Julie Warner, VP of Regulatory Affairs at Boyds, has co-edited the latest issue of TOPRA’s Regulatory Rapporteur. In this issue, Julie, along with Nancy Pire-Smerkanich from the School of Pharmacy at the University of Southern California, co-authored the article entitled ‘Winning the Regulatory Race Against Time’ which discusses the challenges facing regulatory professionals in their quest to keep on top of an ever-increasing workload to advance effective and safe products as quickly as possible.
The following article was published in the Regulatory Rapporteur, Volume 17, Number 11, November 2020.
Our world and the discipline of regulatory science is constantly changing. Never has this been more apparent than as we face this global pandemic and the regulatory response to it. While we would normally aim to offer a significant commentary on regulatory hot topics within our editorial, at the moment we are all very much aware of the challenge facing the global population in the current COVID-19 pandemic, and so many regulatory affairs professionals are fighting to keep on top of an ever-increasing workload to advance effective and safe products as quickly as possible.
Therefore, instead of telling you what you already know, it’s worthwhile taking a few moments here to share some of the US resources that may be helpful. Firstly, the US FDA has created a useful landing page for the Coronavirus Treatment Acceleration Program,1 which includes FDA blogs, what products are in development, how many trials the FDA has reviewed, what emergency use authorisations (EUAs) have been granted and links to resources for researchers and companies, along with information on the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, a critical initiative being coordinated by the Foundation for the National Institutes of Health (FNIH) with industry and government collaborators.
Two additional, and perhaps less well known, general resources are the Small Business Assistance webpage2 from which you can access sites for drugs, devices and other centres and regional offices. Although intended for regulated small businesses, the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) and the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) are particularly helpful. The SBIA webpage3 has a list of (free) events and a dropdown menu that covers a myriad of topics. You can also navigate from there to the Regulatory Education for Industry (REdI) conferences and webinars, all of which have downloadable slides and presentations. The DICE site4 has links to “Device Advice” and is home to CDRH Learn, which is similar in design and content to the SBIA.
As a backdrop, let’s not forget that the FDA is already undergoing a significant modernisation activity, as we see in an article summarising the steps the agency is taking to move towards more integrated, effective and patient-focused reviews and approvals. It’s often said that necessity is the mother of invention, so it will be interesting to see whether the current pandemic accelerates the development and roll-out of some of these new approaches to working. This theme runs in to our focus interview with two Director Generals at Health Canada on the activities undertaken by the agency to ensure it is ready for new technologies and platforms, such as cell and gene therapies via its regulatory renewal initiative, the Agile Regulations Project. With such product types often including many novel aspects that don’t always sit clearly in one category or another (eg, novel device, unique handling aspects), it’s refreshing to see close collaboration within the agency in this regard. Finally, we highlight the recognised need for cooperation at both the regional and global level for combination products in a report on the TOPRA-RAPS joint workshop, which efficiently summarises the different stance of the FDA versus that of the European Commission and European Medicines Agency.
Moving away from our US focus, we are also fortunate to have two valuable updates, firstly on the status of the medical devices standards, which includes the March 2020 EU harmonised standards. The second includes a “one-stop” source of information on early access programmes in the EU in a handy tabular format, as a follow-up to an article in September 2020. Finally, we have a thought-provoking read on the challenges faced in the development of a semi-automated tool for text mining for document curation and automatic regulatory submissions in the context of the identification of medicinal products (IDMP) standards. We would like to close out this editorial by encouraging everyone to maintain their reading and training during this difficult time (to perhaps avoid receiving penalties for non-compliance with FDA regulations, as highlighted in an article in this issue with regard to the clinicaltrials.gov database).
To view the November issue of Regulatory Rapporteur, click here.