Journal of Regulatory Affairs, January-February 2026
Welcome to the Journal of Regulatory Affairs, a new title in the RAPS publications canon. This member-exclusive, bimonthly journal builds on the success of its predecessor, RF Quarterly, and continues to feature research-based, peer-reviewed content on emerging issues in global healthcare regulation, while introducing some shifts in the range and scope of coverage.There is also a renewed commitment to expand global and regional coverage of the regulatory space to better reflect both the international reach of regulatory practice and the composition of the RAPS membership.
Among the shifts is a completely new publishing opportunity for students who have successfully defended a graduate dissertation or thesis or an undergraduate capstone project. Students now have the opportunity to consider publishing that work, in full or as an article based on it. In addition, we will be publishing articles adapted from both Convergence and Euro Convergence presentations. (Convergence presentation articles have been published annually since 2022, but the extension to Euro Convergence presentations is new.)
The journal will continue to publish theme-focused articles based on the 2026 Editorial Calendar, while also including ad hoc articles on topics of author interest or specialty not on the calendar. This approach creates more publishing opportunities for prospective authors, hopefully resulting in a broader range of topics that more closely reflect the daily work of readers.
Fittingly, this new chapter begins during a milestone year for RAPS – our 50th anniversary. For most of that time, the society has produced publications of quality and standing in the community, beginning with Regulatory Affairs, a journal launched in 1989, to Focus Magazine, then Regulatory Focus, the RF Article Series, and, most recently, RF Quarterly. The Journal of Regulatory Affairs continues this tradition, providing evidence-based content that is original to RAPS, written by international regulatory professionals and experts, for regulatory professionals, and validated through a rigorous, double-blind peer-review process. Readers should note that Regulatory Focus will continue publishing as a standalone, independent daily news source for global healthcare regulators.
The journal aligns closely with the overarching RAPS mission by proactively addressing current global regulatory issues and trends and keeping regulatory professionals informed by providing valuable and accessible information for use as guidance or a resource in their daily regulatory work. In doing so, it provides authors with the opportunity to share their knowledge and expertise with their global regulatory peers, expanding the existing regulatory literature and supporting the continued growth and stability of the profession.
Numerous groups and individuals have contributed to making this launch possible. I thank the RAPS Editorial Advisory Committee (EAC) and the Journal Advisory Committee – comprising Daniela Drago, RAPS board member; Daniel Mannix, chair of the EAC; and Kim Young, regional engagement director at RAPS – for their guidance and support. I also thank Denise Fulton, RAPS vice president of research and content strategy; Anna Han, content editor; as well as RAPS colleagues across every department and function. In particular, I thank the authors, as always, for sharing their real-world knowledge and expertise with the RAPS community and invite readers to consider participating in this new journal venture.
In this issue
PCCPs, procedure packs, and pathwaysPredetermined change control plans (PCCPs) have transformed and streamlined in medical device regulation in recent decades, write Yu Zhao and colleagues in Understanding PCCPs: Lessons for postmarket innovation and global alignment. The authors provide an in-depth examination of the development of a PCCP framework in the US, from concept to implementation. They analyze key elements of two recent US Food and Drug Administration (FDA) guidance documents on PCCPs for artificial intelligence-enabled device software functions and for all medical devices. The article further explores best practices for drafting and maintaining PCCPs across the total product lifecycle and considers their strategic implications for manufacturers and regulators, as well as the potential use of the framework as a global standard.
In Navigating regulatory requirements for procedure packs and kits: An overview of US and EU frameworks, Anuja Yardi lays out a comparative analysis of the regulatory requirements for convenience kits and procedure packs in the US and EU, with an emphasis on classification criteria, labeling and unique device identifier (UDI) requirements, and registration obligations. Yardi examines the regulatory framework for convenience kits in the US and compares it with the applicable requirements under the EU Medical Devices Regulation (EU MDR) and related guidance documents from the Medical Device Coordination Group. She also offers practical insights into navigating both markets, emphasizing the importance of a comprehensive understanding of these regulatory considerations for compliant market entry and optimized global distribution strategies.
