Transcript VICH Task Force for Efficacy Studies for Combination Products

JMAFF (chair)
K. Noda
JVPA
IFAH-EU
EU
US FDA
AHI
E. Oishi
M. Bobey
K. Healey
C. Groesbeck
B. McKusick
Observer
South Africa, Nat. Dept. health
V. Naidoo
VOF
members
China PR, IVDC
Argentina, SENASA
Taiwan, Council of Agriculture
UEMOA
CAMEVET
S. Xu
L. Sbordi
T-R. Jan
K.Th. Domagni
L. Sbordi
Australia, APVMA
P. Reeves
NZ, Min. Primary Industry
W. Hughes
VICH
members
Additional
contributors
VICH Task Force for Efficacy
Studies for Combination
Products
Progress Report (Final)
Introduction
 At the 3rd VOF meeting in Nov 2013, China PR presented a Concept
Paper for a VICH guideline on “efficacy studies for combination drug
products”.
 The SC & VOF members welcomed the proposal confirming that it is an
important topic where guidance is currently lacking.
 The scope of this topic is very broad and could lead to several GLs.
 It would be useful to identify the different combinations available in
order to reach agreement on which GLs should be developed.
The SC decided to create a task force (TF) chaired by JMAFF.
Mandate
 To elaborate a discussion paper
proposing a more focused scope
for the development of a VICH GL
for efficacy studies for combination
products.
 The TF will
 Prioritize the target products >Explore Major combination
 Explore the possibility of
a general policy document >Analyse GLs already in Place
Major Combination-products
40
35
30
25
20
15
10
5
0
Combination-category
Technical Requirement GLs in Place
Title
EU
Guidance on
pharmaceutical
fixed combination
products
Category
Scope
General
EU data requirements for efficacy, safety
and residues documentation for veterinary
medicinal products, containing 2 or more
active substances.
General
Information and data to demonstrate that
the combination of drugs provides a
benefit that cannot be obtained by the use
of each of the drugs individually
US
CVM GFI #24 Drug
Combinations for
Use in Animals
Aust.
WAAVP guideline:
(Adopted as
National GL in
Australia)
Anthelmintic
combination products
targeting nematode
infections of ruminants
and horses
•
•
Antiparasitics
•
A scientific basis for the approval
Anthelmintic products with two or more
constituents with similar spectra of
activity from different pharmacological
classes
For use in addition to the existing
requirements/GLs for single-API
products.
WAAVP: World Association for Advancement of Veterinary Parasitology
Conclusion
 General combination GL
 EU and US are the representative General GLs.
 Internationally harmonized GL by extracting appropriate
elements from them.
 Specific combination GL
 Main target : Anti-Parasitics
 Drug resistance control will be a main objective.
 Inclusion of WAAVP/Australian GL into VICH framework should
be explored in collaboration with the Anthelmintics-EWG.
 Other specific combination may be a target in the future.
 After some experiences
 Further discussion by the VOF and SC members needed
Thank you
感謝