Building Bridges: Harmonization efforts for enhanced collaboration between developed and developing countries
Abstract
The harmonization efforts among regulatory bodies and stakeholders from developed and developing countries in the global healthcare landscape specifically focus on initiatives taken by CDSCO in India, MHLW in Japan, the TGA in Australia, ASEAN countries, and the US. The objective is to examine the importance of building bridges between these regions and harmonizing regulatory frameworks in the pharmaceutical and healthcare industries. The challenges faced include disparities in resources, technological capabilities, cultural differences, and regulatory frameworks. However, collaboration offers benefits such as increased access to affordable medicines, knowledge sharing, regulatory convergence, and capacity-building programs. International organizations like ICH play a role in facilitating harmonization efforts. Aligning regulatory systems and collaboration can enhance patient safety, facilitate trade, attract investment, and foster innovation. This paper concludes that harmonization efforts among CDSCO, MHLW, TGA, ASEAN countries, and the US can create a more integrated and equitable global healthcare ecosystem, bridging the gap between developed and developing countries.
Keywords:
Regulatory bodies, Harmonization, International cooperation, Regulatory Harmonization Steering Committee (RHSC), Asia-Pacific Economic Cooperation (APEC), ASEAN, PAHO, ICMRA, WHO, PANDRH, EMEA, FDA, ICH, ACESS
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References
1. Hakia’ Introduction to Regulatory Compliance: Ensuring Adherence to Industry Standards [Internet]. Hakia; 2020 Jun 21 [cited 2023 Jan 18]. Available from: https://www.hakia.com/introduction-to-regulatory-compliance-ensuring-adherence-to-industry-standards/
2. World Health Organization: Strengthening humanitarian action through evaluation and learning, Definitions: emergencies [Internet]. WHO; 2019 Dec 23 [cited 2023 Apr 18]. Available from:
https://www.alnap.org/help-library/definitions-emergencies
3. Festa G, Kolte A, Carli MR, Rossi M. Journal of Business & Industrial Marketing. Envisioning the challenges of the pharmaceutical sector in the Indian health-care industry: a scenario analysis [Internet]. Emrald Insight; 2022 Jul 29 [cited 2022 Oct 14] 37. Available from:
https://www.emerald.com/insight/content/doi/10.1108/JBIM-07-2020-0365/full/html
4. Demir I, Canakci M, Egri T. Globalization and Economic Growth [Internet]. Springer, Cham; 2021 Apr [cited 2022 Oct 11]. Available from:
https://link.springer.com/referenceworkentry/10.1007/978-3-319-71058-7_90-1
5. Toppr’ Intro and Importance of Consumer Protection [Internet]. Toppr; 2023 [cited 2023 Jan 7]. Available from:
https://www.toppr.com/guides/business-studies/consumer-protection/intro-and-importance-of-consumer-protection/
6. Cost Efficiencies: Definition, Benefits and Methods of Improvement [Internet]. Indeed; 2022 Jun 25 [cited 2022 Dec 18]. Available from:
https://www.indeed.com/career-advice/career-development/cost-efficiencies
7. Chong SSF, Kim M, Limoli M, Obscherning E, Wu P, Feisee L, et al. Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic. Ther Innov Regul Sci [Internet]. Pubmed; 2021 Jul [cited 2022 Nov 18];3. Available from:
https://pubmed.ncbi.nlm.nih.gov/33840083/
8. World Health Organization Publishes new guidance to promote Strong, Efficient and Sustainable Regulatory Systems [Internet]. TGA; 2021 Apr 29 [cited 2023 Apr 18]. Available from:
https://www.tga.gov.au/sites/default/files/international-engagement-strategy.pdf
9. Food and Drug Administration: Regulatory Harmonization and Convergence [Internet]. FDA; 2019 Jul 08 [cited 2022 Sep 11]. Available from:
https://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence
10. World Health Organization: Drug Information [Internet]. WHO; 2017 [cited 2022 Sep 18];31(3). Available from: https://apps.who.int/iris/handle/10665/330952
