Regulatory/GMP Compliance, Europe

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).

Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

CHMP has recommended that the indication of Victoza (liraglutide) be extended to include its use in pediatric patients with Type 2 diabetes.

During its biannual meeting in Amsterdam, ICH approved four new regulatory observers and reviewed the progress made on global harmonization efforts.

CMA has issued a statement of objections provisionally finding that four pharmaceutical companies have broken competition law.

SenzaGen has revealed that is has been granted a patent in Europe for GARDpotency, a testing application that enables the measurement of the allergenicity of chemical substances without animal research.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has issued a drug alert concerning a class 2 medicines recall of paracetamol tablets.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.

Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.

FDA’s annual manufacturing report card shows more quality compliance is needed.

The current fragmented regulatory approach to cannabis medicines across Europe is challenging to harmonize.

Discussing supply chain risk and security as a business led journey, Roddy Martin, chief digital strategist at TraceLink, explains the five stages of its evolution.

Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.

The European Medicines Agency has issued a vacancy notice for the position of executive director.

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

Empty and prefilled syringes must pass a range of quality control tests.

It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States

EMA has launched a social media campaign aimed at highlighting how the agency and its network maintain safety and efficacy of medicines available in Europe.

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

The UK’s General Pharmaceutical Council (GPhC) has strengthened its guidance for online pharmacies to further safeguard patients when purchasing medicines.

The CHMP has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the EU as a substitution treatment for opioid dependence.

EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.