WHO, EU, EMA agreement to improve quality and safety of medicines

With globalized markets and increasing cross-border trade, protecting patients from unsafe, substandard and dangerous medical products requires global action based on information sharing and collaboration between many actors involved in medicines oversight.

WHO, the European Commission and the European Medicines Agency (EMA) have signed a confidentiality agreement to start sharing information on the safety, quality and efficacy of medicines already authorised or under review in the European Union (EU), or prequalified or under review by WHO.

The arrangement strengthens an already solid collaboration between the agencies in the context of several international harmonization and convergence initiatives and bilateral arrangements. Under the new agreement, EMA and WHO can share information such as drug safety data on products already on the market, particularly related to adverse drug reactions and other safety concerns; information on applications for scientific advice, marketing authorisation or post-authorisation activities of significant public health interest; and data related to inspections of manufacturing facilities and clinical research activities.

The cooperation will also make it easier and quicker to take action to protect public health when defective medicines threats emerge.

The WHO-EMA agreement is expected to avoid duplication of quality assessments, thus accelerating patients’ access to quality treatment, and improve the authorisation and safety of medicines by involving the best expertise from both sides.

(Source: WHO)