Around the Globe

Digitalization in the ASEAN Pharmaceuticals Market
Soon Yee Chow
Helene Sou
Takeda
@TakedaPharma
O

ne key pillar of the Association of Southeast Asian Nations (ASEAN) as outlined in the (draft) ASEAN Pharmaceutical Regulatory Policy (APRP) is that:

“ASEAN Member States should seek to ensure that unnecessary regulatory and administrative barriers to intra-ASEAN trade are eliminated. There should be established cooperation and information exchange between regulatory authorities and relevant stakeholders to combat the movement of substandard and falsified pharmaceutical products within the ASEAN region.”

Furthermore, in 2021, ASEAN issued an official statement reinforcing the importance of digitalization across all sectors. This article focuses on several ongoing digital initiatives in ASEAN in the pharmaceutical sector and will highlight the status of implementation, including some challenges, in the region. In this sector, there is a wide variety of opportunities to achieve the benefits of digitalization. Digitalization can be used to optimize the drug development process and timelines through use of novel digital endpoints in clinical trials and use of digital health tools and technologies (DHTs) to collect patient data and facilitate decentralized trials.

Digitalization can also help achieve a higher efficiency in regulatory processes; e.g., through secured data sharing among regulators and applicants, virtual inspections/audits, and electronic submissions. It may also be applied in the drug supply chain to reduce the risk of counterfeit through serialization.

ASEAN and eCTD

The use of electronic Common Technical Documents (eCTD) was first introduced in 2003 and has now become the standard format for regulatory submission in major markets such as the US, Europe, and Japan. The eCTD format features a common folder structure, table of contents, and an XML backbone to enable the lifecycle of files for a product application to be managed individually. eCTD implementation brings multiple advantages to industry and regulatory authorities. It allows easy access and navigation to the information. eCTD also facilitates information exchange and the regulatory review process, lessening the burden of paper processing, and offer greater consistency and transparency in data management. However, adoption of a common eCTD format in ASEAN is still low, due to the existence of various country-specific requirements and health authorities’ expectations towards the harmonized approach. Presently, only Thailand accepts the eCTD format, while Singapore and Malaysia accept electronic submissions in CTD format through their own online system. In the Philippines, submission is done mainly via email, while digitalization of the submission portal is underway to accommodate online dossier submissions. In some instances, physical paper and DVD submission are still required in certain countries.

ASEAN and Cloud-Based Platforms

Cloud-based platform applications broadly cross several regulatory contexts. They are used in pharmacovigilance and safety alert systems, clinical trial information systems, disease and patient registries, and real-world data tracking. In ASEAN, cloud-based platforms have been in use for several years for post-marketing safety monitoring purposes. Indeed, the ASEAN Post-Market Alert System is used for more timely sharing of information related to post-approval product safety and quality, and to enhance pharmacovigilance capabilities through mutual exchange of safety data among ASEAN member states. Implementation of a cloud-based platform is envisioned as a future strategy to enable more dynamic and fluid exchange of information between regulatory agencies and industry and help accelerate the regulatory review process. Simultaneous regulatory submissions, reviews, and approvals among multiple regulatory agencies could be made possible by the use of a compatible cloud data system which allows transmission of large data sets on a real-time basis. In ASEAN, the Pharmaceutical Product Working Group (PPWG) Joint Assessment Coordinating Group (JACG) is tasked to develop an IT platform (“Joint Assessment Information Management System”) to facilitate the joint review of priority medicines and to foster reliance and mutual recognition of regulatory decisions among ASEAN member states.

ASEAN and eLabelling

Another ongoing initiative is use of eLabelling to electronically disseminate product information to healthcare professionals and patients. eLabelling entails using URL, QR code, 2D code, or other machine-reading code website URL on the packaging, which will link to a secure online system that publishes the package inserts and patient information leaflets in a digital format.

Adopting electronic labels in replacement of, or in addition to, the paper product information would expand and expedite HCP and patient access to the most up-to-date product information (which is a challenge for paper labels), and reduce the cost and environmental impact of printing. eLabelling could also help improve labelling content consistency across countries.

In ASEAN, harmonization and adoption of eLabelling is underway. The concept of eLabelling was proposed by the ASEAN Pharmaceutical Research Industry Association (APRIA) at the 21st PPWG Implementation Working Group (IWG) in June 2019, and an APRIA eLabelling position paper was submitted for discussion at the 22nd IWG in July 2020. Singapore was the first country in ASEAN to publish a guidance on electronic labelling for Therapeutic Products in August 2019, which outlined a phased approach starting with prescription-only medicines. In Malaysia, eLabelling is piloted for select COVID-19 vaccines. Industry and trade associations in Malaysia, Thailand, and the Philippines have started to form working groups to seek collaboration with health authorities in advancing eLabelling implementation readiness.

ASEAN and Product Serialization

Another application of digitalization is to help secure the product supply chain from counterfeit products by introducing serialization and “Track and Trace” (T&T). T&T involves encoding individual bottles or packages with unique serial numbers. The serial number information, as well as the expiration dates, Global Trade Item Number (GTIN), and lot numbers, are encoded in bar codes affixed to the product packages, enabling traceability of drug products throughout the supply chain from product manufacturers to end customers. This increased level of traceability helps secure the supply chain by ensuring that only products with valid serial numbers reach patients.

Indonesia is the first ASEAN member state to introduce pilot implementation of serialization: By 2025, all prescription products must be serialized and equipped with an authentication barcode containing GS1 GTIN, marketing authorization number, batch number, expiration date, and serial number. Meanwhile, Malaysia is moving forward with their plan for full implementation in 2023, and Singapore is also exploring the use of GS1 2D barcodes.

Conclusions

These digital initiatives, if implemented appropriately across ASEAN, can contribute to ASEAN’s vision of a free-trade market for high-quality and safe drugs across member states. Challenges remain in the different levels of economic development and infrastructure among the 10 ASEAN countries; in addition, concerns about cybersecurity threats and data privacy protection remain in countries where pertinent laws may not be robust and require establishing high-level health data policies.

Progress in the process of digitalization across ASEAN is promising. While a few countries have taken the lead on implementing digital initiatives in the pharmaceutical sector, this may require major investment and take years to achieve for others. Efforts should continue in a coordinated way with the lead countries supporting other countries in building digitalization capabilities and increasing trust on data handling across ASEAN.

The Association of Southeast Asian Nations (ASEAN) was founded in 1967 and is currently comprised of 10 member countries (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam).
References available upon request.

Acknowledgement:

The authors thank the Asia Pacific Digital Health & Data Consortium (ADDC) for their contribution in the review of this article. The ADDC is a group of industry partners established to serve as a platform for collaboration between industry and other organizations such as policy think tanks and regulators to shape digital health data frameworks in the Asian-Pacific region.
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