Comparative Regulatory Requirements and Strategic Decisions for Asean Markets for Topical and Nasal Route Dosage Forms

Abstract

Introduction: Regulatory frameworks for topical and nasal dosage forms in ASEAN (Association Southeast Asian Nations) countries remain fragmented, creating challenges for pharmaceutical companies pursuing multi-country approvals.

Objectives: To evaluate and compare the regulatory requirements for topical and nasal dosage forms across ASEAN markets, and to propose strategic approaches for effective regulatory submissions.

Methods Regulatory documents and market-specific guidelines were reviewed for all ten ASEAN member states, supported by insights from practical submissions and case examples.

Results: Distinct differences were identified in dossier format adherence, reference product criteria, bioequivalence expectations, and country-specific documentation and testing norms.

Conclusions: Country-specific regulatory strategies, supported by harmonization tools such as ACTD and Mutual Recognition Arrangements (MRAs-In the ASEAN region, MRAs are part of efforts to promote regulatory convergence, reduce duplication, and expedite product approvals across member states), are essential for accelerating approvals across ASEAN.