Transcript VICH Task Force for Efficacy Studies for Combination Products

VICH Task Force for General
Combination GL Products
Progress Report for the 33th SC /7th VOF meeting
TF members
VICH
members
Observer
VOF
members
NVAL, JMAFF (chair)
JVPA
IFAH-EU
EU
US FDA
AHI
South Africa, Nat’l Dept. health
China PR, IVDC
Argentina, SENASA
Taiwan, Council of Agriculture
UEMOA
CAMEVET
K. Noda
E. Oishi
M. Bobey
K. Healey
C. Groesbeck
B. McKusick
V. Naidoo
S. Xu
L. Sbordi
T-R. Jan
K.Th. Domagni
L. Sbordi
Introduction (Brief History)
Nov. 2013
29th VICH / 3rdVOF
• Draft Concept Paper “Efficacy studies for
combination drug products” from China PR
• TF to elaborate a discussion paper (DP) with
a more focused scope
Jun. 2014
30th VICH / 4thVOF
• Global catalogue of main groups/classes of
approved combination products
Feb. 2015
31th VICH / 5thVOF
• Catalogue of relevant guidance/guidelines
for combination products already in place
Oct. 2015
32th VICH/ 6thVOF/
VICH5
• DP “Major veterinary combination products
in the world and relative guidance/guideline
in place”
• Decided the first topic to be a “General GL”.
• Mandated the TF to develop a CP to clarify
timeline and scope.
Jun. 2016
33rd SC / 7th VOF
• Presents a draft CP at the SC/VOF meetings
Major Combination-products
40
AP:
Voting from TF members
35
30
25
20
Antiparasitics
Vit:
Vitamin
AM: Antimicrobials
Min:
Mineral
AI:
Anti-inflammatories
Gastr:
Gastrointestinal
AS:
Antiseptics
Horm:
Hormone
DI:
Disinfectants
Cardiol:
Cardiology
X:
others
15
10
5
0
APs
AMs
AM+X
AI
AS
AS+DI
DI
Combination
Vit
Vit+Min Gastr
Horm Cardiol
X
Priority Setting
 Regulators do not wish to encourage new developments of AM
combination.
 GL on such combination could be misunderstood as encouragement.
 Antiparasitic combination should be addressed by the
Anthelmintics EWG in the future.
The first topic : General combination GL
General GLs already in place
EMEA/CVMP/83804/05
Introductory
part
 Introduction (background)
 Scope
 Legal Basis
Discussion
part
 Justification of the Combination
 Interactions
 Indications
 Potential Advantages
• Improvement of activity
• Broadening of the activity spectrum
• Use of a combination product versus
combined use of single substances
 Risk-Benefit assessment
Dossiers
Requirements
part
 General requirements
 New fixed combination products
 Combination products that meet the
criteria for well established use
 Combination products that meet the
criteria for generic application
 Specific Requirements
 Safety and residues documentation
 Preclinical and clinical documentation
(Preclinical data, Dose-finding, Tolerance,
Clinical data, Resistance, Exceptions)
FDA/ CVM GFI #24
 Introductory statement






Non-Interference
Rational
Titration
Ranges
General Efficacy
Combination Claims and
Treatment Comparisons
a) If claims are different for each
drug ingredient…then
(A+B)> B for claim Y
(A+B)> A for claim X.
b) If the claim is the same for
each ingredient…then
(A+B)> for claim X
(A+B)> for claim X.
:
:
:
:
Problem Statement
 No globally applicable guidance
 How to best investigate drug-to-drug interactions
 Synergy/Potentiation/Additive
 Interference
 How to comprehensively assess
 Efficacy
 Safety (residue depletion)
 How to avoid development of resistance
Anticipated benefit to:
 Industry (applicant)
 Help applicants to appropriately represent the
benefit of combination products
 Regulatory Authorities (reviewer)
 Provide a harmonized framework for assessment
 Reduce the time for reviewing technical dossiers
 Reach the benefit/risk conclusion faster
Recommendation
 General combination GL
 EU and US GL are the representative General GLs.
 Internationally harmonized GL by extracting
appropriate elements from them.
 Specific combination GL
 Anti-Parasitics  Anthelmintics-EWG.
 Other specific combination in the future.
 After some experiences
 Further discussion needed
Milestones
June 2016
33rd SC / 7th VOF
Feb. 2017
34th SC / 8th VOF
Nov. 2017
35th SC / 9th VOF
June 2018 –
36th SC / 9th VOF –
• Briefly review the draft CP
• Initiate internal review in each organization
• Finalize the CP and discuss feasibility
• Additional survey and/or analysis (if needed)
• Decide to establish an EWG
• Nominate Chair and Topic leader.
• EWG would present the first draft