This article discusses current diverging regulations for probiotics as ingredients in foods and dietary supplements and the trends and translational science that have demonstrated probiotic benefits. It emphasizes how aligning a global probiotic harmonized regulatory framework can help navigate the confusion around the regulations to ensure global consumer access to beneficial products of quality.   Keywords – Codex, harmonization, regulations, probiotics, probioti...

Welcome to the December issue of RF Quarterly which focuses on key takeaways from RAPS Convergence 2021, including patient-focused approaches in regulatory decision making and drug development, the transition from convergence to harmonization for global pharmaceutical regulatory requirements, pediatric drug development, and regulatory and clinical strategies.   Patient perspective and global harmonization There is increasing recognition of the importance of patients...

This article examines the transition from convergence to harmonization for global pharmaceutical regulatory requirements. It outlines the roles of International Council for Harmonisation (ICH) and World Health Organization (WHO) in the implementation of ICH guidances and provides definitions for convergence and harmonization to reflect their distinctive roles. The authors also address ongoing harmonization initiatives, the current degree to which implementation has or has ...

Regulators from the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) discussed how medical device sponsors can get approval for global studies accepted into the regulators’ joint “harmonization by doing” (HBD) program.   The program is designed to save development time and costs in developing life-saving cardiovascular devices through the simultaneous review of global studies, explained Shin Iwamoto, a PMDA principal r...

This issue marks the 6th annual RAPS series on nutrition in health and disease management, and the gut microbiome, in which global experts write about food, nutrition, and dietary supplements from regulatory, trade, marketing, and legal perspectives. In keeping with the series, articles in the current issue examine US Food and Drug Administration (FDA) regulatory guidance and requirements, especially regarding dietary supplements, bioengineered products, probiotics, and CO...

Many countries in the Association of Southeast Asian Nations (ASEAN) require registration of health supplements, which generally takes a few months to years. There have been many different interpretations of the principle-based standards or regulations among the ASEAN member nations, making right-first-time regulatory submissions for the region hard to achieve and, absent defined review limits (such as rounds of questions/letters of deficiencies), lead times for approvals ...

With the expanding globalization of drug development, regulations put forth under the International Council for Harmonisation’s (ICH’s) M10 guidance support the transition to a more harmonized industry. The draft guidance marks another step of integrating international expectations, in this case, as it applies to bioanalytical evaluations. This article examines the key elements of the M10 standard and recommends strategies for successful new drug or clinical trial applicat...

Welcome to the summer issue of RF Quarterly in which international experts from the UK, EU, Saudi Arabia, Hong Kong, and the US have come together to examine and dissect the role of artificial intelligence (AI) in healthcare and its impact on global regulatory practice.   Advances in AI technologies are transforming healthcare delivery and hold promise for improving patient outcomes. However, these complex technologies have introduced new challenges, especially aroun...

Human tissue is newly introduced to the scope of the EU Medical Device Regulation (EU MDR). Although it offers the opportunity for uniform market access of device/tissue products, lack of clarity and borderline challenges remain and are centered on linking a harmonized device framework with a nonharmonized human tissue framework. Concerns include a shortage in the number of available notified bodies, decentralized regulatory oversight for tissues, and absence of an “Articl...

To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...

The World Health Organization (WHO) finalized a report on combating antimicrobial resistance (AMR), stressing the urgency to act. The final report—developed by the Interagency Coordination Group on Antimicrobial Resistance (IACG)—identifies 14 recommendations centered on the urgency and action needed for a global fight against AMR. “The challenges of antimicrobial resistance are complex and multifaceted, but they are not insurmountable,” WHO said, arguing the report’...

Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to participate. A new working group (WG) was established to take up new work on IVDs and was approved at the last International Medical Device Regulators Forum (IMDRF) management committee meeting in Russia in March. A new category for interested countries to participate in MDSAP ...