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

An agency of the European Union

EU US MUTUAL RECOGNI TI ON AGREEMENT

First annual EMA-EuropaBio bilateral meeting 9th June 2017

Presented by Brendan Cuddy Head of Manufacturing and Quality Compliance European Medicines Agency

US EU MRA

Scope

Post- approval inspections Pre-approval inspections ( * ) I nspect.

• utside

the territory

• Hum an blood
• Hum an plasm a
• Hum an tissues
• Organs
• Veterinary

im m unologicals

• ATMP’s

Products coverage

• Marketed FP for

Hum an use Anim al use

• I nterm ediates
• Certain biological

products

• Active pharm aceutical

ingredients

Products coverage

Marketed finished pharm aceuticals for hum an use:

• Medical gases
• Radiopharm aceuticals /

radioactive biological products

• Herbal products ( * )
• Hom eopathic products

Marketed biological products for hum an use:

• Therapeutic biotechnology -

derived biological products

• Allergenic products

I nterm ediates. Active pharm aceutical ingredients I MPs ( * * ) Veterinary products:

• Veterinary Pharm aceuticals
• Pre-m ixes for the preparation
• f vet m edicated feeds

1 5 th July 2 0 1 9

Vaccines for hum an use Plasm a derived pharm aceuticals

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
• f 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

Signature

1st July 2017: EU assessment

• f FDA (human)

1 st Novem ber 2 0 1 7

• Entry into force
• 8 MSs recognized

1 5 th July 2 0 1 9

• All EU MS recognized
• Batch testing
• Decision on Vets

1 5 th July 2 0 2 2

• Broaden scope ( products)

Transition phase

I nspections

I nspections / GMP docum ents

Manufacturing facilities located in the territory of the issuing Authority (products included in the scope). Manufacturing facilities located

• utside the territory
• f the issuing

Authority. Products not covered. Products to be covered: to notify in

• advance. Possibility
• f joint inspection.

Request of inspections

• Reason for the request
• I ssues to be addressed

in the inspection

• Tim eline

Docum ents already available/ pending I nspection by the requested Authority ( w here the site is located) I nspection by the Requesting Authority ( joint inspection)

Safeguard clause

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

• ther party

Ongoing topics

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

Any Questions?

Follow us on @EMA_ New s

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