Medical and Regulatory Affairs

Current Challenges (and Solutions) in Global Regulatory Harmonization

According to a Council of Foreign Relations report, ensuring a safe and secure healthcare marketplace that can provide innovative therapies is no longer an undertaking for a single nation. The report concludes there is no way a single government regulator, including the gold-standard U.S. Food and Drug Administration (FDA), can support innovation and regulate products developed in labs around the world and destined for individual markets from roughly 300,000 manufacturing facilities located in more than 150 countries. No other national health or medicines regulatory agency has the capacity, either.

A decade-old study by the Centre for International Public Health Policy at the University of Edinburgh noted that the global regulatory harmonization movement of medicinal products is almost 40 years old. However, until the creation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 1990, larger harmonization agreement efforts, even with intervention by the World Health Organization (WHO), ended many times when country regulators bickered over who had the power to develop the standards and whose standards should be followed.

A more recent multi-year analysis [PDF] and mapping of key initiatives of multiregional, regional, and thematic medical product regulators and non-governmental organizations (NGOs) by the International Coalition of Medicines Regulatory Authorities (ICMRA) found there was no multilateral strategic coordination of regulatory efforts in vital areas including pharmacovigilance, supply-chain integrity, and international health crisis management. The ICMRA, ICH, and other affiliated harmonization groups are acting to correct this.

Fragmented standards and regulations across countries and regions are more easily manipulated by less scrupulous healthcare product participants or those looking to country hop in search of weaker regulatory entry points. Cross-border harmonization can help manage this and at the same time open multiple medical product markets at once. More uniform quality and safety standards across global markets can benefit industry participants by increasing product/industry trust, Good Manufacturing Practices (GMP), and enforceable cross-border intellectual property rights.

Since its inception 28 years ago, the main mission of the ICH has been developing and implementing harmonized guidelines and standards for drug development and registration. This long-standing mission has placed the ICH in the position today as the leading global operational and standards body.

The much younger ICMRA is more focused on global strategy and coordination, largely because its members are the top health and medicine regulators in the world’s most developed nations and regions. Both of these organizations are set up to coordinate their efforts with the WHO and dozens of international, regional, country, and technical-level regulators and associations like the Pharmaceutical Inspection Co-operation Scheme (PIC/S); the WHO-affiliated Pan-American Network for Drug Regulatory Harmonization (PANDRH);  the Council for International Organization of Medical Sciences (CIOMS), which largely is focused on biomedical products; and the Health Level Seven International (HL7), which sets standards for the exchange, integration, sharing, and retrieval of electronic health information.

For many years, the regulatory agencies and pharmaceutical industry associations of the European Union, the U.S., Switzerland, and Japan were largely the only nations signed on to global regulatory cooperation and harmonization efforts. No longer. In June 2017, a giant gap began to close when the China Food and Drug Administration (CFDA) joined the expanding ICH. China’s CFDA already is a member of the ICMRA along with health/medicine regulators from 18 other developed nations and the European Commission’s Directorate General for Health and Consumers and the EMA. India remains the largest medicine and medical device producing nation not participating in global regulatory harmonization efforts. Efforts continue to bring that country into the fold as well.

With each passing day, the once-isolated exclusive club of medicine and device overseers – once only open to Western Europeans, Americans and the Japanese – is letting in more global participants. A half-decade after global medicine regulators met in Geneva to find a better way to work together, their vision is being transformed into real action and collaboration that is improving therapy innovation, advancing public health, and better protecting patient safety worldwide. For assistance navigating this new regulatory landscape in your next clinical trial, contact Premier Research today.