Regulatory convergence or harmonisation? Exploring regional approaches for streamlining chemistry manufacturing and control variations and its application in Latin America compared to initiatives in Southeast Asia

Essiam, Ivy 2024. Regulatory convergence or harmonisation? Exploring regional approaches for streamlining chemistry manufacturing and control variations and its application in Latin America compared to initiatives in Southeast Asia. PhD Thesis, Cardiff University. Item availability restricted.

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Abstract

Post-approval chemistry, manufacturing and control changes (PACs) are essential in the lifecycle of a medicinal product in improving quality and maintaining supply. In recent years, the focus of harmonisation or convergence initiatives are beginning to shift to PACs due to the divergent regulations between different National Regulatory Authorities (NRAs) and the resulting complexity it brings to maintaining quality and supply. The benefits of streamlining PAC requirements and regulations across regions, for industry, NRAs and ultimately patients is widely accepted. The aims of this research were threefold. The first was to explore and assess the effectiveness of harmonisation of PACs among three ASEAN markets, namely Malaysia, Singapore and Thailand. Secondly, the research aimed to assess whether streamlining of PACs was a priority in six Latin America markets (LATAM), namely Argentina, Brazil, Chile, Colombia, Cuba and Mexico; and to ascertain whether streamlining was occurring through ‘harmonisation within the region’ or ‘convergence to international guidelines’. Lastly, the research compared the ASEAN harmonisation initiative with the LATAM experience to determine any areas of strength from ASEAN which could be applied to LATAM. A qualitative case study approach including a systematic review, online questionnaires, group and individual interviews was adopted to achieve the research objectives. The perspectives of the Regulatory Affairs Professionals stakeholder group and harmonisation network was obtained by individual interviews. In parallel, perspectives of one LATAM industry association was obtained via group interview. An online questionnaire was complete by personnel with LATAM NRA working experience and followed up with either an online or email interview. The ASEAN interviews showed that the main motivations for harmonised requirements were trade, security and a unified mindset. However, despite their harmonisation initiatives, challenges remained for effective implementation which led some participants to believe that convergence was a better process to associate with the streamlining initiatives in ASEAN. The LATAM interviews and questionnaires exposed the low priority the region had for streamlining chemistry, manufacturing and control (CMC) requirements. The results also confirmed that convergence through reliance was the best model to describe streamlining efforts across the region, in spite of various challenges. Harmonisation could possibly occur across the region as each market converges to international guidelines, however, this may take a long time due to challenges such as political rivalry and lack of a unified mindset. The comparison between ASEAN and LATAM showed similar challenges across the two regions which could be an indication of regions which have markets with varying degrees of disparity in regulatory capacity and expertise. The LATAM region, however, has much to learn from ASEAN’s united goal of leverage across markets to support becoming an economic bloc plus the desire for patients to have access to quality and innovative medicines.

Item Type:	Thesis (PhD)
Date Type:	Completion
Status:	Unpublished
Schools:	Pharmacy
Subjects:	Q Science > Q Science (General)
Date of First Compliant Deposit:	22 April 2024
Last Modified:	22 Apr 2024 13:26
URI:	https://orca.cardiff.ac.uk/id/eprint/168197

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