Provision and exchange of information - WHO · CTD Table of Contents CTD Introduction Module 1...
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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