ema and collaborative registration processes impacting on ...ema and collaborative registration...
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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
EMAInternational@ema.europa.eu
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
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