Regulatory Blog

On 25 September 2025 , the U.S. Food and Drug Administration (FDA) highlighted four critical updated or reaffirmed guidances  spanning...

The UK’s Medicines and Healthcare products Regulatory Agency ( MHRA ) has issued a coordinated update to its suite of clinical trial...

On 22 September 2025 , the European Commission published new variations guidelines  in the Official Journal of the European Union. These...

On September 19, 2025, the U.S. Food and Drug Administration (FDA) released its revised draft guidance, “ Safety Labeling...

The U.S. Food and Drug Administration (FDA) released three important draft guidances  on September 11, 2025, providing updated...

The U.S. Food and Drug Administration (FDA) has released a new draft guidance " Development of Non-Opioid Analgesics for Chronic Pain "...

The U.S. Food and Drug Administration (FDA) has issued a final guidance on 11th September 2025 titled “ Alternative Tools: Assessing Drug...

Last week, two pivotal updates were introduced: the Union Health Ministry proposed major amendments to the New Drugs and Clinical Trials...

In 08 September 2025, the U.S. Food and Drug Administration (FDA) issued two final guidances addressing critical aspects of biosimilar...

On 1 September 2025 , Swissmedic published a set of updated guidance documents that refine requirements for medicinal product...

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in regulating medicines, medical devices, and related...

On 26th August, 2025 the South African Health Products Regulatory Authority (SAHPRA) has introduced a structured framework for the...

Good Manufacturing Practice (GMP) serves as the backbone of pharmaceutical quality assurance. It ensures that medicinal products are...

Clinical trials are the cornerstone of developing safe and effective medicines. In Switzerland, the regulatory authority...

On 18 August 2025, Swissmedic published Version 2.3 of its guidance on the " Submission Process for Clinical Trials with Medicinal...

On 22 August 2025 , the Medicines and Healthcare products Regulatory Agency (MHRA) published an updated version of its guidance “...

On 18th August 2025, the U.S. Food and Drug Administration (FDA) recently published two important draft guidance documents that aim to...

In the pharmaceutical lifecycle, there are times when a marketing authorisation holder (MAH) needs to cancel a medicine’s marketing...

On 1 August 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has...

In 1st & 8th August 2025, the European Medicines Agency (EMA) announced two major milestones in the transition to electronic Common...