Regulatory Focus, August issue: Global clinical trials, clinical trial applications

Feature ArticlesFeature Articles
| 01 September 2020 | By Renee Matthews  | ©

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.
Hamish King, a specialist in NMPA registration of medical device, notes that China-based clinical trials have become an increasingly viable option for global medical device and IVD companies following China’s ongoing efforts to align with international regulatory standards. In Initiating clinical trials in China: What foreign MedTech companies need to do, King addresses specific questions prospective applicants might have about conducting trials in China, such as which hospitals participate in clinical trials, how to determine of a clinical trial is exempted or mandatory, what notifications are required when initiating a China clinical trial, and which overseas clinical data NMPA will accept.
COVID-19: Clinical trials and EUAs
During the early stages of the COVID-19 pandemic, there was considerable concern about clinical trial continuity and the impact of disruption on patients, trial processes, and outcomes. In Interacting with competent authorities during COVID-19 – A European perspective, clinical trial expert Anna Baran and regulatory specialist Stephanie Geiger report on their findings regarding safety-related submissions and notifications to European authorities in response to the pandemic. They contacted selected authorities for data on submission events from 1 March to 30 June 2020. The authors found that after initial fall-off in trial submissions in the first 6-12 weeks of the pandemic, the number of trials submitted and reviewed over the second quarter of 2020 did not differ substantially from that in 2019. Baran and Geiger emphasize the importance of trial partners and authorities remaining connected so that they can exchange information on limitations, discuss solutions, and support guidelines that will allow studies to go live.
Canada is an appealing destination for the conduct of clinical trials. Its shorter approval timelines and broader submission requirements offer an appealing option for companies and research institutions wanting to invest clinical trial health research. In The Canadian application process and alternate pathway for COVID-19‒related clinical trials, regulatory specialists Mukesh Kumar and Melanie Oakley
offer an overview of the Canadian clinical trial application processes for biologics and pharmaceuticals and regulatory obligations under current guidelines. They share information on a range of clinical trial submission requirements, such as the application format, folder structure, and transmission of data. The authors also advise on how best to communicate Health Canada’s relevant directorates and offices.
Current FDA policy for emergency use authorizations (EUAs) does not address at-home test kits for COVID-19. In FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic, regulatory specialist Ashley Clark discusses the development and implementation of the EUA for  diagnostic devices in the US during the pandemics. Clark cautions this limited oversight might affect future requirements for demonstrable superiority claims after the EUAs are terminated and diagnostics for the virus undergo increased scrutiny by the agency for marketing authorization. She covers the implications for the diagnosis and treatment of COVID-19 associated with variations in state and federal oversight, the authorization of diagnostics as it has evolved since late 2019, and their potential impact on future regulation of such devices.
What’s coming in September?
Articles during September will focus on the implementation and acceptance of the EU Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR). Included in the line-up will be articles on why the IVD Directive is so different from the IVD Regulation, challenges in implementing the EU IVDR from a manufacturer’s perspective, and preparing for the IVDR transition. Look for these topics and more throughout September at
November Call for Articles
For November, Regulatory Focus will look at Policy changes – The International Council for Harmonisation, Pharmaceutical Inspection Co-operation Scheme, and regulating future policies. The submission deadline for articles is 1 October 2020. To contribute to the November issue or suggest a topic, contact Renée Matthews at
Citation Matthews R. Regulatory Focus, august issue: Global clinical trials, clinical trial applications. Regulatory Focus. July 2020. Regulatory Affairs Professionals Society.


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