Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Germany suspends 80 products linked to Indian CRO problems

This article was originally published in Scrip

Executive Summary

The German regulatory agency BfARM has suspended 80 generic products whose marketing authorizations relied on bioequivalence tests conducted by the Indian CRO GVK Biosciences. The company's procedures have been called into doubt following a GCP inspection earlier this year which suggested shortcuts had been taken with BE studies.

You may also be interested in...



EU Unveils Ambitions To ‘Future-Proof’ Entire Drug Regulatory Framework

Ambitious efforts to make the EU more resilient to future challenges, such as health threats, drug supply problems, scientific advances and growing medicine costs, have taken a step forward with the publication of a roadmap for a wide-ranging Pharmaceutical Strategy to be adopted by the European Commission later in the year.

Coronavirus Update: More Drugs Enter Trials, UK To Host Latest Vaccine Summit

In addition to our daily in-depth coverage of key events relating to the coronavirus, we’re bringing you a periodic round-up of other pandemic developments. This edition covers events at the national, European and global level. 

EU Health Program To Help Boost Post-Coronavirus Recovery

The EU’s massive economic stimulus package, Next Generation EU, includes a wide-ranging health program that aims to make health systems more resilient to future threats by supporting the development and manufacture of affordable new medicines and vaccines as well as measures to prevent drug shortages.

Topics

Related Companies

UsernamePublicRestriction

Register

PS073981

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel