Regulatory Blog

Digital health is no longer just an emerging trend—it is rapidly transforming healthcare delivery, patient engagement, and medical...

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...

Artificial Intelligence (AI) and Machine Learning (ML) are transforming healthcare globally, offering powerful tools for diagnosis,...

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 U.S. Food and Drug Administration (FDA) released a comprehensive guidance document titled “ Animal Studies for...

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On 18th August 2025, the U.S. Food and Drug Administration (FDA) recently published two important draft guidance documents that aim to...

Artificial Intelligence and Machine Learning (AI/ML) are increasingly used in medical devices—from diagnostic imaging software to digital...

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...

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has released a notice a...

The Medical Device Authority (MDA) of Malaysia has officially launched the Malaysia–China Medical Device Regulatory Reliance Programme ,...

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

On 8 August 2025,  the European Commission  released an in-depth study on the " Deployment of artificial intelligence (AI)  in healthcare...

On 8 August 2025 , the European Medicines Agency (EMA) published the latest revision (Rev. 14) of its "Procedural Advice on Paediatric...

The European Medicines Agency (EMA)  submitted its updated report to the European Commission (EC)  evaluating the feasibility of...

Medical devices, whether diagnostic, therapeutic, or assistive, undergo rigorous scrutiny before entering the UK market. One of the most...

The proliferation of Digital Mental Health Technologies (DMHTs) —ranging from self-help apps and online therapy services to artificial...