The European Medicines Agency has published a guide to support implementation of a new international standard for the safety monitoring of medicines due to go live in July 2016.
The new standard - called ISO ICSR - is designed to improve reporting of suspected side effects in Individual Case Safety Reports (ICSRs), and establish the same formats for cases across the world.
It also is expected to include better information on medicines that might be associated with an adverse drug reaction and on the therapeutic uses of those medicines, and also strengthens personal data protection in ICSR ICSRs collected by pharmaceutical companies and regulatory authorities.
This, says the EMA, will improve the quality of data collected the ability to search and analyse them, while regulatory authorities will be able to detect and address safety issues with medicines more quickly.
Access the guide here.