European Regulatory Watch

EMA’s CHMP Recommends 13 New Medicines for Approval

September 24, 2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.

The Evolving Role of HTA Bodies Sparks Scrutiny

January 01, 2017

BioPharm International

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?

Biosimilars: Making the Switch Comes with Challenges

June 01, 2016

BioPharm International

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.

GMP Challenges for Advanced Therapy Medicinal Products

December 01, 2015

BioPharm International

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.

Unravelling the Complexity of EU’s ATMP Regulatory Framework

July 01, 2015

BioPharm International

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

Labeling of Biosimilars

February 01, 2015

BioPharm International

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Great Expectations from New European Commission

January 01, 2015

BioPharm International

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

Extending the Scope of Pharmacovigilance Comes at a Price

September 01, 2014

BioPharm International

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

EU Steps Up Inspection Efforts

May 02, 2014

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

Quality by Design—Bridging the Gap between Concept and Implementation

April 01, 2014

BioPharm International

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.