1. Session 1 - Agenda Item 5.: OIE
Dr Mária Szabó
Chargée de mission
VICH Guideline Survey Results for Outreach Forum Countries
7th VICH Outreach Forum meeting
Brussels, June 2016  

2. Session 1 - Agenda Item 5.: OIE
Background
Overview
VICH - Extent of Uptake -VICH Study Acceptance
VICH Training Priorities
CONCLUSION

3. Session 1 - Agenda Item 5.: OIE
Decision from the 6th VICH Outreach Forum Tokyo October: Conduct of a Survey by the OIE and HealthforAnimals in VICH –OUTREACH FORUM (VOF)-OIE Member Countries
During the last 6th VICH Outreach Forum a decision was taken to conduct a joint survey by OIE and HealthforAnimals among the VICH-Outreach Forum Countries. The goal was to obtain a general view of the current situation of the VICH Outreach Forum Countries, the ASEAN, CAMAVET and UEMOA region. We included also Saudi Arabia, UGANDA who became the member of the VOF countries in the meantime, we wish you a warm welcome !

4. Session 1 - Agenda Item 5.: OIE
OIE: Letter with the questionnaire was sent to the Delegates and their National Focal Points for VMPs to all VICH – VOF Member Countries, ASEAN, CAMAVET and UEMOA A simplified questionnaire was prepared for the Regional Focal Points Seminars (Asia , the Far East and Oceania-Tokyo and French Speaking Africa-Dakar-March 2016) HealthforAnimals conducted its survey separately
The OIE sent a letter and the same questionnaire/survey as HealthforAnimals conducted, but this was sent to the Delegates and National Focal Points. A simplified questionnaire was used in the Regional Focal Point Seminars.

5. Session 1 - Agenda Item 5.: OIE
The main aim of the survey :
Evaluate the level of the VICH activities
The level of acceptance and implementation of VICH Guidelines (GLs)
Priorities for the next training sessions on VICH GLs
The objectives of the Survey:
1)to evaluate the level of VICH activities, the acceptance and implementation of VICH GLs
2) to set up priorities for the next training
3) to provide support to the training implementation subgroup
4) to obtain a general view of the current situation of the VICH Outreach Forum Countries

6. Session 1 - Agenda Item 5.: OIE
Responses-OVERVIEW
Letter with Survey were sent directly to 17 Countries (Argentina, Brazil , China, India, Korea, Malaysia, Mexico, Morocco, Russia, Saudi Arabia, Singapore, South Africa, Taipei (Chinese), Taiwan, Thailand, Uganda, Ukraine, ) on the deadline of 29 March 2016
ASEAN, CAMEVET and UEMOA
Responses received : Argentina, Morocco, Saudi Arabia, Thailand, Taipei (Chinese ), Uganda, Ukraine and UEMOA ( Benin, Burkina Faso, Ivory Coast, Guinee- Bissau, Mali, Niger, Senegal, Togo )-7plus 8 Member Countries (MC)-15 MCs
Additional responses obtained country by country from the Regional Seminars (Asia, the Far East and Oceania –31 Member Countries, French Speaking Africa-24 Member Countries )
The letter explaining the rationale and the aim of the Survey, was sent directly to 17 Member Countries and ASEAN, CAMEVET and UEMOA. Additional responses obtained from the Regional Seminars which took place in Asia and French speaking Africa.

7. Session 1 - Agenda Item 5.: OIE
Responses-OVERVIEW
Responses are available from the first channel:7 MCs plus UEMOA : 8 MCs: 15 countries
Responses are available from the second channel: 55 countries-from the simplified questionnaire used in the 4th Cycle Regional Seminars
Altogether: 70 countries but focus in the first part on the first channel result similar to HealthforAnimals presentation

8. Session 1 - Agenda Item 5.: OIE
Responses-OVERVIEW
HealthforAnimals : Number of Companies: 4
Number of Countries :16
Responses usually similar, occasional divergences
HealthforAnimals obtained responses by 4 Companies, altogether from 16 Countries; the VOF members. They did not seek responses from organisations representing multiple countries e.g. UEMOA

