Regulatory Blog

Health Canada last week published an updated "Guidance on Nitrosamine Impurities in Medications" that details about on Evaluating and...

Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...

Last Week (20 April 2023) the European Medicines Agency updated and released the guidance on "IRIS guide to Registration and RPIs" which...

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (11 April, 2023) released an updated guideline on " Electronic...

Earlier today (17-April-2023) he Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Guide to Serious Adverse...

Today (12 April 2023) USFDA's Center for Drug Evaluation and Research released two draft guidances on"Assessing Adhesion With Transdermal...

Earlier today (12 April 2023) USFDA's Center for Drug Evaluation and Research released a draft guidance on"Over-the-Counter Monograph...

Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions...

The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical...

Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...

Today (o5 April 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft...

Statutory guidance on MHRA fees A new statutory fee for MHRA services was introduced on April 1, 2023, by the Medicines and Healthcare...

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance “System...

Today (31 March 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released updated...

Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...

Pakistan's Drug Regulatory Authority of Pakistan released Draft Guidelines for "Good Cold Chain Management Practices for...

Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...

Earlier today (24 March 2023) USFDA's Oncology Center of Excellence released a draft guidance on "Clinical Trial Considerations to...

Earlier today Switzerlands Swissmedic released an updated guidance document for "Requesting Product Certificates - Certificate of a...

Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...