Great news for Industry – MHRA lowers demands on safety requirements

Great news for Industry – MHRA lowers demands on safety requirements

Great news for Industry – MHRA lowers demands on safety requirements

 

Until now the MHRA, the regulatory body of UK was demanding pharmaceutical companies submit drug safety surveillance reports on a regular basis. They would then use these reports to create a risk-based report of their own, which would be used to prioritise inspections.

In a recent declaration, the MHRA has announce that they no longer require these reports:

“As of 2016, we no longer require routine compliance reports to be submitted as we now have access to a variety of information sources that can support our scheduling and planning activities.”

For more information please click HERE.

http://www.raps.org/Regulatory-Focus/News/2016/07/26/25395/MHRA-Drops-Pharmacovigilance-Compliance-Reporting-Requirements/