9. VICH - Extent of Uptake- VOF Members
Session 1 - Agenda Item 5.: OIE
VICH - Extent of Uptake- VOF Members
Extent of acceptance
OIE
(15 MCs)
plus UEMOA 8 MCs
HealthforAnimals (16 MCs) [%]
Countries that have adopted one or more GL, without modification
4 ( UEMOA-8 MCs) MO, UG, UKR
4 [25]
Countries that have adopted one or more GL with modification 4
AR, TP-CH, UG, UKR
4 [25]
Countries that have adopted one or more GL with or without modification 8
(7 MCs plus UEMOA -8 MCs)
6 [38]
Countries that accept studies performed to one or more GL 6
(AR, TP-CH, UG, TH, UKR, UEMOA-8 MCs)
10 [63]
Total number of GL in responding countries adopted with or without modification 79
[9]
Total number of GLs in responding countries where studies are accepted
[50]
Information is on one slide for convenience, but you can’t direct compare the numbers between OIE and HealthforAnimals as responding countries differed.
The UEMOA countries, Morocco, Uganda and Ukraine adopted one or more GL without modification.
Argentina, Chinese Taipei, Uganda, Ukraine have adopted one or more guidelines with modifications. Countries that accept studies performed to one or more VICH GL: Argentina, Uganda, Thailand, Ukraine and Chinese Taipei and UEMOA countries.
HealthforAnimals obtained responses for all of the VOF member countries. It is positive to see that considering all the GLs (remember there are now 51 in total), 50% of the time, studies performed according to these GLs are accepted. But it is also possible to see the potential to achieve so much more, with only 9% adoption of the GLs (and this adoption is important as it improves predictability).

10. Session 1 - Agenda Item 5.: OIE
VICH Study Acceptance
Extent of acceptance
Country
For most of the GLs if studies to VICH GL they are accepted
TH (51) AR (41), UKR (36)
UG (34), UEMOA (30)
AR, IND, MAL, M0, SA, TA,TU, UG
For some of the GLs if studies to VICH GL they are accepted
TP-CH, (13)
KO, MEX, TH,
For only the occasional GL if studies to VICH GL they are accepted
n/a-for OIE
Brazil
No VICH studies accepted
n/a – for OIE
China and Ukraine
On this slide you can see the extent of the VICH Study acceptance.
One significant difference is seen between the industry and regulator results. This is for Ukraine. One the one hand industry indicates VICH studies are not accepted as it is specified the rules in the country must be followed, on the other hand the regulator indicates for more than 2/3rds of VICH GLS they will accept the studies. Perhaps this message has not got through to the industry and needs to be promoted. To a less extent a difference in views is also seen for Thailand. Key message: Lets do more to promote the adoption of guidelines as well as making it transparent which VICH GLs are adopted and/or accepted in individual countries.

11. Plan for adoption of further VICH Guidelines
Session 1 - Agenda Item 5.: OIE
Plan for adoption of further VICH Guidelines
Countries which are planning to adopt many Guidelines:
Saudi Arabia (42)
Ukraine (42)
Chinese Taipei (22)
Countries which are planning to adopt many GLs : SA (42) , TP-CH (22), UKR (42), -Uganda (22) ;
This is an important and significant result, why ? On the next two slides from HealthforAnimals you can see the country specific requirements:

12. Results from Industry (1)
Session 1 - Agenda Item 5.: OIE
Results from Industry (1)

13. Results from Industry (2)
Session 1 - Agenda Item 5.: OIE
Results from Industry (2)

14. VICH Training Priorities – overall
Session 1 - Agenda Item 5.: OIE
VICH Training Priorities – overall
Ranking
(1-2 OIE, Industry 3 categories)
GL Number
Topics
Highest Priority OIE :
1-2-3,-4-5, 9, 11, 22, 23, 24, 27 29, 30, 35, 39, 40, 42, 48, 52
Method, validation definition, validation, stability, GCP, impurities in products, reproductive tox, genotoxicity, pharmacovigilance ESTD, PSURs, AMR, quality specification, metabolism and residue kinetics, bioequivalence
Medium to High
OIE :
1, 6- 38, 27, 28, 42, 46, 49, 51, 54
Validation definition, ERA – phase 1, -(phase-II) carcinogenicity, AMR, Phvg data elements, residues (food), Stats for stability, ArfD
Medium
3, 4, 8, 24, 43, 45
Stability (x 5), target safety – pharms, pharmacovigilance – AERs
Rating based on number of responses and how high they rated it. The highest priority = 1 or 2 ranking for OIE. I highlighted with red colour the OIE finding/results. The HealthforAnimals finding are indicated with grey. In the priority, in general: Quality, safety and pharmacovigilance related guidelines are the most interested topics.
Generally – priorities depend on countries but clear evidence shows: the high interest on quality, safety and pharmacovigilance GLs