11. Central Drugs Standard Control Organization: Directorate General of Health Services Ministry of Health & Family Welfare Government of India, International Cell [Internet]. CDSCO; 2023 [cited 2023 May 18]. Available from:
https://cdsco.gov.in/opencms/opencms/en/International-cell1/
12. Chow WL et al. Regulatory Affairs Professionals Society New method to an old approach: A semiquantitative approach to determine the probability of regulatory success for ASEAN markets [Internet]. RAPS- Regulatory Focus; 2021 Jul 31 [cited 2022 Sep 18]. Available from:
https://www.raps.org/news-and-articles/news-articles/2021/7/new-method-to-an-old-approach-a-semiquantitative-a
13. Ministry of Health, Labour and Welfare: International Pharmaceutical Regulatory Harmonization Strategy – Regulatory Science Initiative [Internet]. MHLW; 2015 Jun 26 [cited 2022 Sep 18]. Available from:
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/150827-01.html
14. Ministry of Health, Labour and Welfare: Strategy of SAKIGAKE [Internet]. MHLW; 2014 Jun 17 [cited 2022 Nov 18]. Available from:
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/dl/140729-01-01.pdf
15. Australian Government; Therapeutic Goods Administration: International Engagement Strategy 2016-2020 [Internet]. TGA; 2016 [cited 2022 Dec 18]. Available from:
https://www.tga.gov.au/sites/default/files/tga-international-engagement-strategy-2016-2020.pdf
16. Australian Government; Department of Health and Aged Care; Therapeutic Goods Administration: International engagement strategy 2021-2025 [Internet]. TGA; 2021 Jul 26 [cited 2022 Sep 18]. Available from:
https://www.tga.gov.au/resources/publication/publications/tga-international-engagement-strategy-2021-2025
17. Australian Government; Department of Health Aged Care; Therapeutics Goods Administration: Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium [Internet]. TGA; 2023 May 16 [cited 2023 Jul 18]. Available from:
https://www.tga.gov.au/international-activities/australia-canada-singapore-switzerland-united-kingdom-access-consortium
18. International Coalition of Medicines Regulatory Authorities [Internet]. ICMRA; 2023 [cited 2023 Aug 18]. Available from:
https://icmra.info/drupal/en/home
19. International Coalition of Medicines Regulatory Authorities: Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility [Internet]. ICMRA; 2021 Jun 11 [cited 2023 Jan 11]. Available from:
https://icmra.info/drupal/sites/default/files/2021-06/pqkms_statement.pdf
20. International Coalition of Medicines Regulatory Authorities (ICMRA) FACT SHEET [Internet]. ICMRA; 2014 Sep [cited 2022 Dec 18]. Available from:
https://www.tga.gov.au/sites/default/files/icmra-fact-sheet.pdf
21. Food and Drug Administration: Globalization [Internet]. FDA; 2023 Jul 31 [cited 2023 Aug 18]. Available from: https://www.fda.gov/international-programs/fda-globalization
22. Food and Drug Administration: International Arrangements [Internet]. FDA; 2023 Aug 24 [cited 2023 Sep 1]. Available from:
https://www.fda.gov/international-programs/international-arrangements
23. Food and Drug Administration: Partnerships and Collaboration [Internet]. FDA; 2023 Jun 02 [cited 2023 Jun 18]. Available from:
https://www.fda.gov/international-programs/partnerships-and-collaboration
24. World Health Organization: Regulation and Prequalification [Internet]. WHO; 2023 May 02 [cited 2023 May 18]. Available from:
https://www.who.int/teams/regulation-prequalification/regulation-and-safety
25. Food and Drug Administration: The Future of FDA’s Electronic Safety Surveillance [Internet]. FDA; 2021 Sep 01 [cited 2023 Jan 18]. Available from:
https://www.fda.gov/news-events/fda-voices/future-fdas-electronic-safety-surveillance
26. Food Drug Administration: Regulatory Harmonization and Convergence [Internet]. FDA; 2018 Jan 01 [cited 2023 Apr 11]. Available from:
https://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence
