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, 21 - 22 June 2016  

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

Session 1 - Agenda Item 5.: OIE Decision from the 6th VICH Outreach Forum Tokyo 25-30 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 !

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.

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

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 9-02-2016 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.

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

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

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 78 [9] Total number of GLs in responding countries where studies are accepted 430 [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).

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.

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:

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

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

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

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

VICH Training Priorities – OIE Regional Seminar (2) Session 1 - Agenda Item 5.: OIE VICH Training Priorities – OIE Regional Seminar (2) Dakar 21-23 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 21-23 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.

VICH Training Priorities – OIE Regional Seminar (3) Session 1 - Agenda Item 5.: OIE VICH Training Priorities – OIE Regional Seminar (3) Dakar 21-23 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.

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.

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.