Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Mar 202 min read

UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device

This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...

Feb 72 min read

USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"

Yesterday (06 February 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...

Jan 21 min read

India CDSCO: Launching of National Single Window System (NSWS) Portal

To address the challenges in the management of medical devices, India's Central Drugs Standard Control Organization (CDSCO) has...

Nov 19, 20232 min read

USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model

USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidances related...

Jul 4, 20232 min read

EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol

Today (04 July 2023) the European Medicines Agency released a scientific guideline "Guideline for the notification of serious breaches of...