Regulatory Blog

On 18th August 2025, the U.S. Food and Drug Administration (FDA) recently published two important draft guidance documents that aim to...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 U.S. Food and Drug Administration (FDA) has announced On 30 July 2025 , the official user fee rates across its major healthcare...

On 30 July 2025, the U.S. Food and Drug Administration (FDA) officially published the Biosimilar User Fee Rates for Fiscal Year (FY) 2026...

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

In July 2025, the USFDA published a revised guidance titled " Medical Device User Fee Small Business Qualification and Determination "...

On 25 July 2025 , the European Medicines Agency (EMA) published the latest guidance " Procedural Advice on Paediatric Applications " ....

In May 2025, the FDA, as part of the International Council for Harmonisation (ICH), endorsed and released for consultation the draft E21...

The European Medicines Agency (EMA) continuously updates its Good Pharmacovigilance Practices (GVP) guidelines to enhance patient privacy...

On 24 July 2025 , the UK Government published the latest update to its official guidance: " Regulation of medical devices in Northern...

On 22nd July 2025, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released the Third Edition, Tenth Revision of the " Drug...