Ten Papers, One Commitment: Five Years of Regulatory Science
08 september 2026
Bringing a new medicine to market is as much a regulatory challenge as a scientific one. Understanding how agencies like the European Medicines Agency (EMA) actually evaluate evidence – not just what the guidelines say, but how decisions play out in practice – is where regulatory strategy is won or lost.
Since 2021, this is exactly the question that a group of researchers within Zwiers Regulatory Company – a ProductLife Group company – has been exploring. What started as an ambition to contribute original thinking to the regulatory science community has grown into a body of ten peer-reviewed publications, spanning three distinct areas of regulatory practice.
The first paper in the series was recognised by DIA in 2024 as its most downloaded publication – an early signal that the questions being addressed were the ones the industry needed answered.
Getting to patients faster: procedural timelines, expedited pathways and incentives
Three papers examine how long it actually takes new medicines – mainly oncology drugs – to move through development and regulatory review in the EU and US, and which expedited programmes genuinely shorten that time. One paper focused on the regulatory incentives and opportunities comparing the EU with the US.
1.”A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines”
Therapeutic Innovation & Regulatory Science, 2021
By M. Garsen, M. Steenhof & A. Zwiers
Analyses 96 EMA anticancer drug approvals between 2010 and 2019 and finds that accelerated assessment cut average procedure time nearly in half (from around 370 to 200–215 days), while small companies faced procedures roughly four months longer than medium and large ones – largely due to longer clock-stop periods.
Read here: https://az-regulatory.com/wp-content/uploads/2023/02/Garsen2021_Article_ADecadeOfMA.pdf
2.“A Detailed Analysis of Regulatory Review Time of Marketing Authorization Applications for New Anticancer Drugs in the United States and European Union”
Clinical and Translational Science, 2022
By F. Goncalves, E. Demirci & A. Zwiers
Compares FDA and EMA review times across 76 new anticancer drugs and finds the US median review (201 days) was over four months shorter than the EU’s (337 days) – a gap that narrowed sharply when at least one expedited programme was used, though referral to an advisory committee largely erased that advantage.
Read here: https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.13308
3.“The EMA as a Potential Driver of Competitiveness of Orphan Medicines in Europe: A Focus on Regulatory Incentives and Funding Opportunities”
Orphanet Journal of Rare Diseases, 2025
By M. A. Gomez-Ferreria, V. Garcia-Muñoz & A. Zwiers
Looks to the US as a reference point for the EU Pharmaceutical Legislation revision, examining FDA programmes such as the Priority Review Voucher and Orphan Drug Grants, and proposes how comparable incentives could strengthen EMA’s role in supporting orphan medicine development in Europe.
Read here: https://az-regulatory.com/wp-content/uploads/2026/04/The-EMA-as-potential-Driver.pdf
4.”Trends in Oncology Marketing Applications in the European Union: A Five-Year Systematic Review”
Frontiers in Pharmacology, January 2026
By R. Basto, S. Karaya & A. Zwiers
Reviews 60 oncology marketing applications from 2020 to 2025 and finds large companies held 72% of applications, blood cancers were the leading indication, and applications with scientific advice or accelerated assessment saw shorter procedure times than the roughly 348-day average.
Read here: https://az-regulatory.com/wp-content/uploads/2026/04/Trends-in-Oncology.pdf
Building the quality case: from design principles to proof of potency
Two papers dig into what actually sits inside the quality section of the dossier – from how consistently companies document their development risk strategy from the outset, to how convincingly they can prove that an advanced therapy does what it claims to do.
5.”Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the EU Between 2014 and 2019″
Therapeutic Innovation & Regulatory Science, 2021
By J. P. ter Horst, S. L. Turimella, F. Metsers & A. Zwiers
Reviews all 494 EU marketing authorisations granted between 2014 and 2019 and finds that, five years after the QbD approach was formally adopted by ICH, only 38% of full-dossier applications used it in full – a share that did not grow over the period, with adoption notably lower for biotechnology-derived products than for small molecules.
Read here: https://link.springer.com/epdf/10.1007/s43441-020-00254-9
6.“Advancing Potency Assay Development for Advanced Therapy Medicinal Products: A Comprehensive Approach and Regulatory Insights”
Human Gene Therapy, 2025
By A. Abdellatif, M. Bou Jaoudeh, A. Zwiers & G. Breda
Combines a literature review, industry input and a comparison of global regulatory frameworks – including FDA guidance on potency assurance – to propose a product-specific framework for designing potency assays across ATMP categories, and points to emerging tools such as droplet digital PCR as ways to improve precision.
Clinical development: what happens prior to submission and how does it impact the review process?
Three papers look at what happens upstream of submission – trial design choices, development duration, and the evidence gaps that surface once CHMP reviews the file – to understand how decisions made early in clinical development shape the outcome of the review itself.
7.”Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic Findings”
Therapeutic Innovation & Regulatory Science, 2022
By G. Omes-Smit, M. Garsen & A. Zwiers
Reviews 71 EU marketing applications for small-molecule anticancer drugs and finds 48 were studied in healthy volunteers – including 12 with a positive genotoxicity finding – where comprehensive follow-up toxicology testing showed no genotoxic risk to volunteers at the human exposure dose.
8.”Clinical Development Time of New Anticancer Drugs”
Clinical and Translational Science, 2023
By E. Demirci, G. Omes-Smit & A. Zwiers
Tracks clinical development time for the same 76 anticancer drugs and finds an average of 6.7 years overall – shorter for small molecules (5.8 years) than for biotech-derived products (7.7 years) – with specific combinations of expedited designations and accelerated or conditional approval routes cutting development time to as little as 4.5 years.
9.”Clinical Evidence Deficiencies Drive CHMP Negative Opinions and Pre-Opinion Withdrawals in the EU Centralised Procedure (2021–2025)”
Frontiers in Medicine, July 2026
By I. Pennings, P. Boruah & A. Zwiers
Analyses 47 marketing authorisation applications that failed CHMP review between 2021 and 2025 (16 refused, 31 withdrawn) and finds clinical concerns – chiefly study-design flaws and insufficient evidence of efficacy – present in 90–100% of cases, with withdrawn applications also carrying a broader mix of manufacturing and procedural issues, and procedural timelines consistently running well beyond EMA’s own benchmarks.
Read here: https://az-regulatory.com/wp-content/uploads/2026/07/fmed-13-1875064.pdf
10.‘’Translating Asian-Dominant Pivotal EvidenceInto EU Marketing Authorization: An EMA Regulatory Document Analysis, 2021–2025”
Clinical and Translational Science, 2026
By P. Boruah & A. Zwiers
The tenth and most recent paper opens a new line of inquiry: whether clinical evidence generated predominantly in Asia can support a successful EU marketing authorisation.
Read here: https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.70707
Why it matters
Ten publications across procedural timelines and incentives, quality dossiers, clinical development and cross-population evidence are, on their own, a research record. Taken together, they are something else: evidence that this network doesn’t just execute regulatory strategy – it studies how regulatory decisions are actually made, and shares what it learns.
There are more topics still to explore, and more papers to come.
For more information on any of the regulatory topics covered in these publications, get in touch with our regulatory affairs team.
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