

• Develop an effective risk-based model to define
  the risks and benefits from veterinary medicines,
  to use the model to make risk-benefit based
  decisions and determine the testing required for
  new products to underpin this approach.
• Develop an effective risk-based model to define
  the risks and benefits in the use of veterinary
  medicines with the intent to use the model in
  making risk-benefit based decisions and to
  determine the testing required for new products
  to underpin this approach.

10
Recommendation 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...
• No change

11
Recommendation 6.3.5

• Evaluate the impact of new legislation on
  improved harmonisation between EU member states.
• Evaluate the harmonisation of regulatory approach
  between EU member states. Identify scientific
  issues acting as a barrier to harmonisation and
  define research designed to resolve the issues.

12
Recommendation 6.3.6

• Identify and evaluate the product quality data
  required by in the regulatory process to approve
  a veterinary medicine. What is the most
  appropriate quality to satisfy the needs of the
  system?
• 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?

13
Recommendation 6.3.7

• Evaluate the relevance and importance of the
  environmental assessment and define the level
  required for veterinary medicines of differing
  types. How far is environmental risk a real issue
  and could research investigate the importance,
  relevance and value of environmental assessments
  for all veterinary medicines?
• Evaluate the relevance and importance of an
  environmental assessment process and define the
  quality of data required for veterinary medicines
  of differing types. To what level should
  environmental risk be established to be effective
  and what further research would assist in
  establishing the importance, relevance and value
  of environmental assessments for veterinary
  medicines?

14
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.

15
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.

16
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.

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
Thank you for your comments