Regulatory Blog

Earlier today (17 May 2023) the European Medicines Agency released an updated guidance document on "Good Practices for Industry for the...

This week (11 & 12 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...

Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated "Guidance on the qualified...

Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...

Irelands Health Products Regulatory Authority (HPRA) released final guidance on "Reporting and Investigation of Quality Defects in...

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing...

Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...

This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...

Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics...

Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...

Recently this week (25 April, 20223) the European Medicines Agency updated and released the guidances on "Pre-authorisation procedural...

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Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...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

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...