Regulatory Blog

As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic , continues...

In an era of data-driven drug development, the European Medicines Agency (EMA) has launched a transformative regulatory framework : the...

Myelodysplastic syndromes (MDS) are a group of complex, clonal blood disorders that predominantly affect older adults and may progress to...

Aluminum contamination in parenteral nutrition (PN) has long posed a silent but serious risk—especially to vulnerable populations like...

In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines...

The U.S. Food and Drug Administration (FDA) has finalized its guidance document on " Conducting Remote Regulatory Assessments (RRAs) ,"...

In June 2025, the FDA released two impactful draft guidances that significantly affect medical device and combination product...

The International Council for Harmonisation (ICH) has taken a major step toward modernizing clinical trial designs with the release of the...

Clinical trials are the cornerstone of modern medicine, ensuring that new treatments are safe, effective, and suitable for public use....

The stability of drug substances and drug products is a cornerstone of pharmaceutical quality, ensuring that medicines remain safe,...

To modernize and harmonize the management of medicinal product information, the European Medicines Agency (EMA) is actively implementing...

In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency  are more crucial than ever. The FDA’s...

As the role of real-world data (RWD)  and real-world evidence (RWE)  grows in drug development, regulatory decision-making, and...

Navigating the regulatory landscape for medicines in the UK can be complex, especially as requirements evolve and innovation accelerates....

The Medicines and Healthcare products Regulatory Agency (MHRA) published a key update on 17 June 2025 , outlining revised requirements...

The U.S. Food and Drug Administration (FDA) has released an updated guidance " ANDAs: Pre-Submission Facility Correspondence Related to...

The integration of real-world data (RWD) into regulatory decision-making is transforming the landscape of pharmaceutical development and...

In recent years, GLP-1 receptor agonists have gained widespread attention for their dual role in type 2 diabetes management and weight...

In the evolving landscape of pharmaceutical manufacturing, Decentralised Manufacture  has emerged as a pivotal approach, especially in...

The South African Health Products Regulatory Authority (SAHPRA) has released the sixth version of its Biological Medicines Amendment...