August’s Regulatory Focus: Alternative regulatory pathways

Feature ArticlesFeature Articles | 03 September 2021 | Citation

Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Japan. Also included was an overview of recent US Food and Drug Administration (FDA) actions on materials in medical devices.
Global pathways
Daniel F. Simpson’s article, Emergency use authorizations for IVDs: Building on lessons learned, coincides with reports earlier this month of the FDA’s full approval of Pfizer’s Comirnaty mRNA vaccine for COVID-19, which had been granted an EUA last December. Simpson describes FDA policy on IVD EUAs, with a focus on recent diagnostic EUAs in response to the COVID-19 pandemic and examines how current policy has evolved compared with previous emergencies. He also considers how the lessons learned from current regulatory and clinical experiences with COVID-19 diagnostics could inform responses to future emergencies.
In The changing regulatory landscape for laboratory developed tests, Sarah A. Robinson, Alison R. Carter, and David A. Brindley describe LDT regulations in the US, especially in the context of the pandemic. LDTs do not typically require premarket review. The FDA has been unsuccessful in its attempts to introduce more rigorous regulatory frameworks, mainly because of concerns about the impact on test availability and innovation. Robinson and her colleagues assert that the potential risk of harm to patients from unreliable and inaccurate tests will increase as diagnostic tests become more complex and their use more common place. They suggest greater oversight through new legislation and regulation or updates to the Clinical Laboratory Improvement Amendments program may be needed to protect public safety.
Companies with medicinal products earmarked for placement on the Swiss market must file a national marketing authorization application (MAA) for approval in Switzerland because it is not an EU or European Economic Area member state. In Regulatory pathways for innovative medicinal products for Switzerland, Anja Bührer, David Berner, and Shayesteh Fürst-Ladani provide an overview of the relevant Swiss marketing authorization procedure pathways for medicinal products with new active substances. Although Swiss legislation tracks EU regulation in many areas, there Swiss-specific requirements, procedures, and timelines that can delay the filing of an MAA if not properly addressed in the initial application. The authors provide details of the expedited and simplified procedures, such as fast track, temporary authorization, and prior notification, and describe the work-sharing initiatives, such as the Access Consortium and Project Orbis.
In The SaMD regulatory landscape in the US and Europe, Vatsal Chhaya and Kapil Khambholja
examine the regulatory options for SaMD in Europe and the US, where the FDA recently updated its position statement on artificial intelligence‒ and machine learning‒based (AI-ML‒based) SaMD. Against that background, the authors offer takeaways on risk management associated with the use of SaMD, global regulatory alternative pathways for approving AI-ML‒based SaMD and the use of real-world data and evidence in pre- and postmarketing regulatory decision making. They also note the importance of having a system or regulation for identifying the challenges and ensuring safe, sustainable, and secure AI as the scope for AI-ML‒based SaMD expands.
Japan has recently enacted various regulatory reforms for cell and gene therapies, or regenerative medicines, to accelerate the development and approval of medicines for unmet medical needs. In Regulation of cell and gene therapy products in Japan, Tomoki Yokoyama reviews the history of regenerative medicines in Japan and describes current guidances and cornerstone legislation, including the Safety of Regenerative Medicine Act, the Pharmaceutical and Medical Devices Act, and the Cartagena Act, which governs biosafety. He also provides hands-on information about obtaining a manufacturing license for specific cell processing products, applying for approval of those products, quality and safety, and nonclinical tests and clinical trials for cell therapy.
Medical implants and metal contamination
There has been considerable focus in recent years on the materials in medical implants and their possible contribution to adverse outcomes. In An overview of recent FDA activity on materials in medical devices, Mary E. Gately, Brian J. Young, and Christopher G. Campbell examine the FDA’s attention on the medical device industry, and particularly on materials used in medical implants. The agency has held advisory committee meetings on certain types of medical implants and reported associated adverse events and on potential immunological responses to metal-containing implants. It has also issued recent guidance on the type of testing needed to support the approval of medical devices containing nitinol. Discussions at a recent advisory committee meetings on metal implants suggest there is no single solution to the issues, but Gately and colleagues note the FDA’s commitment to a greater focus on transparency and closer monitoring of new scientific developments relating to immune responses to medical implants.
Upcoming in Regulatory Focus
What’s coming in September?
Articles during September will examine Diversity in Regulatory Affairs. Look for this topic and more throughout September at Regulatory Focus.
And October?
For the October issue, Regulatory Focus will examine Vaccines, Advanced Therapies, and Biologics. The submission due date for articles has been extended to 30 September 2021. To contribute, email
Call for articles
November issue
In November, Regulatory Focus will cover Global development for pediatric products. The submission due date for articles is 1 October 2021. To contribute, email
Upcoming in RF Quarterly
Regulatory Focus launched the inaugural issue of RF Quarterly in mid-March. Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit. The summer issue, focusing on artificial intelligence, is now available. Themes for the rest of 2021 will be:
  • Quality and Compliance in Regulatory Affairs (September)
  • RAPS 2021 Convergence (December)
For questions regarding RF Quarterly, email
For more information, see Guidelines for Authors and the 2021 Editorial Calendar.

Citation Matthews R. August’s Regulatory Focus: Alternative regulatory pathways. Regulatory Focus. Published online 3 September 2021.


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