27. Pan America Health Organization: Communicable Diseases and Environmental Determinants of Health [Internet]. PAHO; 2023 [cited 2023 Apr 18]. Available from:
https://www3.paho.org/hq/index.php?option=com_content&view=article&id=5797:cde-related-sites&Itemid=0&lang=en#gsc.tab=0
28. Pan America Health Organization: Noncommunicable Diseases [Internet]. PAHO; 2023 [cited 2023 Apr 18]. Available from:
https://www.paho.org/en/topics/noncommunicable-diseases
29. Pan American Health Organization: Family, Health Promotion and Life Course [Internet]. PAHO; 2023 [cited 2023 Mar 22]. Available from:
https://www.paho.org/en/family-health-promotion-and-life-course
30. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Centralized Procedure with European Medicines Agency [Internet]. EMA; 2019 Apr [cited 2023 Mar 28]. Available from:
https://www.ema.europa.eu/en/documents/other/monitoring-adequacy-implementation-adherence-international-council-harmonisation-technical_en.pdf
31. Patel P, Badjatya JK, Hinge M. Comparative study of Regulatory requirements of Drug Product in Emerging market. Int J Drug Reg Affairs [Internet]. 2019 Sep. 15 [cited 2023 Apr. 17];7(3):48-2. Available from:
https://ijdra.com/index.php/journal/article/view/350
32. Ghangas J, Jain N, Sinha A. A critical view of harmonization of regulatory requirements for Generic Drug approval submissions in ASEAN countries. Int J Drug Reg Affairs [Internet]. 2019 Mar. 16 [cited 2023 Apr. 18];7(1):13-4. Available from:
https://ijdra.com/index.php/journal/article/view/297
33. Antoine Serge A, J.C. Y, Pola E Y, Jean-Yves P. Comparative study of the harmonization of pharmaceutical regulations in the western and central sub-regions of Africa. Int J Drug Reg Affairs [Internet]. 2018 Dec.20 [cited 2023 Apr. 14];6(4):46-1. Available from:
https://ijdra.com/index.php/journal/article/view/288
34. Badjatya JK, Jangid A, Dodiya P, Soni S, Parekh A, Patel D, Patel J. Comparative study of Regulatory requirements of Drug Product in Emerging market. Int J Drug Reg Affairs [Internet]. 2022 Mar. 15 [cited 2023 Apr. 14];10(1):51-2. Available from:
https://ijdra.com/index.php/journal/article/view/510
35. Badjatya JK, Bodla R. HARMONIZATION & ADVANCEMENT IN PHARMACEUTICAL INDUSTRY. Int J Drug Reg Affairs [Internet]. 2018 Feb. 6 [cited 2023 Apr. 13];1(2):7-10. Available from:
https://ijdra.com/index.php/journal/article/view/4
36. GUIET MATI F, Ousmane A, AMONKOU - N’GUESSAN AC, TRAPSIDA J-M, SONDE I, ELH MAMANE M, AMARI SA, PABST J-Y. Pharmaceutical Regulation in Niger in 2021: Significant advances with the Harmonization Process. Int J Drug Reg Affairs [Internet]. 2022 Dec. 15 [cited 2023 Apr. 12];10(4):75-7. Available from:
https://ijdra.com/index.php/journal/article/view/566
2. World Health Organization: Strengthening humanitarian action through evaluation and learning, Definitions: emergencies [Internet]. WHO; 2019 Dec 23 [cited 2023 Apr 18]. Available from:
https://www.alnap.org/help-library/definitions-emergencies
3. Festa G, Kolte A, Carli MR, Rossi M. Journal of Business & Industrial Marketing. Envisioning the challenges of the pharmaceutical sector in the Indian health-care industry: a scenario analysis [Internet]. Emrald Insight; 2022 Jul 29 [cited 2022 Oct 14] 37. Available from:
https://www.emerald.com/insight/content/doi/10.1108/JBIM-07-2020-0365/full/html
4. Demir I, Canakci M, Egri T. Globalization and Economic Growth [Internet]. Springer, Cham; 2021 Apr [cited 2022 Oct 11]. Available from:
https://link.springer.com/referenceworkentry/10.1007/978-3-319-71058-7_90-1
5. Toppr’ Intro and Importance of Consumer Protection [Internet]. Toppr; 2023 [cited 2023 Jan 7]. Available from:
https://www.toppr.com/guides/business-studies/consumer-protection/intro-and-importance-of-consumer-protection/
6. Cost Efficiencies: Definition, Benefits and Methods of Improvement [Internet]. Indeed; 2022 Jun 25 [cited 2022 Dec 18]. Available from:
https://www.indeed.com/career-advice/career-development/cost-efficiencies
