Quality Systems

Articles

EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

EMA Recommends New Measures to Avoid Potentially Fatal Dosing Errors with Methotrexate

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

FDA Expands Scope of API Impurity Investigation

Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.

Analysis Shows that EU and US are Highly Aligned for Marketing Decisions

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

Biosimilar Teriparatide Launches Across Europe

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

European Commission Extends Use of Dupixent to Include Adolescents

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.

Regulatory Harmony

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

European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.


One Small Step for Man, One Giant Leap for Pharma Regulators

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.


Farther Than the Eye Can See

Much has changed in the bio/pharma industry over three decades. In this special feature, the editors take a trip down memory lane, highlighting some of the major happenings of the past 30 years.


Standing the Test of Time

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.


Regulatory/GMP Compliance, Europe