Regulatory agility key to faster access to life-saving medicines

Access to life-saving medicines often depends not only on scientific breakthroughs, but on how quickly and efficiently regulatory systems can evaluate and approve them.

National regulatory authorities (NRAs) such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) play a vital role in safeguarding public health. They ensure that medicines, vaccines, and medical devices meet stringent standards of safety, efficacy, and quality before and after reaching the market. Without these safeguards, patients would be exposed to unsafe or ineffective products, and trust in healthcare systems would erode.

At the same time, modern healthcare demands more than protection as it requires speed, adaptability, and global coordination. The research-based pharmaceutical industry works closely with NRAs to strengthen regulatory systems, accelerate access to innovative therapies, promote reliance on trusted regulatory decisions, and maintain the highest standards of quality and safety. These efforts include addressing bottlenecks, harmonizing standards such as Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), and improving preparedness for public health emergencies.

The COVID-19 pandemic demonstrated what is possible when regulatory systems evolve. NRAs and the biopharmaceutical industry adopted flexible and iterative approaches to accelerate the development, evaluation, authorization, and distribution of vaccines and diagnostics. What once took years was achieved in record time, without compromising safety.

These regulatory agilities included the use of digital tools, decentralized clinical trials, and rolling reviews of data. Equally important was the unprecedented level of collaboration among regulators, industry, and international platforms such as the International Coalition of Medicines Regulatory Authorities (ICMRA). This alignment enabled faster decision-making and more efficient deployment of critical health technologies.

A key enabler of this speed was regulatory reliance. Under this approach, one regulatory authority considers and gives significant weight to the scientific assessments or approvals of another trusted authority or institution, such as the World Health Organization (WHO), while maintaining its own independent decision-making.

A notable example was the WHO Emergency Use Listing (EUL), a risk-based mechanism used during public health emergencies to evaluate unlicensed vaccines, therapeutics, and diagnostics. Recognition of the WHO EUL allowed countries to expedite national authorizations, make efficient use of limited regulatory resources, avoid duplication, and accelerate patient access to COVID-19 vaccines.

“To ensure the availability of COVID-19 vaccines and RT-PCR test kits in the country during the pandemic, we worked closely with the Philippine FDA, the Department of Health, and embassies of several countries to expedite regulatory processes and navigate border closures,” said Dr. Diana Edralin, president of the Pharmaceutical and Healthcare Association of the Philippines (PHAP).

Dr. Edralin emphasized that ensuring Filipinos have timely and sustained access to quality medicines remains a key priority, requiring close collaboration between government and industry.

“Enhancing access to innovative medicines in the country requires a dynamic, resilient, and responsive regulatory system. This is why PHAP promotes the adoption of global best practices in pharmaceutical regulation from Europe, North America, and Southeast Asia,” she added.

The lessons from the pandemic are clear. However, regulatory flexibility should not be limited to emergencies. Applying these best practices in routine settings can significantly shorten the time it takes for patients to benefit from new therapies.

Expedited pathways such as Fast Track, Breakthrough Therapy, and Accelerated Approval allow faster access to medicines that address serious conditions or unmet medical needs, while maintaining rigorous safety standards. Meanwhile, the use of Electronic Common Technical Document (eCTD) formats, along with digital tools for compliance tracking and document management, can improve efficiency, reduce errors, and streamline submissions.

At the regional level, the Philippines’ ASEAN Chairmanship presents a strategic opportunity to advance the ASEAN Harmonization of Pharmaceutical Registration. This initiative seeks to align technical requirements and regulatory processes across member states, facilitating trade while ensuring the safety, quality, and efficacy of medicines.

Key mechanisms such as the ASEAN Common Technical Dossier (ACTD) and the ASEAN Pharmaceutical Regulatory Framework (APRF) help reduce duplication, lower regulatory costs, and enable faster access to medicines across Southeast Asia. Together, they represent an important step toward a more integrated and efficient regional regulatory system.

Ultimately, improving access to innovative medicines requires regulatory systems that are not only robust, but also adaptive. By embracing reliance, harmonization, and digital transformation, countries like the Philippines can accelerate access to life-saving therapies while upholding the highest standards of patient safety.

In doing so, regulatory excellence becomes not just a safeguard but a catalyst for better health outcomes.