Regulatory Blog

The U.S. Food and Drug Administration (USFDA) has released two important guidance documents addressing the risks of sepsis and...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued several guidance documents detailing the licensing,...

The International Medical Device Regulators Forum (IMDRF) has released its final guidance document (IMDRF/AIML WG/N88:2025) outlining...

The South African Health Products Regulatory Authority (SAHPRA) has issued comprehensive guidelines to streamline the reporting of...

The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry on the process for the...

Malaysia’s Drug Registration Guidance Document (DRGD) is a cornerstone for pharmaceutical compliance. The " Drug Registration Guidance...

Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...

The European Medicines Agency (EMA) provided detailed revised guidance "Procedural Advice for Orphan Medicinal Product Designation " for...

On 15 January, the Medicines and Healthcare products Regulatory Agency (MHRA) released a suite of guidance outlining the new PMS...

On 21st January 2025, the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research issued final guidance "...

Swissmedic has published an updated guidance for" Orphan Drug " aimed at streamlining the regulatory process for medicinal products...

The World Health Organization (WHO) has released the draft working document titled " Points to Consider in Continuous Manufacturing of...

The Medicines and Healthcare Products Regulatory Agency (MHRA) published its comprehensive guidance titled “ Applying Human Factors and...

The U.S. Food and Drug Administration (FDA) released final guidance " Premarket Approval Application and Humanitarian Device Exemption...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S)  has released its " Guidance on Remote Assessments " effective from January...

On 07 January 2025, the U.S. Food and Drug Administration (FDA) released the draft guidance titled " Developing Drugs for Optical Imaging...

The U.S. Food and Drug Administration (FDA) has recently issued several key guidance documents addressing critical areas in...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “ Artificial Intelligence-Enabled Device Software...

The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...

Swissmedic, the Swiss Agency for Therapeutic Products, has recently updated its guidance documents for " Parallel Import " and "...