The FDA recently introduced an incremental new drug application pathway that took effect in May 2025. The additional condition for nonprescription use (ACNU) pathway has important potential benefits for branded prescription medicines, generic manufacturers, consumer healthcare companies, and most importantly, consumers and patients, note Paul Wardle and Aleks Lyons in Transforming medication access: A novel regulatory pathway for increasing direct-to-consumer access. They describe how technology can be leveraged to expand direct-to-consumer access to medications under the new pathway, the appropriate use of the ACNU, the considerations for developing an ACNU solution and the accompanying regulatory requirements, and the role of nonprescription labeling.
China, Spain, and the EU and US: A global scan
In CMC for cellular and gene therapies: A comparison of EU and US regulations, Rajiv Gangurde, David Murray, and Christiane Niederlaender explore the similarities and differences between the FDA and European Medicines Agency (EMA) in regulating raw and starting materials, process validation approaches, comparability requirements, and considerations involving medical device compatibility for cellular and gene therapy (CGT) development. They emphasize that an understanding of the nuances of global regulatory guidelines and requirements for chemistry, manufacturing, and controls is vital for developing CGTs, especially when targeting both markets.
The 2025 edition of the Chinese Pharmacopoeia (CPh) of the People's Republic of China includes systematic revisions and improvements across a range of entries as part of the Chinese Pharmacopoeia Commission’s key aim to continually harmonize the ChP with other international pharmacopoeias. In The 2025 Chinese Pharmacopoeia – Toward global harmonization, Yingying Liu and Zhihua Yue examine that approach describing the example of human plasma used to produce blood products and include comparisons with the US Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.).
In EMA centralized marketing authorizations in Spain, Mariona Florez Canals looks at the country-specific requirements that must still be met after the EMA has authorized marketing for a medicinal product in the EU. Florez Canals addresses the key regulatory requirements for registering and maintaining EU-authorized medicines in Spain, starting with the registration steps and marketing authorization holder responsibilities and including labeling, pharmacovigilance, anticounterfeiting measures, pricing and reimbursement, and requirements for promotional materials. The article provides practical insights into navigating the Spanish regulatory landscape within the broader EU framework, serving as a comprehensive guide for regulatory professionals.
Clinical trials and representative enrollment
Despite recent US statutory and guidance efforts to facilitate representative enrollment, the need remains for clinical trial participants to more fully reflect the broader US population. In Enhancing representation in clinical trials: From principle to practice, Junyang Wang and colleagues outline a framework suitable for regulatory planning and documentation. It focuses on the scientific rationale and regulatory expectations that link representation to inference; the operational levers – including protocol pragmatism and site and region selection strategy – that influence who can enroll; appropriate uses and limitations of enabling technologies, including artificial intelligence; the role of real‑world evidence and pharmacovigilance; and approaches for maintaining momentum despite changing policies.
Citation Matthews R. Introduction: Journal of Regulatory Affairs: January-February 2026; Volume 1, Number 1. RAPS Journal of Regulatory Affairs. 2026;1(1):1-3. Published online 12 January 2026.
https://www.raps.org/news-and-articles/News-Articles/2026/1/Journal-of-Regulatory-Affairs,-January-2026-Volume
Upcoming issue themes in the Journal of Regulatory Affairs in 2026
- Mar ‒ Apr The business of running an RA department
- May ‒ Jun Focus on global regulatory agencies & authorities
- Jul ‒ Aug Drug and device filings: A global perspective
- Sep ‒ Oct FDA policy and practice: 18 months on
- Nov ‒ Dec Global clinical trials
- Also see 2026 Editorial Calendar
Past issues and articles
- RF Quarterly articles (2021-2025)
- Regulatory Focus monthly articles (2018-2025)
- RF Quarterly 2025 RAPS Convergence (December 2025; includes all past full issue PDFs)
For authors A guide for submitting articles • Style guidelines for authors
Contact Renée Matthews, Managing Editor, and Anna Han, Content Editor, at [email protected]
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