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