everaging digital technologies (e.g., artificial intelligence), regulatory optimization strategies (e.g., reliance mechanisms), and innovative clinical trial methodologies remain key to accelerating patient access to medicines in Asia. These approaches are especially critical for less developed Health Authorities (HAs) with limited resources in addressing review timelines and enhancing access to innovative therapies. This was the consensus among all participants and presenters at the DIA Singapore Annual Meeting 2025.

Moreover, with increasing innovative therapies (e.g., radioligand therapy, cell therapy, and gene therapy) and rapid development of digital technologies, it was generally agreed that it is imperative for HAs to continue to collaborate closely with industry stakeholders in order to remain adaptable while ensuring that safe, high-quality medicines continue to be accessible to patients.

Regulatory Excellence and Regulatory Reliance

More HAs in Southeast Asia are recognizing the benefits of regulatory reliance and have either begun piloting or have already implemented it in their respective countries. For example, recently revised local legislation in Vietnam introduced a reliance registration pathway with a shorter 9-month approval timeline compared to the 12-month timeline for the full evaluation pathway. Other HAs utilizing regulatory reliance have reported that this mechanism has reduced drug approval timelines, optimized resource use, and enabled near-simultaneous submissions across multiple markets. Examples of reliance programs include the World Health Organization (WHO) Collaborative Registration Procedure (CRP), WHO Stringent Regulatory Authority (SRA) CRP, Association of Southeast Asian Nations (ASEAN) Joint Assessments (JA), and national pilots in individual countries for post-approval changes (PAC). The Thailand Food and Drug Administration (FDA) was able to reduce the approval timeline of new drugs and biologics by 130 working days by using the WHO SRA CRP as a result of close collaboration with WHO and direct communication with the reference HA.

Similarly, in one global pharmaceutical company’s PAC reliance pilot, the organization leveraged a single assessment report from a reference HA (the European Medicines Agency) to reduce global approval timelines from 2.5 years to 6.5 months.

A shift in reviewers’ mindsets, which ensures that reviewers do not “default” to a full review but recognize that regulatory reliance maintains scientific rigor while enabling greater efficiency with the same resources, is also essential. To further maximize the benefits of regulatory reliance, HAs should consider waiving country-specific requirements such as additional testing and submission of certificate of pharmaceutical product.

With stakeholders acknowledging the value of regulatory convergence and harmonization, several HAs (e.g., Thailand FDA and Hong Kong Department of Health) have expressed interest in becoming International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulatory members and recognize the importance of having the same or similar standards. Furthermore, convergence or harmonization of requirements could further enhance the impact and appeal of ASEAN Joint Assessments. Nonetheless, HAs emphasized that certain local requirements, such as epidemiological data and climatic zone-specific stability studies, remain essential to ensure product quality, safety, and efficacy for local populations.

Transformative Digitalization and Application of AI

Digitalization continues to be a central theme in Asia’s regulatory evolution. HAs are adopting electronic package inserts, structured content management systems, cloud-based submission platforms, and real-time collaboration tools to support HA processes. These innovations are enabling more efficient lifecycle management, facilitating both reliance and work-sharing regulatory pathways, while improving transparency for both regulators and applicants.

For example, the Singapore Health Sciences Authority has implemented “EasiShare,” a cloud-based file exchange platform for application dossier submission, and plans to implement the eCTD portal in the next 12 months to enable a more structured, standardized, secure transmission of dossiers between industry and regulators.

The Drug Administration of Vietnam has implemented a fully online portal for pharmaceutical applications, including renewals and post-approval changes. This digital system has improved efficiency, reduced administrative costs, and enabled 100% of submissions to be processed electronically, supporting transparency and alignment with international standards.

Artificial intelligence (AI) and machine learning are also being explored across regulatory affairs and pharmacovigilance. One global pharmaceutical company has already implemented several use cases, including AI-powered inbox screening for adverse event (AE) detection and semantic listening for patient sentiment analysis. Their project in China, which utilized AI to enable immediate AE identification and structuring, demonstrated that AI can be a powerful tool when used purposefully, localized, and implemented in close collaboration with key stakeholders such as hospitals and HAs.

Similarly, the Thailand FDA is using AI to review medical device applications, employing natural language processing and optical character recognition to extract and analyze data. This has reduced backlog, improved consistency, and enhanced application quality.

Despite the advancement of AI, responsible governance remains essential. Transparency, explainability, and human oversight for all key decisions remain critical safeguards, particularly when AI is used to support regulatory decisions.

Clinical Trial Innovation

Southeast Asia continues to see robust growth in clinical trials, with the contract research organization market in the region projected to reach USD 31.10 billion by 2030. HAs are keen to sustain the continued growth by streamlining processes, introducing reforms, or adopting international guidelines. In Indonesia, the establishment of Clinical Research Units and regulatory reforms such as the streamlining of the Material Transfer Agreement process have reduced clinical trial start-up timelines from 9 to 12 months to 4 to 7 months.

More HAs in Asia are implementing or are planning to implement the ICH E17 guideline on Multi-Regional Clinical Trials (MRCTs) in their respective countries. For example, the Taiwan Center for Drug Evaluation has adopted ICH E17 and applied a structured approach to assess pooling strategies and regional consistency. In their evaluation of finerenone, the authority’s analysis supported the pooling of East Asian data and demonstrated no clinically relevant differences, thus enabling approval without the need for additional local data.

Nonetheless, challenges such as ambiguity in defining regional groups, lack of clarity around pooling strategies, and determining appropriate sample size allocations still exist. Early engagement between sponsors and HAs remains the best way to clarify expectations on these issues, align on trial design, and facilitate global development.

Key Takeaways

Even as regulatory reliance is maturing, with broader adoption and clear successes in WHO CRP, ASEAN JA, and PAC pilots, changing the mindset of HAs remains essential to ensure successful implementation of regulatory reliance in these areas:

• Digital transformation enables faster internal HA processes and facilitates closer coordination among HAs from different markets.
• AI could be integrated into regulatory and pharmacovigilance workflows, but it is imperative to ensure there is human oversight throughout.
• ICH E17 implementation is advancing, but further alignment is needed on pooling strategies and regional definitions.

Looking Ahead

Close partnership and collaboration between regulators and industry remains essential. Stakeholders should integrate digital tools into their processes, embrace regulatory optimization (e.g., reliance registration pathways or regulatory convergence), and apply AI purposefully and responsibly to accelerate the delivery of innovative and safe therapies to patients.

The authors thank Wong Kum Cheun and Agnes Heng for their valuable contributions to this article.

Disclaimer: The opinions expressed in this article are solely those of the contributors and not necessarily those of Novartis. Novartis does not guarantee the accuracy or reliability of the information provided herein.