November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Device Regulation (EU IVDR).
 
US, China, and EU: Regulatory and strategic comparisons
China is working steadily to narrow the gap between in and the US in research and development spending and advancement of innovative therapies. In Comparison of pharmaceutical development drug regulatory pathways in the US and China, global regulatory strategist Angela N Mikroulis outlines and compares the health authorities, regulatory frameworks, and intellectual property environments of the two countries, discussing their differences and respective challenges and opportunities in the evolving global regulatory landscape. Mikroulis notes that despite its advances, China still needs to provide more clarity on its regulatory framework and implement stronger intellectual property laws to foster innovation.
 
Advanced therapies require additional regulatory and strategic considerations because of their novelty and complexity. The EU and US each has an extensive guidance for these therapies, but the differences between them need to be understood early on and factored into strategic development plans. In Advanced therapies: Navigation and application of EU and US guidelines during product development, regulatory intelligence expert Kirsten Messmer and global development solutions expert Richard Dennett present a comparative overview of the guidance, highlighting the main points of consideration for each. The authors also provide useful suggestions on navigating the large volume of information and applying the guidelines during product development.
 
FDA approvals and warning letters
Although it is preferable for a drug and its companion diagnostic (CDx) to be validated together in a Phase 3 trial and submitted simultaneously to the FDA for approval, that is seldom the case. Currently, the drug tends to be submitted earlier than the CDx, especially if efficacy is shown in a Phase 2 study and the drug has been granted accelerated approval. In Challenges to contemporaneous FDA approval for companion diagnostics and their drug partners, product development experts Kennon Daniels and Jo-Ann Fabila Gonzales, dissect the challenges sponsors face in coordinating the development and trial phases for drug-CDx products. The authors recommend numerous proactive regulatory steps that can help avoid having a CDx stall the marketing of the drug.
 
In FDA warning letters in 2020 reveal concerns around purity, investigations, and data integrity, quality and compliance expert Sarah B. Tanksley and regulatory intelligence and warning letter specialist Audrey Francis report on their review of 2020 FDA warning letters relating to good manufacturing practices (GMP). The authors examined the common citations in letters issued through 10 August 2020 and found they centered on drug purity, inadequate attention to unexplained discrepancies, and a range of data integrity failures. They recommend companies incorporate steps in the manufacturing process to check, verify, and gather data on product quality, and monitor data integrity at every level of manufacturing to maintain an audit of traceable information to support production of safe, high-quality products.
 
Gearing up for the IVDR
Effective, timely IVDR compliance takes time and commitment – from top to bottom, regardless of company size. In Getting ready for the IVDR transition, clinical compliance expert Gail Gasior draws on her experience as a director of clinical compliance at a US-based global manufacturer to describe the challenges and solutions to preparing currently marketed in vitro diagnostic (IVD) devices for new requirements under the EU IVDR, set for full implementation by 26 May 2022. The takeaway strategies are the regulatory stalwarts: effective communication, close collaboration, meticulous coordination of resources, and early and frequent engagement with the notified body.
 
What’s coming in December?
Articles during December will focus on Advertising, Promotion, Labeling and the Role of Social Media.
Articles will cover latest trends in regulatory advertising and promotion, including FDA guidance documents, enforcement trends, and how regulatory professionals can apply recent guidance and enforcement actions. Look for these topics and more throughout December in Regulatory Focus.
 
And January?
In January, the focus will be The Impact of Disruptions on the Global Regulatory Community. Articles will examine the impact of disruptions, especially COVID-19, on work style, remote/smart working, and communication. They will also cover working within your company vs. with external partiess; third-party reviews; developing the next generation of staff and finding new employment during the pandemic; the impact on global regulatory affairs; best practices for meeting remotely with health authorities; and comparison of onsite and virtual good manufacturing practices. Look out for articles on these topics throughout January in Regulatory Focus.
 
Call for Articles for February 2021
For February 2021, Regulatory Focus will look at Global Regulatory Harmonization. The submission deadline for articles is 13 January 2021. To contribute to the January issue or suggest a topic, contact Renée Matthews at rmatthews@raps.org.
 
Citation Matthews R. Regulatory Focus, November issue: The Regulatory Toolbox. Regulatory Focus. December 2020. Regulatory Affairs Professionals Society.<