Meeting Highlights: DIA China 2021

Global Pharmaceutical Regulation Evolving and Modernizing to Protect Public Health
Handsome Ji

he key priorities to modernize regulatory science are to optimize the regulatory system, encourage scientific innovation, and develop cross-cutting talents. By opening interdisciplinary conversations and studying the similarities and differences among regional regulatory policies, health authorities and scientists will be able to protect and promote the health of all populations.

The Global Regulatory Modernization Town Hall at DIA China 2021 aligned with the conference theme of Integrating into Globalization, New Journey to Innovation as representatives from four major regulatory authorities–the (China) National Medical Products Administration (NMPA), the US Food & Drug Administration (FDA), the European Medicines Agency (EMA), and the (Japan) Pharmaceuticals and Medical Devices Agency (PMDA)–shared strategies for building regulatory capacity building during the next three to five years.

Regulatory Robustness and Modernization

A series of important policies enacted in the past five years by the NMPA is a particularly prominent model for reforming pharmaceutical regulations. On May 10, 2021, the NMPA outlined their opinions on comprehensively consolidating China’s capabilities in regulations, with special emphasis on accelerating efforts to establish and improve a scientific and efficient system for pharmaceutical supervision. This opinion revealed the Chinese government’s intent to achieve modernization of the drug regulatory system in the near future. Revised parliamentary Acts implemented by the PMDA also reflect Japan’s determination in regulatory modernization. The new Acts to regulate medical products and devices enable the expedited review and approval process for innovative products. Diverse accelerated review programs, such as Sakigake and Conditional Early Approval, allow applicants to submit their requests based on compelling innovations that can benefit patients and address unmet patient needs.

During the COVID-19 pandemic, a set of rapid response measures exemplified operational excellence within regulatory systems and the potential for improving flexibility and efficiency. Health authorities published various guidances to support the sustainability of research and development with a focus on making the vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) available to patients at the earliest possible time. FDA and PMDA proved to be flexible regarding drug inspections and willing to carry out the work in a remote manner. Public transparency of scientific information was also enhanced during the pandemic; for instance, FDA and PMDA promptly disclosed safety and adverse event reports of vaccines to build and sustain public confidence in health authorities.

Scientific and Technological Development and Innovation

NMPA has stressed that a professional regulatory system requires evidence-based knowledge as its foundation, with sound technology support. Different health authorities are seeking technological innovation and applications in different areas. For example, the EMA strategic plan for the next five years focuses on converging technology in various disciplines, including catalyzing the combination of technological and medical development and driving collaborative efforts to collect scientific evidence. This plan also aims to improve the scientific quality of reviews and promote research and innovation in regulatory science.

Digital business transformation and data analysis is also becoming a critical imperative, and several countries have fully prepared to implement supporting technologies. For example, Japan is about to become the first country in the world to implement eLabeling, which is expected to start on August 1, 2021, and be fully adopted in two years. FDA has also leveraged emerging technologies to launch several technical projects such as 3-D printing and the Knowledge-aided Assessment & Structured Application (KASA system). These are just a few use cases demonstrating the high importance of implementing scientific innovations in regulatory frameworks.

Interdisciplinary Collaboration and Capacity Enhancement

Interdisciplinary collaboration and communication will continue to drive the modernization of regulatory science. For example, as mentioned in their five-year plan, EMA will work closely with healthcare sectors to advance patient-centricity and drug accessibility. NMPA will further strengthen China’s international collaborations on drug regulation and efforts to harmonize regulatory standards. PMDA targets regional-specific diseases and emphasizes the importance of Asian populations to participate in early phase clinical trials, and has also called for collaboration among regulatory authorities in Asia to leverage real-world data to advance the approval process of innovative products. COVID-19 has reemphasized the urgency of communication among all sectors, and PMDA has initiated closer dialogue with industry to highlight practical cases for approval under EUA (Emergency Use Authorization). FDA has similarly reinforced timely connections among academic institutions, manufacturers, and regulators.

While the COVID-19 pandemic amplified the demands and challenges for regulatory innovation, it did not keep healthcare professionals or the industry from moving forward. Instead, the pandemic inspired the continuous exchange of ideas through different channels and innovative solutions to protect public health. A combination of digital and medical technologies (e.g., artificial intelligence and mRNA science) supported by regulatory policy is no longer a dream. Regulatory process optimization, scientific innovation, and interdisciplinary talent acquisition will be the future of regulatory science. With an adequate scientific basis and solid strategic planning, we are working toward a brighter future.

The author thanks the chair and presenters from
Global Regulatory Modernization Townhall: Regulatory Modernization to Protect Public Health

Session Chair
Lili Cao, Deputy Director of International Exchange Center, NMPA

Anthony Humphreys
Head of the Scientific Committees Regulatory Science Strategy, EMA

Qiong Qiu
Deputy Director of Policies and Regulations Department, NMPA

Vanessa Shaw-Dore
Director of China Representative Office, FDA

Uzu Shinobu
Senior Executive Director and International Project Lead, PMDA