1. Developments in the EU medicines regulatory network
David Murphy
Veterinary Information Day 2018
13th June, Hilton Hotel Dublin Airport

2. Theme 2: Contributing to animal health and human health in relation to veterinary medicines
10/04/2019

3. CVMP priority areas of activity 2018
ITF, ADVENT (Q+As for stem cells and mAbs), scientific advice
MUMS classification/guidelines
Supporting product development
Field efficacy studies for vaccines
VAMF
Measures to promote availability of vaccines in emergency situations
Availability (vaccines)
Continue work on GL on risk assessment of AMs
AMEG on antimicrobial categorisation
Finalise ‘pilot’ on SPC harmonisation of ‘established’ antimicrobials
Antimicrobial resistance
10/04/2019

4. Other activity (some recently adopted CVMP documents)
GL on user safety of topically administered veterinary medicinal products
GL on assessing the environmental and human health risks of VMPs in groundwater
GL on the chemistry of active substances for VMPs
GL on a phased implementation of requirements to control elemental impurities in VMPs
Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs
Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action
Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance status of chemical substances in MAAs for VMPs
Reflection paper on promotion of pharmacovigilance reporting
10/04/2019

5. Consumer safety – diethanolamine, MRLs for biologicals
Other activity…….
Consumer safety – diethanolamine, MRLs for biologicals
Environment – PBTs, VMPs in aquaculture, AMR
Pharmacovigilance – post-marketing surveillance based on signal detection, develop strategy on safety communication
Quality – histamine in gentamicin-containing VMPs for horses
Training – reinforce scientific and regulatory capacity
10/04/2019

6. Challenges for the Network
10/04/2019

7. Loss of UK contribution to the Network
Loss of UK capacity and expertise has the potential to stress the network
Responsible for ~20% of CAPs, ~30% MRP/DCP
Significant contributor to assessment activity as non-lead MS
Significant contributor at all CVMP WPs, CMDv
10/04/2019

8. 10/04/2019

9. Relocation – impact
Not expected to negatively impact on the holding of CVMP meetings or assessment procedures
Not expected to negatively impact on the holding of CMDv meetings
May impact on physical meetings of CVMP working groups
Reduction in secretariat support for WP activities
potential to impact on CVMP priority areas of activity

10. The new veterinary regulation
Objectives:
increase the availability of veterinary medicinal products;
reduce administrative burdens;
stimulate competitiveness and innovation;
improve the functioning of the internal market; and
address the public health risk of antimicrobial resistance (AMR)
- Without compromising protection of public and animal health
10/04/2019

11. Impact on scientific committees of EMA
Explicit requirements
Provide scientific advice on request to the European Commission as part of consultation in drawing up delegated and implementing acts specified in the regulation
Implicit requirements (examples)
Endorse new and revised guidance which involve CVMP and its working parties (e.g. Good Pharmacovigilance Practice, list of variations requiring assessment)
Provide scientific advice to the EC on other obligations in the new veterinary regulation (e.g. in relation to ERA, withdrawal periods under the cascade)
10/04/2019

12. Phases of delegated and implementing acts related to the NVR
12 months before
date of application
Entry into force
Date of application
It is assumed that the regulation will ‘be applied’ three years later (i.e. become operable)
2018
Aujourd'hui
366 jours
367 jours
366 jours
Within 5 years from the date of application
It is assumed that the regulation will enter into force (i.e. be adopted by Council and Parliament) by the end of 2018 or first quarter of 2019.
Note: Others with no timeline

13. Examples of likely future activity to support NVR
Dossier data requirements
Provide advice to the European Commission on request on revision of the technical annexes to the regulation to
Reflect the content of the revised regulation e.g.
Requirements for biological products
Requirements for MUMS and authorisations under exceptional circumstances
Reflect scientific progress since last revision
Incorporate changes to promote availability
10/04/2019

14. Examples of likely future activity to support NVR
Antimicrobials
To define criteria for restricting antimicrobial substances to use in man (i.e. not for use in animals) and to propose lists of antimicrobials not to be used in animals
To propose lists of antimicrobials the use of which should be restricted under the prescribing ‘cascade’ (i.e. off label use)
To advise on scientific aspects related to collection of data by Member States on use of antimicrobials in different animal species
10/04/2019

15. Examples of likely future activity to support NVR
Pharmacovigilance
To provide advice on guidance on Good Pharmacovigilance for VMPs taking into account the changes introduced (e.g. phase out of routine PSURs and move to system based on signal management, new obligations on MAH)
ERA
Acceptable use of PBT substances as VMPs
Advice on feasibility of monograph system for ERA of active substances
10/04/2019

16. Brexit will challenge the Network
Summary
Brexit will challenge the Network
capacity and expertise
relocation
HMA and EMA are working to minimise disruption
Redistribution of UK product portfolio
Capacity building
Developing available expertise
EMA business continuity plan
10/04/2019

17. Summary
New Veterinary Regulation will introduce substantial changes to the system of authorisation of VMPs
For the Network, the anticipated workload is high and the timescale for implementation is ambitious
The work programmes of the CVMP and its working parties will be amended to take into account the new tasks arising
Given the proposed ‘phased’ application of delegated and implementing actions, there will be a period of change up to and after the date the NVR becomes operable.
10/04/2019

18. Thank you vetinfo@hpra.ie