Quality Systems

Sean Milmo is a freelance writer based in Essex, UK.

Articles

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

New Regulations for Combination Products

The pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.

Brexit Sparks Uncertainties

The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.

Pharmaceuticals in the Environment Spark Controversy

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

Biosimilars: Making the Switch Comes with Challenges

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.

EU on a Mission to Boost R&D

The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.

Europe Moves Forward on Anticounterfeiting Measures

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.

Tackling Regulatory Challenges of EU’s Variations Framework

The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.

EMA Outlines Network Strategy for Next Five Years

Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.

A Call for Radical Reformation of the World Health Organization

Finalizing GMP requirements and quality standards for the development,
manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

European Regulatory Watch