Scientific advice and protocol assistance: Regulatory and procedural guidance
This page lists the guidance for companies seeking scientific advice or protocol assistance.
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Dates of 2020 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (PDF/253.73 KB)
First published: 24/08/2018
Last updated: 08/07/2020
EMA/444946/2017 Rev. 2 -
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Dates of 2019 Scientific Advice Working Party (SAWP) meetings and submission deadlines for scientific advice, protocol assistance, qualification of biomarkers and parallel consultation EMA/EUnetHTA requests (PDF/233.31 KB)
First published: 01/10/2019
EMA/444927/2017 -
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CHMP protocol assistance scientific advice briefing document template (DOC/92.5 KB)
First published: 18/06/2010
Last updated: 12/02/2016
Rev. 1 -
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European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (PDF/368.01 KB)
First published: 22/01/2009
Last updated: 18/09/2017
EMA/691788/2010(EMEA-H-4260-01) Rev.9 -
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Template letter of intent for request of qualification of novel methodologies to the Scientific Advice Working Party (DOC/191.5 KB)
First published: 18/09/2009
Last updated: 18/03/2020 -
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Template letter of intent for request of scientific advice or protocol assistance (PDF/2.12 MB) (updated)
First published: 03/11/2009
Last updated: 11/08/2020 -
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General principles: European Medicines Agency-Food and Drug Administration parallel scientific advice (PDF/142.94 KB)
First published: 22/07/2009
Last updated: 19/05/2017
EMEA/24517/2009 -
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New framework for scientific advice & protocol assistance (PDF/80.4 KB)
Adopted
First published: 26/04/2006
Last updated: 26/04/2006
EMEA/267187/2005/ Rev. 1 -
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Overview of responses received from interested parties and EMEA recommendations on the new framework for scientific advice & protocol assistance (PDF/43.72 KB)
First published: 25/04/2006
Last updated: 25/04/2006
EMEA/31649/2006
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Standard operating procedure for scientific advice and protocol assistance procedure (PDF/206.88 KB)
Adopted
First published: 01/07/2008
Last updated: 03/12/2015
Legal effective date: 01/12/2015
SOP/H/3037 -
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Work instructions for general dealings between SAWP secretariat and working parties, SAGs, committees and patients' organisations (PDF/83.94 KB)
Adopted
First published: 24/11/2009
Last updated: 24/11/2009
Legal effective date: 26/11/2009
WIN/H/3036 -
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Work instructions for organisation of Scientific Advice Working Party meetings (medicines for human use) (PDF/125.89 KB)
Adopted
First published: 28/07/2008
Last updated: 11/06/2013
Legal effective date: 11/06/2013
WIN/H/3195 -
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Work instructions for organisation of scientific-advice and protocol-assistance presubmission meetings (PDF/88.55 KB)
Adopted
First published: 01/07/2008
Last updated: 24/06/2013
Legal effective date: 24/06/2013
WIN/H/3035 -
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Work instructions for organisation of discussion meetings for scientific advice and protocol assistance (PDF/145.18 KB)
Adopted
First published: 03/07/2008
Last updated: 15/05/2012
Legal effective date: 16/05/2012
WIN/H/3042 -
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Work instructions for validation of scientific advice and protocol assistance requests (PDF/139.24 KB)
Adopted
First published: 03/10/2008
Last updated: 03/10/2008
Legal effective date: 03/10/2008
WIN/H/3039 -
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Work instructions for scientific-advice / protocol-assistance peer review (PDF/83.07 KB)
Adopted
First published: 05/03/2009
Last updated: 03/05/2013
Legal effective date: 06/05/2013
WIN/H/3139 -
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Work instructions for nomination of co-ordinators for scientific advice and protocol assistance (PDF/136.82 KB)
Adopted
First published: 01/07/2008
Last updated: 08/05/2012
Legal effective date: 07/05/2012
WIN/H/3197 -
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Work instructions for finalisation of scientific-advice and protocol-assistance letters (PDF/151.51 KB)
Adopted
First published: 24/10/2008
Last updated: 10/01/2013
Legal effective date: 10/01/2013
WIN/H/3196 -
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Work instructions for use of scientific-advice and protocol-assistance database (PDF/193.81 KB)
Adopted
First published: 06/10/2008
Last updated: 24/06/2013
Legal effective date: 24/06/2013
WIN/H/3040