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An agency of the European Union
EMA and collaborative registration processes impacting on non-EU countries- including Article 58 procedure
Joint WHO-UNICEF-UNFPA Meeting with pharmaceuticals and diagnostics manufacturers and suppliers 25 November 2015 - Copenhagen, Denmark
Presented by Emer Cooke on 25 November 2015
Head of International Affairs
EMA: Quick introduction and reflections
Sharing assessments: Opportunities to share reviews
Article 58 : opportunities to be involved
Training opportunities
A quick introduction to EMA
Delivering through our network
� More than 45 national competent authorities dealing with
human and veterinary medicines and access to a network
of about 4,000 European experts
� EU institutions: European Commission, European
Parliament, other EU agencies
� European Pharmacopoeia (Council of Europe)
� Medicines Control Laboratories Network
And what we do
50 years’ harmonisation in Europe
1965 – 2015 = 50 years’ harmonisation and
cooperation between Member States…
… and 20 years’ anniversary of
creation of European Medicines Agency
and the European medicines regulatory
network
Common rules and platforms based on transparency
and trust – supports worksharing and collaboration
(both within and outside the EU)
EU work-sharing: the building blocks
� Common legislation
� Common scientific and technical standards
� Based on common format – the CTD
� Harmonised scientific guidelines (ICH and EU)
� Complemented by common European approach to
manufacturing and inspection
o EU GMP guide – same as PIC/S
o Single format for manufacturing authorisations, GMP
certificates
EU work-sharing: the outputs
� European Public Assessment Reports
� Concept extended to non-centralised products in 2005
� Certificates of medicinal product (based on WHO
scheme)
� EudraGMDP – database of all Manufacturing and
Distribution authorisations for sites in the EU
plus
� GMP certificates for inspections performed by any EU
authority (public access)
Collaborative registration processes in
practice
� WHO collaborative registration: EMA launched first
pilot procedure in 2015 with 11 African countries
� IGDRP: pilot for sharing generics’ assessment reports
begun in 2015
� Sharing full EMA assessment reports always possible
with permission of company
� “Article 58” procedure
The EU ‘Article 58’ procedure
� Supporting regulatory science and capacity building in
non-EU countries
� Introduced as a tool to help to expand LMIC access to new
medicines and improve public health
� Involvement of NRA experts and observers from ‘target’
countries and WHO
� Cooperation with WHO
� Scientific opinion on use
outside the EU
� Same scientific standards
Review of Experience with ‘Article 58’…
Strategic review commissioned 2015 with support of BMGF:
� Experts from NRAs consider involvement is valuable in
helping their local review and in building capabilities
� Misconception about ‘double standard’ because no EU
market approval
� Different awareness levels with NRAs
� Few NRA experts involved, few procedures so far (8)
� Need for better communication/education and better
streamlining collaboration with WHO
Training opportunities
� Training is key part of the European system
� International partners regularly invited to workshops
and training opportunities
e.g. GMP, pharmacovigilance and
GCP inspectors, PK/PD, etc
� EU Network Training Centre
launched 2015 (access for non-EU
regulators planned for future)
� Nominated contact points needed
Conclusions and Future Trends
� EU regulatory system based on mutual cooperation
and efficiencies
� Transparency of outputs/evaluations provide basis
for reliance and resource savings
� Increasing trend to share outputs and involve non-EU
regulators (Article 58, IGDRP pilot, collaborative
registration pilot)
� Sharing experiences helps to meet challenges of
globalisation, both regionally and internationally
Thank you for your attention
Further information
Contact the EMA International Affairs team at
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact
Follow us on @EMA_News