In May 2012, the leaders of 30 medicine regulatory bodies from around the world gathered at the 65th World Health Assembly in Geneva, collectively puzzling over how to improve cooperation among them.

Their answer came later that year: form the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary group of Heads of Agency (HoA) leaders collectively and strategically focused on the biggest current and emerging global human medicine regulatory and safety challenges.

The ICMRA is now considered a strategic cross-border leader among a select group of global medicine and device regulatory policy bodies that includes the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Pharmaceutical Regulators Forum (IPRF), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the International Medical Device Regulators Forum (IMDRF). This web of international regulatory aggregators is growing in influence when it comes to how medicine/device development and distribution are being regulated at the global, continent, and country levels in the name of harmonization, complexity management, and cost efficiency.

During the past several years, the ICMRA has strengthened its connective tissue. As a result, we’re beginning to see how the coalition is working across the world to help sponsors develop medical products in a more globally harmonized way moving forward:

Clinical trials now occur around the world and generate results that may be used for drug and device approvals in multiple countries. Sophisticated research techniques in biotechnology, gene editing, and cell-based therapies increasingly underlie more complex medicines entering the worldwide marketplace.

In addition, the active pharmaceutical ingredients (APIs) and genetic material used in clinical trials and in medicines are part of a complex global supply chain with varied patent and privacy rules in differing locales. The many manufacturing steps involved in producing a medicine or medical device may now be carried out in different countries or continents. The resulting medicines and/or medical devices are then being reviewed, approved, and distributed in multiple places around the world.

Add to this the increasingly interconnected world, where continents and populations are connected by hours via airplane rides or even seconds via the internet. Furthermore, unknown and known global health threats like Ebola and the Zika virus disease can travel and spread as fast, requiring global coordination and resources from all sectors.

International cooperation among medical product regulators has become key to supervising and managing all this, including the need for new regulatory rules and processes. Regulators are working to harmonize their efforts on a global scale like never before to get innovative, safe and effective medicines and devices on the market in a more timely, affordable manner. Understanding these new rules, and how they affect the clinical trial process, is key for sponsors, and we are committed to staying informed about the latest updates. For more information, contact our regulatory experts today.