Quality Systems

Articles

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

DHSC Directs Pharma to Stockpile Medicines

Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.

North Americans Pegged as Least Informed on Pharma GDPR, GlobalData Reports

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

EMA Scales Back Activities to Prepare for Brexit

The European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, to treat certain breast and gastric cancers.

EC Approves Pfizer’s Biosimilar to Roche’s Herceptin

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

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

Pharmaceuticals in the Environment

The recommended drugs include two orphan medicines and three biosimilars.

EMA Recommends Sixteen Medicines for Approval

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines. 


EU and Japan Strengthen Collaboration on GMP Inspection

The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

EMA Reviews Product from China Facility

The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.

EMA Recommends First CART-T Cell Therapies

The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph. 

Regulatory/GMP Compliance, Europe