Regulatory Affairs
Regulatory data and market exclusivity: What will change with the new pharmaceutical regulation?
In this blog, we explore the current EU framework for regulatory data exclusivity and market exclusivity, examine the proposed legislative changes, and discuss what these reforms could mean for pharmaceutical and biotechnology […]
How will the revised pharmaceutical regulation change the Marketing Authorisation Application?
In this blog, we explore the current EU marketing authorisation framework, examine the proposed legislative changes affecting the MAA process, and discuss what these updates could mean for pharmaceutical and biotechnology companies […]
How will the revised pharmaceutical legislation change paediatric drug development?
In this blog, we explore the current EU paediatric medicine development framework, examine the proposed legislative changes, and discuss the potential impact on medicine developers who must include paediatric studies in their medicine development programmes and get […]
How will the revised pharmaceutical regulation change the EMA’s Priority Medicines (PRIME) scheme?
In this blog, we explore the current PRIME framework, examine how the revised pharmaceutical legislation may impact the scheme, and discuss what these changes could mean for medicine developers navigating the evolving EU regulatory […]
How will the revised pharmaceutical legislation change orphan-designated medicines for rare diseases?
In this blog, we explore the current EU orphan designation framework, examine the proposed legislative changes, and discuss the potential impact on medicine developers pursuing orphan medicinal product designation and approval in […]
What are the challenges with Project Optimus?
While the goals of Project Optimus have been widely welcomed, its implementation has also raised important questions for medicine developers, regulators and other stakeholders.
Project Optimus: Why does the oncology dosing paradigm need to change?
Introduction The emergence of targeted therapies, biologics and immunotherapies has transformed the oncology treatment landscape, raising important questions about whether traditional dose-finding approaches remain fit for purpose. Historically, oncology drug development has […]
What is Project Optimus, and what problem is it trying to solve in oncology dosing?
The Food and Drug Administration (FDA) launched Project Optimus, an initiative to establish a dose-optimisation paradigm for cancer therapies. The goal is to collaborate with medicine developers, academia and patients to develop […]
Regulatory Roundup: News & Publications in Pharma and Biotech in December 2025
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this roundup, you’ll find key publications that caught our attention, plus a curated […]
Regulatory Roundup: News & Publications in Pharma and Biotech in November 2025
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this roundup, you’ll find key publications that caught our attention, plus a curated […]