Regulatory/GMP Compliance, Europe

MHRA Signs MoU with Russian Counterpart for Regulatory Cooperation on Medicines

February 01, 2019

A Memorandum of Understanding (MoU) has been signed by the UK’s MHRA and the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.

EMA Implements the Next Phase in its Relocation Plan

January 25, 2019

The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.

Wasdell Group’s New EU HQ Receives HPRA License

January 25, 2019

The Wasdell Group has been granted a Health Products Regulatory Authority (HPRA) license for its new European headquarters, based in Dundalk, Ireland.

Looking Beyond the Deadline

January 18, 2019

The EU FMD deadline is closing in, so now is the time to look beyond the short term.

EMA Publishes Draft Guidance on Antibiotic Development

January 14, 2019

The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.

EMA Authorized 84 Drugs in 2018

January 04, 2019

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

Global Inspection Harmonization

January 02, 2019

Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.

Regulatory Divergence: The Burden of Brexit?

January 02, 2019

As Brexit rapidly approaches, the lack of clarity around the regulatory balance between the regions could lead to a reduction in standards.

A Year of Possible Regulatory Upheaval and Paralysis

January 01, 2019

This coming year could see a combination of regulatory uncertainty and inactivity for the pharma industry, mainly as a result of Brexit.

Sanofi’s Dengue Vaccine Receives European Approval

December 20, 2018

Sanofi has been granted marketing authorization by the European Commission for its dengue vaccine, Dengvaxia, following the earlier recommendation of approval by the EMA's CHMP