EU US MUTUAL RECOGNI TI ON AGREEMENT First annual EMA-EuropaBio - PowerPoint PPT Presentation

EU US MUTUAL RECOGNI TI ON AGREEMENT First annual EMA-EuropaBio bilateral meeting 9 th June 2017 Presented by Brendan Cuddy Head of Manufacturing and Quality Compliance European Medicines Agency An agency of the European Union

US EU MRA

Scope Post- approval inspections Pre-approval inspections ( * ) I nspect. outside the territory

Products coverage - Hum an blood - Marketed FP for Hum an use - Hum an plasm a Anim al use - Hum an tissues - I nterm ediates - Organs - Certain biological - Veterinary im m unologicals products - ATMP’s - Active pharm aceutical ingredients

Products coverage Marketed finished Marketed biological products for pharm aceuticals for hum an use: hum an use: - Medical gases - Therapeutic biotechnology - - Radiopharm aceuticals / derived biological products radioactive biological - Allergenic products products - Herbal products ( * ) I nterm ediates. - Hom eopathic products Active pharm aceutical ingredients I MPs ( * * ) Veterinary products: Vaccines for hum an use - Veterinary Pharm aceuticals - Pre-m ixes for the preparation Plasm a derived pharm aceuticals of vet m edicated feeds 1 5 th July 2 0 1 9 1 5 th July 2 0 2 2

Process Assessm ent of each Party: - EU assessm ent of FDA: 1 st July 2 0 1 7 - FDA assessm ent of EU I nspectorates: 1 5 th July 2 0 1 9 ( * ) JOI NT AUDI T PROGRAMME: HMA voluntary program m e. - - Objective: to achieve, m aintain and verify equivalence and practical application of GMP standards by national inspectorates Agencies across the EEA. - Tool for international collaboration: to preserve confidence in the equivalence of EEA GMP system s to all MS and to EU MRA partners. - National inspectorates are audited by qualified auditors ( evaluation checklist and observed inspections) . - FDA observed / w ill observe the EU JAP audits ( 2 0 1 4 -2 0 1 7 ) CAPABI LI TY ASSESSMENT PACKAGE

Tim elines and m ilestones Transition phase 1 st July 2017: EU assessment of FDA (human) Signature 1 st Novem ber 2 0 1 7 1 5 th July 2 0 1 9 Entry into force - - All EU MS recognized - 8 MSs recognized - Batch testing - Decision on Vets 1 5 th July 2 0 2 2 - Broaden scope ( products)

I nspections I nspections / GMP docum ents Manufacturing facilities located in Manufacturing the territory of the facilities located issuing Authority Products not outside the territory (products included covered. of the issuing in the scope). Products to be Authority. covered: to notify in advance. Possibility of joint inspection.

Request of inspections Docum ents already • Reason for the request available/ pending • I ssues to be addressed in the inspection I nspection by the • Tim eline requested Authority ( w here the site is located) I nspection by the Requesting Authority ( joint inspection)

Safeguard clause To ensure the protection of Exceptional cases hum an/ anim al health I nspection in the territory of the other party Notification in Right to join the w riting inspection

Ongoing topics I m pact on Exchange of variations inform ation Official GMP docum ents Roadm ap for veterinary products

Any Questions? Brendan.cuddy@ema.europa.eu European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone + 44 (0)20 3660 6000 Facsim ile + 44 (0)20 3660 5555 Send a question via our w ebsite www.ema.europa.eu/ contact Follow us on @EMA_ New s