15. VICH Training Priorities – OIE Regional Seminar (1)
Session 1 - Agenda Item 5.: OIE
VICH Training Priorities – OIE Regional Seminar (1)
Tokyo 1-3 March 2016
2 countries indicated that further discussion is required on the priority in the home country
Many countries except (Chinese Taipei, Japan, Korea RO, Micronesia, Mongolia, Nepal) do not know well the GLs and functioning
Divergent interest
One country (Mongolia) is interested in receiving training on all VICH Guidelines
The following countries are interested to join VICH Outreach Forum : Mongolia, Cambodia, Sri Lanka
It is not so easy to conclude the priorities of the training. But the message is clear: it is needed more general, regulatory training on VICH GLs in this Region (Asia, the Far East and Oceana and find support to Mongolia ? Myanmar and Malaysia need financial support as well

16. VICH Training Priorities – OIE Regional Seminar (2)
Session 1 - Agenda Item 5.: OIE
VICH Training Priorities – OIE Regional Seminar (2)
Dakar March-2016
In French speaking Africa the guidelines of most interest for training are in terms of quality: GL1 and GL2-validation definition and methodology, GL3-4 stability, G10–impurities substances guidelines which reflect the problem of the quality of drugs :
Safety: GL29 Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports(PSUR) and  GL48  Metabolism and Residue kinetic GL- to establish withdrawal periods! which is one of the basic guidelines in terms of ensuring food safety.
The summary of the questionnaire from the Dakar seminar in March 2016  as the additional information.  The evaluation clearly indicated that for the French speaking Africa the most interested guidelines for training the quality guidelines :
GL1 and GL2-Validation definition and methodology, GL3-4 stability, G10 –impurities substances- which reflect to the problem of the quality of drugs  and consequence of the other interest , namely:
Safety : GL 29 –Pharmacovigilance of Veterinary Medicinal Products : Management of Periodic Summary Update Reports(PSUR), and  GL48  Metabolism and Residue kinetic-to provide guidance to establish withdrawal periods ! which is the basic guideline in terms to ensure food safety.

17. VICH Training Priorities – OIE Regional Seminar (3)
Session 1 - Agenda Item 5.: OIE
VICH Training Priorities – OIE Regional Seminar (3)
Dakar March-2016
Following the seminar:
GL27 Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance is on the priority list in 6 out of 24  countries.
The Republic of Guinea indicated their interest in the guideline in terms of Ecotox Phase I, (ERA)
The Republic of the Congo indicated that after this seminar they would to be interested to join the VICH Outreach Forum !!!
GL  27-Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance is on the priority list in 6  countries out of 24.
Republique de Guinee indicated the interest of the Ecotox Phase I, (ERA) which is really surprising and appreciated.
Congo Republic indicated after this seminar that would like to join the VICH Outreach Forum.

18. VICH Training Priorities
Session 1 - Agenda Item 5.: OIE
VICH Training Priorities
CONCLUSION
Nil novi sub sole/nothing is new under the sun/ rien de nouveau sous le soleil.
First priority for training: QUALITY
Second: SAFETY
Third: EFFICACY Guidelines
3 key aspects of the evaluation of veterinary medicinal products in order to assure good quality, safe and efficient veterinary medicinal products on the market
What has been will be again,    what has been done will be done again;    there is nothing new under the sun.

19. Session 1 - Agenda Item 5.: OIE
And your precious CONTRIBUTION ! Member Countries (AR, MO, SA, TH, TP-CH, UG, UKR) and UEMOA 8 MCs (Benin, Burkina Faso, Ivory Coast, Guinee- Bissau, Mali, Niger, Senegal, Togo ) and Health for Animals, especially to Dr Jackie Atkinson who made the evaluation and prepared a great presentation on behalf of Industry and to Mr. Rick Clayton.