The Asia-Pacific (APAC) region is a rapidly growing hub for pharmaceutical innovation and generic drug development. The increase in demand for generic drugs is due to their low cost and equivalent safety and efficacy to branded drugs. The APAC region incorporates a wide range of regulatory frameworks, from highly developed frameworks of stringent regulatory authorities (SRAs) in countries like Japan and Australia to those frameworks of nations where the regulatory landscape is still evolving- such as Vietnam and Indonesia. The scattered regulatory framework with the country-specific requirements creates obstacles to the entry of new drug products because no single market represents the entire region. In recent years, more regulatory agencies in the APAC region have become more active in ICH, becoming observers, or full members.
Recent Trends in the APAC Region
The APAC region is implementing regulatory reforms to expedite approval processes. The countries are adopting regulatory reforms according to international guidelines. Following are the updates and recent developments in various APAC countries to shape the regulatory landscape:
Japan
Japan is one of the founding members of the International Council on Harmonization (ICH), and since starting it has represented the region. It not only advocates for developing a robust regulatory framework in the country, but it also has been proactive on an international level. SaMD Guidelines: Revised guidelines from the Ministry of Health clarify the distinction between software as a medical device (SaMD) and non-SaMD, facilitating the launch of innovative healthcare software.
Sakigake Designation: Introduced to accelerate the development of innovative drugs for urgent medical needs.
Conditional Early Approval System: This system permits early access to drugs intended for life-threatening conditions where no alternate therapies exist.
Indonesia
Omnibus Health Law: Enacted in August 2023, this law incentivizes local R&D in pharma and medical devices and outlines regulations for telemedicine and foreign medical personnel, while granting the central government authority over drug pricing.
Singapore
SRA Recognition: The Health Sciences Authority received recognition as a Stringent Regulatory Authority (SRA), expediting WHO prequalification for In Vitro Diagnostics (IVDs) approved by the HSA, thereby enhancing global market access for high-risk IVD products.
Singapore is planning a transition to electronic Common Technical Document (eCTD) submissions for drug applications in 2025, aiming to modernize and streamline the registration process.
South Korea
Digital Medical Product Act: Passed in December 2023, this act regulates digital medical products throughout their lifecycle, including clinical trials and post-marketing management. Companies will need to disclose the economic benefits provided to healthcare professionals starting August 2024.
The Ministry of Food and Drug Safety (MFDS) has received the World Health Organization (WHO) Listed Authority designation and introduced the Global Innovative Products on Fast Track (GIFT) pathway for expedited product approvals. Additionally, MFDS co-hosted an international symposium on AI in medical products with the U.S. FDA.
Vietnam
Smart Healthcare Initiatives: The government is promoting telemedicine through legislative support like Circular 49. There is an ongoing effort to adapt regulations to align with evolving digital health technologies following the pandemic.
Vietnam introduced Circular No. 08/2022/TT-BYT to streamline drug registration processes. This circular simplifies requirements for the Certificate of Pharmaceutical Product (CPP) and reduces stringency in CPP requirements.
Australia
Recently, the Therapeutic Goods Administration (TGA) Amended classification rule 5.5, which will apply from July 1, 2024, affecting medical devices containing microbial, recombinant, or animal substances. New applications must adhere to these amended rules, while existing ones will need reclassification by July 1, 2026.
The TGA launched a pilot Single Inspection Program in February 2024, a global approach to GMP inspections, in collaboration with Health Canada and the UK Medicines & Healthcare Products Regulatory Agency. The program aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest, reducing the need for multiple inspections of the same site. This builds on existing collaborative GMP arrangements, allowing for more efficient inspection reliance processes, reduced regulatory burden on industry, and enhanced collaboration in global supply chain oversight.
India
To streamline the regulatory submission, the CDSCO has initiated an online submission process for PSURs related to new drugs, subsequent new drugs, fixed-dose combinations, biologicals, and veterinary products through the Sugam portal at https://cdscoonline.gov.in.
In another update, CDSCO has created a draft Guidance for the industry, “Post Approval Changes in Biological Products: Quality Safety and Efficacy Document,” in collaboration with stakeholders to align with international guidelines and regulatory practices. The guidance aims to categorize modifications made to biological products approved by CDSCO for import/manufacturing and marketing in India and provide recommendations for Marketing Authorization Holders (MA holders) regarding the required data for assessing the impact on the product’s quality.
Approaches to Strengthen Regulatory Systems in the Asia-Pacific
When marketing a drug product in the APAC region, pharmaceutical companies face multiple challenges, as the result of which hampers patient safety. The fragmented regulatory framework, with each country having its own set of requirements for drug approval. This leads to the delay of a drug product in the market. Another challenge is intellectual Property Rights (IPR) issues, which create barriers for pharmaceutical companies, leading to legal challenges and operational risks. Most National Regulatory Agencies (NRAs) don’t have sufficient incentives and frameworks to promote innovation in regulatory practices. Also, most APAC countries face challenges due to a lack of trained personnel and resources. This lack of resources hinders effective drug regulation.
To address these challenges, establishing training programs, and improving resources are crucial to enhance regulatory knowledge and skills of personnel within the agencies.
Countries are implementing regulatory harmonization initiatives to streamline drug approval processes. Initiatives like the Association of Southeast Asian Nations (ASEAN) Common Technical Document (ACTD) aim to create a unified framework for drug approval, simply the process for pharmaceutical companies to enter into multiple markets.
Another strategy that strengthens the system is the regulatory reliance which allows NRAs to recognize the assessments made by other regulatory bodies, thereby streamlining the approval process for medical devices and pharmaceuticals. The Singapore Health Sciences Authority and the Thai Food and Drug Administration have successfully implemented a pilot program demonstrating this approach, resulting in reduced approval times for medical devices.
Conclusion
The regulatory landscape in the APAC region is a dynamic mix of challenges and opportunities. As the APAC region continues to evolve, staying informed about regulatory updates is crucial for strategic planning. By understanding regional trends, promoting collaboration, and leveraging innovation, pharmaceutical companies navigate this complexity effectively and capitalize on the growing market potential.
Ready to tackle the evolving regulatory landscape? Start by reviewing your drug development strategy to align with APAC-specific requirements. Reach out to regulatory experts today to guide your journey to APAC drug development.
In addition to providing regulatory and pharmacovigilance services for global customers, DDReg Pharma offers specialized clinical regulatory services to assist with Clinical Trial Applications in the United States. For further information, connect with our experts. Read more about medical device regulations from the experts here: A Guide to Using FDA’s eSTAR for Medical Device Submissions