RAPS’ new International Fundamentals book includes pandemic-related updates, and a lot more
There is no question the COVID-19 pandemic has stressed healthcare systems around the world, forced manufacturers and regulators alike to rapidly shift both priorities and processes, and created a broad range of new challenges. It remains to be seen what long-term changes will result from the crisis, but regulatory professionals are already dealing with some of the effects.RAPS’ recently released Fundamentals of International Regulatory Affairs, Fifth Edition, was developed in the midst of the global crisis and touches on a number of relevant pandemic-related topics. Although the impacts of the pandemic on regulatory do not account for a large part of the book’s comprehensive coverage of global regulatory affairs, and some changes may not be fundamental in nature, they are relevant nonetheless and underscore the importance of staying up to date with regulatory developments.
As RAPS Editorial Advisory Committee Chair Daniel G. Mannix, PhD, wrote in the book’s foreword, “There is no doubt that the COVID-19 pandemic has had an impact on how products are developed and registered, and how regulators maintain oversight over industry.”
Some of the most readily apparent areas affected by the pandemic that are covered in the new International Fundamentals include vaccine development, the sudden demand for new treatments, and crisis response by global regulators like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Also discussed are the roles of international organizations like the World Health Organization (WHO), the International Coalition of Medicines Regulatory Authorities (ICMRA) and the International Council on Harmonisation (ICH) in such a global crisis.
The new reality of quarantines and travel restrictions required new ways of conducting business and regulatory oversight. Inspections that were almost exclusively conducted on site prior to the pandemic had to shift to remote inspections. Impacts on the global supply chain had to be taken into account as supply chain disruptions can result in drug shortages and affect pricing and reimbursement.
The demand for previously non-existent treatments and diagnostics means that regulators, in addition to prioritizing review of new products to help stem the crisis, also must be on the lookout for false advertising and bogus products aimed at anxious consumers.
The regulatory environment is constantly changing as a result of numerous and complex forces. The COVID-19 pandemic raised new challenges, but also affected existing trends. Some questions will take time to answer, such as will the crisis-necessitated cooperation among global health organizations and regulators accelerate regulatory harmonization efforts? And will processes that were changed by necessity lead to more enduring regulatory changes or other innovations?
A clear lesson of the COVID-19 pandemic is the importance of crisis preparation. Since crises can happen without warning and escalate rapidly, one of the most critical steps a regulatory professional can take is to continuously build trust and a solid reputation with regulators.
Fundamentals of International Regulatory Affairs, Fifth Edition, is up to date through May 2021 and its content takes into consideration numerous regulatory and technological changes that have occurred over the last three years, of which pandemic-related impacts are only part. The book is a comprehensive reference for professionals at all levels working in multinational product development and marketing.
Fundamentals of International Regulatory Affairs, Fifth Edition, is available in print and e-book versions for $295.00 for RAPS members, and $395.00 for nonmembers.