Regulatory/GMP Compliance, Europe

European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

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

The agency launches initiative to stimulate pediatric drug development.

The agency has recommended granting marketing authorization for Opdivo.

The European Medicines Agency releases findings from marketing authorization application analysis.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Early access to Merck’s Keytruda in the United Kingdom is granted under the UK’s Early Access to Medicines Scheme.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

Investors are lining up for the biosimilars market as patents reach expiration and regulatory pathways are defined.

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

The agency creates an electronic central repository to facilitate drug safety assessment reports.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

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.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.

The European Medicines Agency responds to the European Ombudsman's letter regarding redacted documents.

The authors take a look at some of the recent developments in the German pharmaceutical market.

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

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

AbbVie announced that FDA and EMA have granted orphan drug status to its investigational anti-epidermal growth factor receptor antibody drug conjugat, ABT-414, for the treatment of glioblastoma multiforme.

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.