Regulatory/GMP Compliance, Europe

Detecting Apparent Total Nitrosamine Content in Pharmaceutical Drugs

August 02, 2022

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

New Guidance on the Use of Real-World Evidence

August 02, 2022

Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.

EMA Endorses Statement on International Collaboration of Real-World Evidence

July 25, 2022

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.

The European Union’s New Pharmaceutical Strategy for Europe

July 02, 2022

A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.

MHRA Updates Guidance on Handling of Approved or Pending DCP and MRP

June 27, 2022

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

June 21, 2022

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

International Collaboration on Pharmaceutical Regulations

June 21, 2022

Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.

MHRA to Play Greater Role in International Medicines Regulation

June 17, 2022

MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

Icosapent Ethyl Gains Nod from NICE

June 17, 2022

NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.

EMA Publishes 2021 Annual Report

June 10, 2022

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.