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Área de Ensayos Clínicos
Regulation of clinical trials with medicinal products: Where are we now?
Mariantonia Serrano Castro
Department of Medicines for Human UseAgencia Española de Medicamentos y Productos Sanitarios
(AEMPS)
CMC Strategy Forum Europe 2011 Barcelona, 21st March 2011
Área de Ensayos Clínicos
Basic legislation on CT
Directive 2001/20/CE Parliament and Council, 4th April,
Law 29/2006, 26th July, on guarantees and rational use of medicinal products and M.D. (Law on medicinal products).
Royal Decree 223/2004, 6 February, clinical trials (CT) of medicinal products
Área de Ensayos Clínicos
CT Subject CT Subject ProtectionProtection
Guarantees of Guarantees of Quality in the Quality in the
ResultsResults
NCAs NCAs cooperation on cooperation on CT assessment CT assessment and inspectionand inspection
TransparencyTransparency
Risks for Risks for environmentenvironment
Legislation Legislation objectives and objectives and
scopescope
Área de Ensayos Clínicos
Common Common proceduresprocedures
for Ethics Committee and for Competent Authority CT for Ethics Committee and for Competent Authority CT assessmentassessment
Standard for required notifications and for CT Standard for required notifications and for CT documentationdocumentation
Legislation Legislation objectives and objectives and
scopescope
Área de Ensayos Clínicos
EudraLex Volume 10 – Clinical Trials http://ec.europa.eu/health/documents/eudralex/vol-10/index_en.htm
-1 P.&C. Directive + 2 Commission Directives- CT dossier for CA and for EC- Safety rules (SUSAR, DSUR)- Quality of IMP rules (including GMP)- Good Clinical Practice and inspections- Rules for publication of CT- Ethical issues for paediatric CT
Área de Ensayos Clínicoswww.aemps.es Clinical Investigation
Clinical Investigation with medicinal
productsClinical Trials
Área de Ensayos Clínicos
EudraCT No.ProtocolPlan GCP standardsIMP quality standardsInsurance Single opinion by ECAgreement sponsor‐site for every siteAEMPS authorisationMinistry MARM authorisation (If CT on GMO)
Significant amendments review by EC/AEMPS
CT monitoring (including safety monitoring)SAE/SUSAR reporting
Annual safety report (DSUR)
Public registration of CT
End of trial notification
Results report
Publication of results
Before………………… During............... After….
Área de Ensayos Clínicos
EU Clinical Trials RegisterAll paediatric CT and phase II to IV non paediatric
AEMPS CT Data base
National Clinical Trials register (art. 62 Law 29/2006)
TransparencyEU CT application form
EudraCT (EU database on CT on IMP)
Área de Ensayos Clínicoswww.aemps.es Clinical Investigation
Office for supporting
Independent Clinical
Investigation
Área de Ensayos Clínicos
636588
665 675 643707
0
100
200
300
400
500
600
700
800
2005 2006 2007 2008 2009 2010
SubdirecciSubdireccióón General de Medicamentos de Uso Humanon General de Medicamentos de Uso Humano
Clinical trials authorised in Clinical trials authorised in SpainSpain
Área de Ensayos Clínicos
39694334
50284618
41534491
0
5300
2005 2006 2007 2008 2009 2010
Number of CT applications according to year of loading in EudraCNumber of CT applications according to year of loading in EudraCTTSource: EudraCTSource: EudraCT
Clinical trial applications in Clinical trial applications in the EU the EU
Área de Ensayos ClínicosClinical Trials Facilitation GroupVHP (voluntary harmonization
procedure)
Simultaneous scientific assessment by the concerned Competent Authorities: CTFG-VHP
• For CT with 3 o more EU countries• Application to the CTFG: Unique CT dossier, single e-application to CTFG, coordinated assessment, single list of questions, 60 days max.• Quick official national application afterwards(authorisation <10 days since a valid application)
CTFG: http://www.hma.eu/77.html
Área de Ensayos Clínicos
Where are we Where are we going?going?
11 Legislative changes Legislative changes
22 Operative changes Operative changes
Área de Ensayos Clínicos
Where are we Where are we going?going?
11 Legislative changes Legislative changes
Área de Ensayos Clínicos
• Cooperation in assessing and following up applications for clinical trials
• Risk‐adapted approach to the procedural aspects of clinical trials
• Ensuring compliance with good clinical practice in clinical trials performed in third countries
http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf
2012 new Directive
Área de Ensayos Clínicosvolume 10 Eudralex update• Question & Answer (v8 March 2011)• Development Safety Update Report (DSUR) • Guidance on Investigational Medicinal
Products (IMPs) and 'non investigational medicinal products' (NIMPs), rev.1 (March 2011)
• CT-3 guidance on safety and SUSAR reporting (COM Public consultation on 2010)
http://ec.europa.eu/health/human-use/clinical-trials/developments/index_en.htm
Área de Ensayos Clínicos
Amendment of Amendment of RD 223/2004 on CT RD 223/2004 on CT
•• Amend precepts which are Amend precepts which are inconsistent with inconsistent with Commission Commission
CT1CT1 guidance (30th March guidance (30th March 2010) 2010)
•• Avoid too much detail in the Avoid too much detail in the text in order to make easier the text in order to make easier the adaptation to EU legislative adaptation to EU legislative
changes in futurechanges in future•• Simplification where possible Simplification where possible •• Update precepts on Ethics Update precepts on Ethics
CommitteesCommittees(Law 14/2007 on biomedical (Law 14/2007 on biomedical
research)research)
Área de Ensayos Clínicos
Where are we Where are we going?going?
22 Operative ChangesOperative Changes
Área de Ensayos Clínicos
EudraCT v8• Submission of CT applications
without electronic signature• Possibility of submission of any
CT application/notification (except SUSARs and DSUR)
• Same validation rules as EudraCT v8 (plus CEIC and sites)
• CTA form should be filled in EudraCT v8.
Portal ECM• Update of CT application form
• Identification of fields to be displayed in the EU CT register
• CT applications for paediatric CT in third countries (part of a PIP).
• Multilingual free text fields
• Update of validation rules
Área de Ensayos Clínicos
• New legislation• Simplification of procedures• Coordination• Risk based approach• Increase of efficiency• Transparency
Key issues for Key issues for the futurethe future
Área de Ensayos Clínicos
[email protected] on clinical trials on
medicinal products
[email protected]/comments on electronic CT
submissions through Portal ECM
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