European Regulatory Watch

New Data from EMA’s Review of Medicines with Pseudoephedrine

February 13, 2023

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.

Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine

April 13, 2022

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

AstraZeneca’s Antibody Combination Authorized for Use in Great Britain for Prevention of COVID-19

March 21, 2022

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

FDA to Rely on Real World Data and Evidence for Future Research and Market Approvals

October 01, 2021

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

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

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

Biosimilars: Making the Switch Comes with Challenges

June 01, 2016

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

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

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

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