Regulatory Blog

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

As medical technology advances, the FDA’s regulatory frameworks continue evolving to ensure timely, safe, and effective device...

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

In South Africa, the licensing of medical device establishments is a vital step to ensure compliance with national health regulations and...

As the healthcare industry continues to evolve, the integration of personalised medical devices and companion diagnostics has become...

Pharmacovigilance is critical for ensuring drug safety in the EU. EudraVigilance is the central system operated by the European Medicines...

The integration of real-world data (RWD) in clinical research is revolutionizing the pharmaceutical landscape. The Medicines and...

Understanding and navigating the UK's regulatory requirements is crucial for pharmaceutical companies aiming to obtain marketing...

Companies increasingly turn to co-marketing partnerships in today’s highly competitive pharmaceutical landscape to expand product reach,...

The European Medicines Agency (EMA) has long committed to this principle through Policy 0070, which governs the publication of clinical...

In a globally interconnected pharmaceutical landscape, regulatory collaboration is essential to ensure timely patient access to safe and...

In a regulatory landscape that continually evolves to ensure public health and safety, the UK Medicines and Healthcare products...

The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...

The field of pharmacovigilance (PV) —the science of detecting, assessing, understanding, and preventing adverse effects or any other...

In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...

The pharmaceutical industry continually evolves to adapt to new scientific discoveries and technological advancements. Good Manufacturing...

The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on " The Northern Ireland MHRA Authorised...

When navigating Switzerland's regulatory landscape for medicinal products, two key guidance documents from Swissmedic stand out for their...

Switzerland’s regulatory landscape for pharmaceuticals continues to evolve, balancing patient safety with market efficiency. Two pivotal...