Regulatory Blog

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...

On June 2, 2025 , Swissmedic published a harmonised suite of guidance documents to standardise, streamline, and digitalise the clinical...

In a major step toward global harmonisation of clinical trial processes, the U.S. Food and Drug Administration (FDA) and the...

Human normal immunoglobulin (IgG) products administered via the subcutaneous (SCIg) or intramuscular (IMIg) route are essential...

What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...

Developing drug products across multiple strengths is a common strategy in pharmaceutical formulation, allowing dose flexibility and...

A color additive is any dye, pigment, or substance that imparts color to a drug. Only color additives listed in FDA regulations are...