Feature articles during August focused on global clinical trials and clinical trial applications, with articles on regulatory options for conducting clinical trials in China, a case study on the impact of COVID-19 on submissions to European authorities, and an examination of Canada’s application process and alternate pathway for COVID-19‒related trials. Also included was an article on US Food and Drug Administration (FDA) updates on requirement for EUAs for diagnostics supporting the pandemic.
Despite international efforts to produce guidelines for developing drugs and biologics and to standardize the format of marketing applications, there are still considerable differences among countries in the format of clinical trial applications and health authority review processes. The articles in this issue, focusing on China, Canada, and the European Union, examine those divergent formats and processes and provide options for, and advice on, navigating the regulatory complexity and fluidity of clinical trials. The takeaways from each of the articles are the same – applicants need to do their regulatory homework, plan carefully, and be on constant lookout for guideline updates and revisions before they submit their applications. Doing that can help save time, money, and resources, warns one author.
Clinical pathways in China
In Current Chinese NMPA clinical pathways for medical device registration, Grace Fu Palma, an expert in Chinese regulatory and clinical affairs strategy, and coauthors Jason Zhang, Xiaolian Zou, and Beibei Xing, present the key highlights of the current clinical pathways for registering medical devices in China in accordance with the country’s National Medical Products Administration (NMPA) regulations and guidances. The general direction is toward international harmonization and increasing the overall quality, safety, and efficacy of approved devices. The authors advise on various settings in which the clinical pathways should be used and reiterate the importance of understanding the most current guidelines before submitting an application…