7. Chong SSF, Kim M, Limoli M, Obscherning E, Wu P, Feisee L, et al. Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic. Ther Innov Regul Sci [Internet]. Pubmed; 2021 Jul [cited 2022 Nov 18];3. Available from:
https://pubmed.ncbi.nlm.nih.gov/33840083/
8. World Health Organization Publishes new guidance to promote Strong, Efficient and Sustainable Regulatory Systems [Internet]. TGA; 2021 Apr 29 [cited 2023 Apr 18]. Available from:
https://www.tga.gov.au/sites/default/files/international-engagement-strategy.pdf
9. Food and Drug Administration: Regulatory Harmonization and Convergence [Internet]. FDA; 2019 Jul 08 [cited 2022 Sep 11]. Available from:
https://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence
10. World Health Organization: Drug Information [Internet]. WHO; 2017 [cited 2022 Sep 18];31(3). Available from: https://apps.who.int/iris/handle/10665/330952
11. Central Drugs Standard Control Organization: Directorate General of Health Services Ministry of Health & Family Welfare Government of India, International Cell [Internet]. CDSCO; 2023 [cited 2023 May 18]. Available from:
https://cdsco.gov.in/opencms/opencms/en/International-cell1/
12. Chow WL et al. Regulatory Affairs Professionals Society New method to an old approach: A semiquantitative approach to determine the probability of regulatory success for ASEAN markets [Internet]. RAPS- Regulatory Focus; 2021 Jul 31 [cited 2022 Sep 18]. Available from:
https://www.raps.org/news-and-articles/news-articles/2021/7/new-method-to-an-old-approach-a-semiquantitative-a
13. Ministry of Health, Labour and Welfare: International Pharmaceutical Regulatory Harmonization Strategy – Regulatory Science Initiative [Internet]. MHLW; 2015 Jun 26 [cited 2022 Sep 18]. Available from:
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/150827-01.html
14. Ministry of Health, Labour and Welfare: Strategy of SAKIGAKE [Internet]. MHLW; 2014 Jun 17 [cited 2022 Nov 18]. Available from:
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/dl/140729-01-01.pdf
15. Australian Government; Therapeutic Goods Administration: International Engagement Strategy 2016-2020 [Internet]. TGA; 2016 [cited 2022 Dec 18]. Available from:
https://www.tga.gov.au/sites/default/files/tga-international-engagement-strategy-2016-2020.pdf
16. Australian Government; Department of Health and Aged Care; Therapeutic Goods Administration: International engagement strategy 2021-2025 [Internet]. TGA; 2021 Jul 26 [cited 2022 Sep 18]. Available from:
https://www.tga.gov.au/resources/publication/publications/tga-international-engagement-strategy-2021-2025
17. Australian Government; Department of Health Aged Care; Therapeutics Goods Administration: Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium [Internet]. TGA; 2023 May 16 [cited 2023 Jul 18]. Available from:
https://www.tga.gov.au/international-activities/australia-canada-singapore-switzerland-united-kingdom-access-consortium
18. International Coalition of Medicines Regulatory Authorities [Internet]. ICMRA; 2023 [cited 2023 Aug 18]. Available from:
https://icmra.info/drupal/en/home
19. International Coalition of Medicines Regulatory Authorities: Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility [Internet]. ICMRA; 2021 Jun 11 [cited 2023 Jan 11]. Available from:
https://icmra.info/drupal/sites/default/files/2021-06/pqkms_statement.pdf
20. International Coalition of Medicines Regulatory Authorities (ICMRA) FACT SHEET [Internet]. ICMRA; 2014 Sep [cited 2022 Dec 18]. Available from:
https://www.tga.gov.au/sites/default/files/icmra-fact-sheet.pdf
21. Food and Drug Administration: Globalization [Internet]. FDA; 2023 Jul 31 [cited 2023 Aug 18]. Available from: https://www.fda.gov/international-programs/fda-globalization
22. Food and Drug Administration: International Arrangements [Internet]. FDA; 2023 Aug 24 [cited 2023 Sep 1]. Available from:
https://www.fda.gov/international-programs/international-arrangements
