Scientific advice and protocol assistance: Regulatory and procedural guidance

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This page lists the guidance for companies seeking scientific advice or protocol assistance.

Table of contents


Guidance for companies

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Document(s) Language Status First published Last updated Effective Date
Dates of 2018 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (English only)   2017-07-24    
Dates of 2017 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (English only)   2013-06-24 2017-07-04  
CHMP protocol assistance scientific advice briefing document template (English only)   2010-06-18 2016-02-12  
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (English only)   2009-01-22 2017-09-18  
Template letter of intent for request of qualification of novel methodologies to the Scientific Advice Working Party (English only)   2009-09-18 2015-06-26  
Template letter of intent for request of scientific advice or protocol assistance (English only)   2009-11-03 2017-01-25  
Template letter of intent for parallel consultation EMA / EUnetHTA (English only)   2014-01-23 2017-07-04  
General principles: European Medicines Agency-Food and Drug Administration parallel scientific advice (English only)   2009-07-22 2017-05-19  
New framework for scientific advice & protocol assistance (English only) adopted 2006-04-26    
Overview of responses received from interested parties and EMEA recommendations on the new framework for scientific advice & protocol assistance (English only)   2006-04-25    

Standard operating procedures and work instructions

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Document(s) Language Status First published Last updated Effective Date
Standard operating procedure for scientific advice and protocol assistance procedure (English only) adopted 2008-07-01 2015-12-03 2015-12-01
Work instructions for general dealings between SAWP secretariat and working parties, SAGs, committees and patients' organisations (English only) adopted 2009-11-24   2009-11-26
Work instructions for organisation of Scientific Advice Working Party meetings (medicines for human use) (English only) adopted 2008-07-28 2013-06-11 2013-06-11
Work instructions for organisation of scientific-advice and protocol-assistance presubmission meetings (English only) adopted 2008-07-01 2013-06-24 2013-06-24
Work instructions for organisation of discussion meetings for scientific advice and protocol assistance (English only) adopted 2008-07-03 2012-05-15 2012-05-16
Work instructions for validation of scientific advice and protocol assistance requests (English only) adopted 2008-10-03   2008-10-03
Work instructions for scientific-advice / protocol-assistance peer review (English only) adopted 2009-03-05 2013-05-03 2013-05-06
Work instructions for nomination of co-ordinators for scientific advice and protocol assistance (English only) adopted 2008-07-01 2012-05-08 2012-05-07
Work instructions for finalisation of scientific-advice and protocol-assistance letters (English only) adopted 2008-10-24 2013-01-10 2013-01-10
Work instructions for use of scientific-advice and protocol-assistance database (English only) adopted 2008-10-06 2013-06-24 2013-06-24