Safeguarding public health
BIOABSORBABLE STENTS:
REGULATORY ISSUES
DR SUSANNE LUDGATE
Clinical Director
Medicines and Healthcare products Regulatory Agency, UK
Name MHRA
Date
2006
©
NO CONFLICT OF INTEREST
TO DECLARE
EU REGULATORY SYSTEM
investigation
action, including
recall, safeguard
Notified Body
compliance ERs
safety, performance
provide ifu
• quality systems
• design dossier
• clinical data
• ifu
• pmcf plan
• pms plan
accredit
audit
• clinical investigation
• humanitarian use
European market
Safeguarding Public Health
MHRA
Competent
Authority
• post market surveillance
• vigilance
Slide 3
2006
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CLINICAL INVESTIGATION
 clinical (previous experience, inclusion, exclusion, end points, duration)
 radiological (OCT, MSCT) / other investigations
 materials (tensile strength, radial force, balloon life, speed deflation)
 biological safety (animal studies)
 biocompatibility (thrombogenicity, complement, haemolysis)
 sterilisation validation
 shelf life, special storage conditions
 drug
- qualitative, quantitative details
- method of manufacture
- control tests
- stability
- local tolerance
- pharmacokinetics
- clinical data
Safeguarding Public Health
MHRA
Slide 4
2006
©
CLINICAL INVESTIGATIONS
 end points to demonstrate safety, performance, claims
 NOT randomised controlled
 numbers
 timescales
 investigating centres
Safeguarding Public Health
MHRA
Slide 5
2006
©
OTHER FACTORS
 training
 adverse event reporting
 CE marking when?
 humanitarian use
Safeguarding Public Health
MHRA
Slide 6
2006
©
HUMANITARIAN USE
 one –off
 named patient basis
 forms to complete (of course!)
 24 hour turn around
Safeguarding Public Health
MHRA
Slide 7
2006
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POST-MARKET
“ …an undertaking by the manufacturer
to institute and keep up-dated a POST
MARKET SURVEILLANCE SYSTEM…”
 post market clinical plan
 extension clinical trial
 cohort study
 sub-population studies
 registers
 adverse incident reporting including ifu
Safeguarding Public Health
MHRA
Slide 8
2006
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CLINICIAN INPUT
 is the protocol designed to deliver (short, long term)
 meeting/teleconference with MHRA, manufacturer
 ensure adequate training
 consider humanitarian use
 remember post CE marking protocols, collect data
 report all adverse events to MHRA
 consider carefully off-label use (data collection)
 discuss problems early with MHRA
“we’re from the government and are here to help!”
Safeguarding Public Health
MHRA
Slide 9
2006
©