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