Regulatory Blog

India has recently made significant advancements in its healthcare regulatory landscape by launching two new online portals " Adverse...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their comprehensive guidance " Clinical Trials for Medicines –...

Today (26 August, 2024) the Swissmedic released " guidance for the industry on the electronic exchange of ICSRs in E2B(R3) format...

The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...

The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...

The Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance on "Apply for the early access to medicines scheme...

The Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance on " Medicines Pipeline Data " on 13 August, 2024 to...

Last Thursday (08 August 2024) the U.S. Food and Drug Administration (FDA) released final guidance aimed at " Optimizing the Dosage of...

Swissmedic has issued detailed guidance on (01 August, 2024) on the "Packaging for Human Medicinal Products" to ensure their safety,...

Yesterday (02 August, 2024), the Food and Drug Administration (FDA) announced that the final guidance on M12 drug interactions was...

On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...

On July 25, 2024, the U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Center for...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research...

Yesterday (23 July, 2024) Swissmedic, the Swiss Agency for Therapeutic Products, has released updated guidance " Electronic exchange of...

On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...

Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...

The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...

The US Food and Drug Administration (USFDA) Center for Drug Evaluation and Research recently released updated guidelines "Pediatric...

Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...