23. Food and Drug Administration: Partnerships and Collaboration [Internet]. FDA; 2023 Jun 02 [cited 2023 Jun 18]. Available from:
https://www.fda.gov/international-programs/partnerships-and-collaboration
24. World Health Organization: Regulation and Prequalification [Internet]. WHO; 2023 May 02 [cited 2023 May 18]. Available from:
https://www.who.int/teams/regulation-prequalification/regulation-and-safety
25. Food and Drug Administration: The Future of FDA’s Electronic Safety Surveillance [Internet]. FDA; 2021 Sep 01 [cited 2023 Jan 18]. Available from:
https://www.fda.gov/news-events/fda-voices/future-fdas-electronic-safety-surveillance
26. Food Drug Administration: Regulatory Harmonization and Convergence [Internet]. FDA; 2018 Jan 01 [cited 2023 Apr 11]. Available from:
https://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence
27. Pan America Health Organization: Communicable Diseases and Environmental Determinants of Health [Internet]. PAHO; 2023 [cited 2023 Apr 18]. Available from:
https://www3.paho.org/hq/index.php?option=com_content&view=article&id=5797:cde-related-sites&Itemid=0&lang=en#gsc.tab=0
28. Pan America Health Organization: Noncommunicable Diseases [Internet]. PAHO; 2023 [cited 2023 Apr 18]. Available from:
https://www.paho.org/en/topics/noncommunicable-diseases
29. Pan American Health Organization: Family, Health Promotion and Life Course [Internet]. PAHO; 2023 [cited 2023 Mar 22]. Available from:
https://www.paho.org/en/family-health-promotion-and-life-course
30. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Centralized Procedure with European Medicines Agency [Internet]. EMA; 2019 Apr [cited 2023 Mar 28]. Available from:
https://www.ema.europa.eu/en/documents/other/monitoring-adequacy-implementation-adherence-international-council-harmonisation-technical_en.pdf
31. Patel P, Badjatya JK, Hinge M. Comparative study of Regulatory requirements of Drug Product in Emerging market. Int J Drug Reg Affairs [Internet]. 2019 Sep. 15 [cited 2023 Apr. 17];7(3):48-2. Available from:
https://ijdra.com/index.php/journal/article/view/350
32. Ghangas J, Jain N, Sinha A. A critical view of harmonization of regulatory requirements for Generic Drug approval submissions in ASEAN countries. Int J Drug Reg Affairs [Internet]. 2019 Mar. 16 [cited 2023 Apr. 18];7(1):13-4. Available from:
https://ijdra.com/index.php/journal/article/view/297
33. Antoine Serge A, J.C. Y, Pola E Y, Jean-Yves P. Comparative study of the harmonization of pharmaceutical regulations in the western and central sub-regions of Africa. Int J Drug Reg Affairs [Internet]. 2018 Dec.20 [cited 2023 Apr. 14];6(4):46-1. Available from:
https://ijdra.com/index.php/journal/article/view/288
34. Badjatya JK, Jangid A, Dodiya P, Soni S, Parekh A, Patel D, Patel J. Comparative study of Regulatory requirements of Drug Product in Emerging market. Int J Drug Reg Affairs [Internet]. 2022 Mar. 15 [cited 2023 Apr. 14];10(1):51-2. Available from:
https://ijdra.com/index.php/journal/article/view/510
35. Badjatya JK, Bodla R. HARMONIZATION & ADVANCEMENT IN PHARMACEUTICAL INDUSTRY. Int J Drug Reg Affairs [Internet]. 2018 Feb. 6 [cited 2023 Apr. 13];1(2):7-10. Available from:
https://ijdra.com/index.php/journal/article/view/4
36. GUIET MATI F, Ousmane A, AMONKOU - N’GUESSAN AC, TRAPSIDA J-M, SONDE I, ELH MAMANE M, AMARI SA, PABST J-Y. Pharmaceutical Regulation in Niger in 2021: Significant advances with the Harmonization Process. Int J Drug Reg Affairs [Internet]. 2022 Dec. 15 [cited 2023 Apr. 12];10(4):75-7. Available from:
https://ijdra.com/index.php/journal/article/view/566
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How to Cite
Raut, N., K. Bajaj, P. Matte, M. Vhora, V. Kale, M. Umekar, and S. Harane. “Building Bridges: Harmonization Efforts for Enhanced Collaboration Between Developed and Developing Countries”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 3, Sept. 2023, pp. 68-79, doi:10.22270/ijdra.v11i3.622.
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