GROUP 1 CAMEVET Singapore Tanzania —

GROUP 1 CAMEVET – Singapore – Tanzania - Thailand 1

Application of VICH GLs and acceptance of studies conducted according to VICH GLs Africa: • Experience from human side: ICH was very active in training, went very far in assisting implementation in the field, e. g. regulators working with regulators • Exchange between regulators very efficient with regard to acceptance/application (example: Zazibona – Zambia, Zimbabwe, Botswana, Namibia, S. Africa, Tanzania, DR Congo) • How to be effective in the region: experience from human side very useful, e. g. joint assessment between countries • Awareness and training is very critical – many countries still do not know yet about VICH 2

Application of VICH GLs and acceptance of studies conducted according to VICH GLs ASEAN : • Partnership with OIE was very useful for many countries in ASEAN accepting VICH GLs • Expect better buy-in into using VICH GLs if regional organisations such as ASEAN are approached • Already have ASEAN standard for vaccines => very open to refer to VICH GLs as standard • Level of technical knowledge varies between countries => speed of uptake of GLs will vary dependent on maturity of regulatory system 3

Application of VICH GLs and acceptance of studies conducted according to VICH GLs ASEAN – how to efficiently reach out? • Agreed at last meeting to have VICH join the next meeting to inform the group about latest developments and train them • Create awareness with countries not actively participating to VOF, stimulate interest in VICH • ASEAN agreed in 2014 to refer to VICH GLs, ministers agreed, but no real push since them • Start with most relevant GLs (quality) for training, particularly stability (example: today problems in Thailand with low quality of some products that may be related to stability) 4

Application of VICH GLs and acceptance of studies conducted according to VICH GLs Further proposals as to how to efficiently reach out: • Focus resources 1. 2. 3. 4. Awareness of GLs Use of GLs Understanding specific legal framework of country/region Assist in applying GLs Awareness • New media such as “You Tube” could be used for awareness raising – no technical issues with that • Lack of communication between OIE Focal Points and local regulatory authorities – outreach not always efficient 5

Application of VICH GLs and acceptance of studies conducted according to VICH GLs Further proposals as to how to efficiently reach out (cont’d): Training • Usually training information disseminated by Focal Points • For actual training on GLs need to define how to best achieve that – audience different from Focal Points • Need right technical competence – several individuals in each country • Prioritisation of training in line with major needs identified and specific needs of country/region – adaptation to specific needs is important, countries are at different levels 6

Application of VICH GLs and acceptance of studies conducted according to VICH GLs ICH experience - Tanzania • Much involvement in ICH as observer (EAC, SADC) since 2004 – SADC country representation varies from one meeting to another, all feel involved, disseminate information, communicate after meetings • WHO role in setting up training • Zazibona experience: WHO also assisted with the IT platform – facilitated joint/parallel dossier evaluation • Political buy-in in the countries/regions already exists from the human side – build on that • Veterinary side still lagging behind 7

Application of VICH GLs and acceptance of studies conducted according to VICH GLs Recommendations from ICH experience - Tanzania: • Involvement in particular of regional economic groupings in VOF discussions, will foster acceptance • Training, training • Translations of GLs (e. g. need Portuguese version of GLs) 8

Application of VICH GLs and acceptance of studies conducted according to VICH GLs - Individual country/region experience - 9

Application of VICH GLs and acceptance of studies conducted according to VICH GLs CAMEVET : • Conducted survey on use of VICH GLs • Most used GLs: Stability and GCP • GLs used as technical reference (includes also ICH), not referred to in legislation • The more mature a registration system in a country, the less willingness to accept VICH GLs instead of local GLs • Look at equivalency of GLs to increase acceptability of VICH GLs? => offer VICH GLs as “working document” to countries to foster acceptance as referential document • In general acceptance of VICH GLs has been increasing over time 10

Application of VICH GLs and acceptance of studies conducted according to VICH GLs CAMEVET – challenges: • Level of training of assessors within regulatory authorities • Frequent turnover of agency staff • “GLs are GLs” – need to have agreement on how to apply: – E. g. to which products, particularly in regions where there is no differentiation between new and generic products – Example: efficacy trials requested for vaccines for which decades of use experience • Training being organised – first phase to be presented next week 11

Application of VICH GLs and acceptance of studies conducted according to VICH GLs Tanzania: • Use VICH GLs as reference even if no reference in legislation • Depend much on imported products, which fosters reference to international standards • The tune is to harmonise between regions Singapore: • Will follow ASEAN recommendation on VICH GLs – see no particular problems in using VICH GLs as firm point of reference 12

Application of VICH GLs and acceptance of studies conducted according to VICH GLs Thailand : • No specific vet GLs • In general acceptance of VICH GLs, even if no official notification yet 13

Application of VICH GLs and acceptance of studies conducted according to VICH GLs S. Africa : • Always referred to VICH – generally accepted • Aligned with EMA, FDA, Australia (incl. refering to Public Assessment Reports in evaluating/approving new products) • Have a TF (authorities/industry) to work on implementation • SADC (regional community of about 14 countries) asked S. Africa to draft GLs for the region – perceived as too technically demanding and replaced by more general GLs, referring to VICH • In general much interest by SADC, including joining VICH Outreach Forum; S. Africa feels it should take the lead in driving this process with SADC 14

Waiving of Target Animal Batch Safety Testing (TABST) - Status in individual countries/regions - 15

Application of VICH GLs and acceptance of studies conducted according to VICH GLs CAMEVET : • Dependent on country: usually in countries with strong industry official batch release exists, particularly for vaccination campaigns (e. g. brucellosis, rabies) • No release tests for pharmaceuticals Tanzania : • Do not have official batch release testing • Interesting to learn the experiences from the other countries/regions 16

Application of VICH GLs and acceptance of studies conducted according to VICH GLs Thailand : • For TABST Thailand proposed to other ASEAN countries such as Philippines and Singapore to adopt the TABST GL at the next ASEAN meeting (takes place every 12 months) Singapore: • See no particular problems in using VICH GLs as firm point of reference 17