Quality Systems

Articles

EMA's CHMP has adopted a positive opinion for Dapivirine Vaginal Ring for women in non-EU countries where HIV disease burden is high.

CHMP Adopts Positive Opinion for Dapivirine Vaginal Ring

Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).

EC Grants Marketing Authorization for Remsima

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

EMA Sets Up Infrastructure to Support Real-World Monitoring of COVID-19 Vaccines

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

EMA Issues Final Opinion on Nitrosamines

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

Regulatory Authorities have Published a Report on COVID Vaccine Development

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

European Commission Approves Lynparza for BRCA-Mutated Metastatic Pancreatic Cancer

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

EDQM Publishes New General Chapter in European Pharmacopoeia Supplement 10.3

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

There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.

Learning Regulatory Lessons in Times of a Crisis

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

EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.  

Business on Hold? EMA’s Full Recovery in Question

EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union. 

Regulatory/GMP Compliance, Europe