Blog & Article
- 20th November 2025
Journal Articles
Journal Article
As companies seek ways to bring their products to multiple markets, understanding those markets and their regulatory approval process is imperative. Choosing the most appropriate pathway can reduce the burden on both the sponsor and on the health authorities, and potentially expand access to more patients.
Journal Article
It is widely accepted that biosimilars hold the potential to improve patient access to life-changing therapies. However, questions remain about what will be needed to deliver on the promise of greater biosimilar access and affordability.
Journal Article
A panel of industry experts share their insights on where the biosimilar industry is headed and how health authorities can support and influence efficient biosimilar development methods. With more biologics set to lose exclusivity, more competition from biosimilars could lead to a greater number of life-changing treatments at a lower cost, benefiting patients and healthcare systems.
Journal Article
Time is fast running out for transition of ongoing clinical trials in the EU to the Clinical Trial Regulation and submission through the Clinical Trial Information System (CTIS). The article will explore the challenges and implications for clinical trials that have yet to transition to the CTR. It will delve into key steps and strategic planning to manage the transition and address amendments to existing trials.
Journal Article
Health authorities are turning to digitalization to streamline their processes in response to global crises (such as the COVID-19 pandemic) that have affected the supply chain. The growing complexity of information and data in regulatory submissions has encouraged health authorities to implement structured data submissions and centralized e-submission processes through shared workspaces (1, 2). Some ongoing initiatives seek to simplify review and assessment processes through increased global cooperation and harmonization.
Journal Article
Check the different validation models in our industry and the specific models to follow.
Journal Article
In the two decades since biosimilars emerged on the world stage, their evolution has brought acceptance of the critical role they can play in making life-changing therapies more affordable.
Journal Article
The steps involved in manufacturing pharmaceutical products require rigorous processes to ensure the safety of patients. One important such process is cleaning validation — a critical element in current good manufacturing practice (CGMP).
Journal Article
There has been a continuous flow of new guidance documents and updates since the Clinical Trials Regulation (CTR) and accordingly adapted European Union Member State (MS) law became applicable on January 31, 2022. New information is communicated through different channels by the European…
Journal Article
Leadership is often thought of as driving productivity and business growth. For many years, leadership has been focused on results, earnings and being competitive. For me, however, a primary characteristic of leadership is authenticity.
Journal Article
The COVID-19 pandemic exposed significant challenges in the pharmaceutical global supply chain, leading to severe shortages of drugs and vaccines worldwide. This resulted in a pronounced inequity in distribution, particularly disadvantaging the Global South. This disparity is largely due to the dependency of low- and middle-income countries (LMICs) on pharmaceutical manufacturing in more industrialized nations. To mitigate this inequity and ensure supply of medicinal products across the globe, manufacturing of medicinal products needs to be decentralized through the establishment of manufacturing sites in LMICs.
Journal Article
Londa Ritchey’s expertise in quality operations, oversight, and management has been integral to PharmaLex’s success. Leveraging her strong background in microbiology and biostatistics, she effectively manages operational plants, supervises global manufacturers, and navigates complex challenges, ensuring the highest standards in the pharmaceutical sector. In an interview with Pharma Tech Outlook Europe, Londa shared her positive outlook on emerging pharmaceutical manufacturing trends and the promising uptake of rapid micro methods, enabling swift responses to challenges.