Download Implementation of VICH guidelines

Principles for the assessment and
authorisation of antimicrobials in
the EU
VICH Outreach Forum, October 2015
Presented by Dr Anja Holm
An agency of the European Union
Chair of the EMA Committee For Medicinal Products for Veterinary Use (CVMP)
Data requirements
• Quality, safety and efficacy
• For veterinary medicines for food-producing animals :
• establishment of maximum residue levels (MRLs); includes
data for establishment of a microbiological ADI according to
VICH GL36
• Data according to VICH GL 27 for new products, no specific
GL for assessment of data
• MIC and PK/PD data for use in efficacy assessment
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Assessment and authorisation of antimicrobials
Efficacy assessment and indications (1/3)
• Key considerations in the authorisation of antimicrobials:
• Establish for which microorganisms and strains will the product be
efficacious
• Determine the appropriate dosage regimen (mg/kg and duration)
• For this, data to establish the MIC and data on the
pharmacokinetics and pharmacodynamics (PK/PD studies) of
the antimicrobial substance are required
• CVMP GL for the demonstration of efficacy for veterinary
medicinal products containing antimicrobial substances
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Assessment and authorisation of antimicrobials
Efficacy assessment and indications (2/3)
• When approving a veterinary medicine containing an
antimicrobial particular consideration is given to the
effectiveness of the drug by addressing the following:
• The proposed indication/claim: disease and bacteria;
• The intended aim of the product (treatment versus
prevention versus growth promotion*); and
• The appropriateness of the advice for use and dosage
regimen.
• Communication to veterinary surgeon and user
*g.p.-claim is not allowed in EU
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Assessment and authorisation of antimicrobials
Efficacy assessment and indications (3/3)
• The indication/claim for the approved medicine should identify
the bacteria against which the drug is effective.
• These bacteria should be listed in the approved product
literature for each target animal species and indication for use.
• The product literature should contain the advice that,
whenever possible, laboratory diagnosis and susceptibility
testing should be carried out by the veterinary surgeon before
prescribing the antimicrobial.
• Criteria for the decision on whether it is appropriate to use the
medicine and how it should be used can also be included.
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Assessment and authorisation of antimicrobials
Principles of prudent use (1/2)
• The conditions of use contained in the marketing authorisation
take into account the principles of prudent / responsible use.
• These principles need to be clearly communicated to
veterinary surgeon and user: product literature.
• Particular importance: dosage regimen determined based on
the efficacy and safety data for the product.
• Standard prudent use phrases to be used in SPC and product
information.
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Assessment and authorisation of antimicrobials
Principles of prudent use (2/2)
• Examples for standard prudent use phrases:
• ‘The <name of antimicrobial> should be used for treatment of
severe infections only.’
• ‘The <name of antimicrobial> should be reserved for the
treatment of clinical conditions which have responded poorly,
or are expected to respond poorly, to other classes.’
• for the Critically Important Antimicrobials (WHO/OIE-list), e.g.
fluoroquinolones, cephalosporins, macrolides.
• Use of antimicrobials in food-producing animals:
only on veterinary prescription.
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Assessment and authorisation of antimicrobials
For more details:
•
K. Grein, Responsibilities of regulatory agencies in the marketing of
antimicrobials, Rev. sci. tech. Off. int. Epiz., 2012, 31 (1): 289-298:
http://web.oie.int/boutique/extrait/22grein289298.pdf
•
CVMP guideline on the SPCs for antimicrobial products:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin
e/2010/02/WC500070670.pdf
•
CVMP guideline for the demonstration of efficacy for veterinary medicinal
products containing antimicrobial substances:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen
eral_content_000381.jsp&mid=WC0b01ac058002ddc2#Antimicrobials
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Assessment and authorisation of antimicrobials
Thank you for your attention
Any questions
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Assessment and authorisation of antimicrobials