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

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

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

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

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

Challenges for the Network 10/04/2019

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

10/04/2019

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

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

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

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

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

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

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

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

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

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