首页 > 资讯 > EC,EMA与WHO签署合作协议，将共享特定非公开的药品信息

出自识林

2015-09-23 EMA

2015年8月6日，欧盟健康及食品安全总署（EC-DG SANTE）EMA与WHO签署合作协议，将共享特定非公开的药品信息。

这一合作将加强双方的交流，能够更方便和迅速地采取措施保护公众健康。

协议将促进新药在欧盟范围的可及性，避免重复评审，并通过双方最优秀专家的共同参与，改善药品的授权上市和安全性。

协议将进一步加强WHO与EC、EMA的合作.之前，EMA在ICH和IPRF（International Pharmaceutical Regulators Forum）框架下，已在科学和技术上有长期合作的历史。

协议规定，机构各方可以共享以下信息：

• 上市后药物警戒数据，尤其是药品不良反应和由定期安全性更新报告（PSUR）引起的安全性关注；上市后责任和承诺。
• 征求科学建议的申请信息，孤儿药制定，有关重大公众健康利益的上市授权和上市后活动，孤儿药研究计划协议的申请。
• 现场检查、生产设施和临床研究活动及有关报告的相关数据。

该协议已于2015年9月1日开始。

European Commission, European Medicines Agency and World Health Organization step up cooperation to better protect global public health

New working arrangement will allow timely sharing of non-public information

The European Commission and the European Medicines Agency (EMA) have agreed with the World Health Organization (WHO) to share certain non-public information on the safety, quality and efficacy of medicines already authorised or under review in the European Union (EU), or pre-qualified or under review by WHO.

This cooperation will strengthen communication between the respective organisations and make it easier and quicker to take action to protect public health. The arrangement is expected to accelerate patients’ access to new and innovative medicines in the EU, avoid duplication of assessments and improve the authorisation and safety of medicines by involving the best expertise from both sides.

The arrangement further strengthens the collaboration between WHO, the European Commission and EMA who have a long history of scientific and technical collaboration in the context of the International Conference on HarmonisationExternal link icon and the International Pharmaceutical Regulators ForumExternal link icon.

Under the confidentiality arrangement, the organisations involved may share information such as:

• Post-authorisation pharmacovigilance data, particularly related to adverse drug reactions as well as safety concerns arising from periodic safety update reports, and post-authorisation obligations and commitments;
• Information in applications for scientific advice, orphan medicine designation, marketing authorisation or post-authorisation activities of significant public health interest, and applications for agreement of paediatric investigation plans;
• Data related to inspections, manufacturing facilities and clinical research activities and related reports.

This strengthened cooperation started on 1 September 2015.

原文链接 European Commission, European Medicines Agency and World Health Organization step up cooperation to better protect global public health