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Provision and exchange of information

Provision of information about “registered” medicines:European Public Assessment Reports: EPARs

Nathalie Seigneuret, Paediatric sectionEuropean Medicines Agency

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WHAT DOES THE EMEA PUBLISH ON MEDICINAL PRODUCTS?

The EMEA publishes:

•Press release•Questions/Answers ± Product Information•Assessment reportfor granting of Marketing Authorisation, refusal, withdrawal of an application, and post-authorisation activities.

The principles for deletion of commercially confidential information will be applied.

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What are the provisions for publication?

• In European Legislation: Regulation (EC) 726/2004

Article 13(3)– EPAR Summary

Article 12(3) – Refusals

Article 11 – Withdrawals

• EMEA Management Board transparency measure (September 2006)

– Withdrawals between CxMP opinion and EC decision

– Withdrawals of application for new indication– Refusal of application for new indication

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What is the evaluation process?

Pre-sub-mission Primary Evaluation Clock

Stop

Day 1 Day 120 day 120 Day 180 Day 181 Day 210 Answers

Scientific Advice

Rap/Co-Rap

Secondary Evaluation

Clock Stop*

Decision M

akingProcess

Validation

Day 120 List of

questions

AR = assessment report; JAR = Joint Assessment report *optional; CHMP = Committee for Medicinal Products for Human Use

Day 80

ARs

Day 150 JAR

Day 180 List of

outstanding issues CHMP

AR

Day 181 JAR

EPAR

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• Concise document providing the scientific rationale on which the CHMP has based its opinion (based on the different reports)

• Substantiation of the statements made in the different sections in the Summary of Product Characteristics so that consistency between these two documents is reached

• Overview of the CHMP discussion

• Trail for key issues identified during the review / authorisation (e.g. major objections)

What is a CHMP AR?

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QualityOverall

Summary

Non clinicalOverview

ClinicalOverview

Non clinicalSummaries

ClinicalSummary

Module 3

Quality

Module 4Non clinical

Study Reports

Module 5Clinical

Study Reports

Module 2

CTD Table of Contents

CTD Introduction

Module 1Regional

Information

Module 2-5CTD

Module 1:NOT part of the CTD Regional: EU, US, Japan

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Marketing Authorisation Application:

Common Technical Document (CTD)

Module 2

What is the starting point?

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What is the structure of CHMP AR?

• Introduction

• QualityMethods (M), Results (R), Discussion, Conclusions

• Non-ClinicalMR, Discussion, Conclusions

• Clinical EfficacyMR (CONSORT), Discussion, Conclusion

• Clinical SafetyMR (CONSORT), Discussion, Conclusion

• Overview and Benefit-Risk Assessment

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European Public Assessment Report (EPAR)

• Distinctive feature of the Centralised System -increased transparency/ openness to public

• Essentially, it is the CHMP assessment report (without annexes and commercially confidential information which is deleted after consulting with the Company)

• With a summary understandable by the general public

• With Authorised Presentations, Summary of Product Characteristics, Labelling and Package Leaflets

• Regularly updated

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EMA has defined some principles to be applied for the deletion of commercially confidential information for the disclosure of EMA documents EMEA/45422/2006

Confidential:

Intellectual property, “know-how” and trade secrets

• e.g. formulae, processesCommercial confidences

• e.g. development plans

(EMEA/45422/06)

What is commercially confidential information ?

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What could be confidential for the EPAR?

Information:

• comprehensive and completePharmaceutical development

• commercially confidential(Non-)clinical development

• not commercially confidentialCommittee’s discussion

• not commercially confidential

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EPAR MODULAR APPROACH Who is the audience?

= available in all EU languages

Summary/ Presentations

Package Leaflet

Summary ofProduct Characteristics

Scientific discussion

Steps taken before authorisation of the product

Steps taken after granting the Marketing Authorisation (if applicable)

= available in English

Labelling

all readers

patients

pharmacists/patients

health professionals

scientific community /health professionals

anyone interested

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What is the structure of the EPAR?

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EPAR summaries

Legal basisEPAR shall include a summary written in a manner that is understandable to the general public. The summary shall contain in particular a section relating to the conditions of use of the medicinal product.

EC 726/2004, article 13(3)

Public-friendly language

‘Question and answer’ format (e.g What is <X>? What is <X> used for?)

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http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/landing/epar_search.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125

LINK TO EPAR WEBPAGE:

The Agency website

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Refusal EPAR (REPAR)

•Q&A on the refusal

•CHMP AR without commercially confidential information

•No Product information

•Static document

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Withdrawal EPAR (WEPAR)

•Q&A on the withdrawal

•CHMP AR without commercially confidential information

•No PI

•Static document