Search Results for competent authorities

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German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies By Zachary Brennan - Published 10 August 2017

Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories.

Categories: News, Asia, Europe, EC, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Dr. Reddy's, competent authorities, EudraGMDP

The Essential List of European Pharmaceutical and Device Regulatory Authorities By Michael Mezher - Published 20 February 2015

It can be difficult to keep track of regulators on a global scale. To make finding the relevant websites for the various regulatory authorities and ministries of health around the world a little easier, Focus will be building resources for major regions.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Tracker, Websites of European Regulators, EU Regulatory Websites, EU Regulators, EU Pharmaceutical Regulators, EU Medical Device Regulators, Competent Authorities

EMA Releases Updated Final Guideline on Active Substance Master Files By Alexander Gaffney - Published 13 July 2012

Categories: EMA

Tags: National Competent Authorities, CDT, EDMF, MAV, ASMF, MA, Sponsor, application, Latest News, MAH