Quality Systems

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

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

Is it Time to Update cGMPs?

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


CHMP Recommends Extension to Victoza Indication for Treatment of Pediatric Type 2 Diabetes

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

ICH Approves Four New Regulatory Observers and Reviews Progress of Harmonization Efforts

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

CMA Accuses Four Pharma Companies of Illegal Anti-Competitive Conduct

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.

SenzaGen Gains First Patent for GARDpotency

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.


MHRA Issues Class 2 Medicines Recall Drug Alert

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. 

Luxembourg and the Netherlands Added to EU–US Inspections Agreement

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

Consultation Opens on EMA’s Draft Guidelines on Drug-Device Combination Products

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

European Commission Grants Conditional Marketing Authorization for Zynteglo

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

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

Regulatory/GMP Compliance, Europe