EFPIA foreword: As we look back the recently concluded meetings of  ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) that has existed since 35 years, we can only feel proud and privileged to be a founding member of this organisation where scientific experts have been developing some of the gold standards for the pharmaceutical industry that is recognised worldwide today.  This blog captures the positive and tangible impacts that global, multilateral organisations such as ICH have on pharmaceutical regulatory activities, ultimately benefiting patients worldwide with high-quality, safe and efficacious medicines.

In an era where research, development and regulatory review of medicines traverse borders, achieving global alignment is not just a nice-to-have, it is essential for timely patient access to innovation. A recent publication between Sanofi and the CIRS examines how regulatory pathways across multinational jurisdictions now increasingly converge on shared standards that shape the global development of medicines.

Why harmonization matters?

The power of regulatory harmonization lies in its ability to build trust between regulatory authorities. When countries adopt common technical standards, particularly ICH guidelines, and implement consistent good practices (GxP), they develop similar risk-based approaches and can display similar levels of maturity. This mutual understanding creates the foundation for reliance pathways, where one regulatory authority can leverage the assessment work of another trusted counterpart while keeping their independency in decision making process.

The study found that jurisdictions more engaged with international organizations show higher usage of reliance pathways. This makes intuitive sense as alignment with global standards reduces the need for duplicative reviews, streamlining submission processes, and ultimately accelerating patient access. The "WHO-listed authorities" initiative (WHO-Listed Authority (WLA)) further reinforces this trust-based system by identifying regulatory bodies that consistently apply similar level of regulatory requirements.

The message is clear – harmonization is a win for innovation, patients and health systems alike. And harmonisation is facilitated in countries belonging to a global regulatory organisation.

A comprehensive analysis of global regulatory activities by international organizations

This recent publication examined 316 projects undertaken between 2018 and 2024 involving six major international regulatory organizations: ICH, WHO, PIC/S, IPRP, ICMRA, and IMDRF.

The research shows that these organizations concentrate their efforts on four critical areas: quality assurance (24.4% of activities), public health (19.9%), convergence and reliance (14.2%), and pharmacovigilance (9.5%). Importantly, emerging priorities such as digital health and innovative therapies are also gaining traction, demonstrating that the regulatory framework is evolving alongside scientific innovation. Most of these activities (55.4%) result in guidance development to continuously improve the regulatory systems, while developing training is also actively pursued by some of these organisations.

Overall, the data show that countries more active in organizations like ICH and WHO tend to have higher proportions of applications submitted through reliance routes (verification/abridged review). The study also reveals that joining ICH correlates with reduced submission lag, with significant improvements seen in China (-622 days), Brazil (-289 days), and Indonesia (-279 days). This suggests that alignment with international standards and technical guidelines builds trust, harmonizes regulatory processes, and ultimately streamlines the drug approval pathway, though the causal direction may work both ways—reliance adoption may also encourage participation in these international bodies.

Amongst these different organisations, it is to be noted that the ICH structure offers the most compelling co-creation model that offers opportunities for multi-stakeholder participation of regulators and industry experts working together from the earliest stages of guideline development. The process permits industry to share scientific insight, practical constraints, global development experience, data-driven input and expertise on technological advances in research and development.

International collaboration as an imperative

The evidence is clear: international regulatory collaboration is highly valuable for patients and all regulatory stakeholders. It reduces duplication, accelerates timelines, and ultimately benefits patients through faster access to safe and effective medicines. The complementary nature of activities across organizations demonstrates that the global regulatory ecosystem is well structured with each organization contributing its unique expertise to the collective mission.

But challenges remain. Not all countries have equal access to or representation in these international organizations. Regional harmonization initiatives can help bridge this gap as a first step in harmonisation, reliance and trust, enabling broader participation in global regulatory development. The study shows that countries involved in regional initiatives tend to participate in more international organizations, creating pathways for more regulatory authorities to engage with global standards.

Most critically, the continued voice of the pharmaceutical industry in shaping global regulatory frameworks is important. As regulatory stakeholders face emerging challenges—from pandemic preparedness to digital therapeutics for personalized medicine, a collaborative approach to product development becomes even more essential.

For European companies & members of EFPIA operating global development programs, the ability to develop medicines according to internationally accepted guidelines such as those drafted by ICH means that submissions in EU and international authorities are convergent with global development. This helps reduce fragmentation, divergent standards and unnecessary regulatory burden. From the EFPIA perspective, the future of pharmaceutical regulation is global, harmonized, and collaborative. By continuing to strengthen international partnerships all stakeholders can ensure to build a regulatory system that serves its ultimate purpose: delivering innovative medicines to patients faster.