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:
- Last October, just months after China officially joined the ICMRA, China’s General Office of the State Council announced guidelines that seek to reform clinical trial management in that country, including standardizing regulatory requirements and allowing for greater use of clinical trial data from other countries.
- In November, a mutual recognition agreement between the European Union and the United States became operational, thus allowing regulators in eight EU member states and the U.S. to rely on each other’s inspections of manufacturing sites of medicinal products. The EU member states are Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom. Previously, the FDA never recognized the authority of another country’s inspectorate, even though at least one manufacturing step takes place outside the EU for around 85 percent of the medicines sold in the union.
- The EU Medicines Agencies Network Strategy to 2020 is promoting reliance and work-sharing between regulators. It encourages the European Medicines Agency (EMA) and the other agencies in the EU network to share unredacted EU assessment and inspection reports with other regulators worldwide as much as possible.
- The EU council announced last November that the EMA was moving its headquarters from the UK to Amsterdam as a result of the country’s planned exit from the EU. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is a full member of ICMRA, separate from the EMA and EU Directorate General for Health and Consumers, which are also both members. It is expected that this regulatory relationship may help ease any regulatory standards confusion and setbacks created by the UK’s forthcoming exit from the EU.
- The ICMRA and the World Health Organization (WHO) have merged their regulatory training/capacity building databases [PDF] to support improved, more standardized regulatory training around the world.
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.