Information Outcomes From Regulatory Processes: Regine Lehnert

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Information outcomes from

regulatory processes
Regine Lehnert

Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data
which are submitted to regulatory authorities, February 2009

Synopsis
Sharing information
Goals
Tools/Ways
- in Europe
among authorities
with the public
- in WHO Prequalification Programme
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Artemisinin combined medicines, Kampala, February 2009

Sharing information
Goals
Improving health protection
making regulatory processes more efficacious
avoiding duplication of work
Improving transparency

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Artemisinin combined medicines, Kampala, February 2009

Sharing information in Europe (I)


EMEA - scope
scientific resources
- of 40 competent authorities
- in 30 countries
- with over 4,000 European experts
Collaboration with WHO, ICH,
European Pharmacopoeia

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Artemisinin combined medicines, Kampala, February 2009

Sharing information in Europe (II)


EMEA - tasks
evaluation of applications for European
marketing authorisation for medicinal products
monitoring of safety through pharmacovigilance
network
stimulating pharmaceutical innovation and
research by scientific advice and protocol
assistance.

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Artemisinin combined medicines, Kampala, February 2009

Sharing information in Europe (III)


Networking Tools
Scientific discussions/exchanges in each procedure
Regular assessors meetings
Telematics
- EudraServices,
e.g. EudraLink
- EudraData Warehouse,
e.g. EudraCT, EudraGMP, EudraVigilance

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Artemisinin combined medicines, Kampala, February 2009

Assessment outcomes Europe (I)


EMEA publications on medicinal products
EMEA Press releases, e.g. on committee meeting
outcomes, on withdrawals of applications and on refusals
Public statements on general, mostly technical issues
CHMP-Summaries of opinions on positive
recommendations for medicinal products
European Public Assessment Reports (EPARs) on
approved products
Product safety announcements on pharmacovigilance
issues.

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Artemisinin combined medicines, Kampala, February 2009

Assessment outcomes Europe (II)


What is an EPAR?
Scientific conclusion reached by the CHMP
Summary on the grounds for opinion
Information for the public after deletion of confidential data

Who is in charge of the EPAR?


Drafted by EMEA (SOP in place)
Usually involvement of Rapporteur
Agreement of Marketing Authorisation Holder
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Artemisinin combined medicines, Kampala, February 2009

Assessment outcomes Europe (III)


EPAR Structure
Summary for the public
All authorised presentations
Scientific discussion
Procedural steps taken before authorisation
Steps taken after authorisation
Product Information

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Artemisinin combined medicines, Kampala, February 2009

Assessment outcomes Europe (IV)


Product Information
Annex I - Summary of product Characteristics
Annex IIA - Marketing Authorisation Holder
responsible for Batch Release
Annex IIB - Conditions of the Marketing Authorisation
Annex IIIA - Labelling
Annex IIIB - Package Leaflet

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Artemisinin combined medicines, Kampala, February 2009

Assessment outcomes Europe (V)


How to get the information?

http://www.emea.europa.eu

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Artemisinin combined medicines, Kampala, February 2009

How to get the information


http://www.emea.europa.eu

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Artemisinin combined medicines, Kampala, February 2009

How to find an EPAR

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Artemisinin combined medicines, Kampala, February 2009

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Artemisinin combined medicines, Kampala, February 2009

Atripla
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Artemisinin combined medicines, Kampala, February 2009

How to find an EPAR

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Assessment outcomes Europe (VI)


Public assessment reports by National
regulatory authorities - in English
legal obligation to make information on medicinal
products publicly available
Guidance and template:
http://www.hma.eu/uploads/media/BPG_PAR.pdf
Examples:
- United Kingdom: MHRA
- The Netherlands: CBG-MEB
- Norway: Statens legemiddelverk
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Assessment outcomes WHO (I)


WHOPAR-Guideline

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Assessment outcomes WHO (II)

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Artemisinin combined medicines, Kampala, February 2009

Assessment
Outcomes
WHO (III)

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Artemisinin combined medicines, Kampala, February 2009

Assessment outcomes WHO (IV)


Structure

Part 1: Abstract
Part 2: All accepted presentations
Part 3: English package leaflet
Part 4: English summary of product characteristics
Part 5: English labelling
Part 6: Scientific discussion
Part 7: Steps taken for prequalification

Part 8: Steps taken after prequalification


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Assessment outcomes WHO (V)


How to get the information?

http://www.who.int/pq

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Artemisinin combined medicines, Kampala, February 2009

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Artemisinin combined medicines, Kampala, February 2009

How to find an WHOPAR

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Artemisinin combined medicines, Kampala, February 2009

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