AAHA

AAHA ASEAN Regulatory Benchmark Study 2020 Report

The ASEAN Animal Health Regulatory Benchmarking Survey 2020 report summarises the findings of the first assessment of the regulatory environment in ASEAN markets. The survey was conducted over two years by an independent market research company which collected qualitative and quantitative data through one-on-one interviews and on-line questionnaires with local and multi-national regulators, government regulatory officials and independent regulatory consultants. The report lists key findings at ASEAN and national level and provides recommendations for mutually beneficial improvements, enhancements and efficiencies. The survey did identify clear opportunities for best practice and knowledge sharing, talent development and process harmonisation. Additionally specific issues around Free Sales Certificate requirements and regulatory fee structures were highlighted as opportunities to reduce regulatory timelines and improve resourcing at departmental level. It is the aim of AAHA that all stakeholders can work constructively with this first report to enhance regulatory outcomes and ultimately improve access to new and innovative medicines for ASEAN veterinarians, producers and consumers.

The key takeaways from the study were:

  • Regulatory agencies are staffed by scientifically sound, ethical and engaged professionals
  • Opportunities exist for best practice sharing, training and talent development
  • Opportunities to review fee structure to improve resources and outcomes
  • Harmonization possible in defined areas, e.g., site inspections reports, documentation, testing SOPs, etc
  • Increased dialogue between all stakeholders is encouraged
  • Requirement for Free Sales Certificate (FSC/CPP) at the time of the dossier submission delays the regulatory approval and access to new products
  • Adoption of digital tools/e-dossiers is a positive development

 

1. ASEAN AH Regulatory Survey (Region) Phase 1&2

2. ASEAN AH Regulatory Survey (Cambodia) Phase 1&2

3. ASEAN AH Regulatory Survey (Indonesia) Phase 1&2

4. ASEAN AH Regulatory Survey (Malaysia) Phase 1&2

5. ASEAN AH Regulatory Survey (Myanmar) Phase 1&2

6. ASEAN AH Regulatory Survey (Philippines) Phase 1&2

7. ASEAN AH Regulatory Survey (Thailand) Phase 1&2

8. ASEAN AH Regulatory Survey (Vietnam) Phase 1&2

9. ASEAN AH Regulatory Survey (Region) Phase 3&4 – part 1a

9. ASEAN AH Regulatory Survey (Region) Phase 3&4 – part 1b

9. ASEAN AH Regulatory Survey (Region) Phase 3&4 – part 1c

9. ASEAN AH Regulatory Survey (Region) Phase 3&4 – part 1d

9. ASEAN AH Regulatory Survey (Region) Phase 3&4 – part 1e

10. ASEAN AH Regulatory Survey (Region) Phase 3&4 – part 2

If you have any enquiries or feedback email us at ABS@asiananimalhealth.org

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