For most of us, it's simply a mouthful: pharmacovigilance.
But for drug manufacturers, it is critically important to collect, monitor, research, assessing, and evaluate information from healthcare providers and patients on the adverse effects of medications. So, pharmaceutical and biotech companies are paying close attention to EMA's looming new pharmacovigilance legislation.
Major changes to the legislation covering pharmacovigilance in the European Union (EU) were announced on December 31, 2010. This is the biggest change to the regulation of human medicines since 1995 and will have significant implications for drug safety. The new laws will apply from July 2012 and have three broad objectives:
- to strengthen post-authorisation regulation of medicines,
- to improve efficiency, and
- to increase transparency.
Agencies and biopharmaceutical companies, start your engines; July 2, 2012 is just around the corner!
[Tip of the hat to Kathie Clark!]
To find out more about this topic, take a look at the following:
- Complying with EMA's new requirement for medicinal product information
- Electronic submission of information on medicines
- Meeting the linguistic requirements for EMA submissions
- Periodic Safety Update Reports: Be Compliant and Cost Effective
ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.