What changes can we expect?
The latest update to the guidance of routine signal detection methods used by the EMA, regulatory authorities of the Member States and marketing authorisation holders was published in December 2016. This guidance only provides discussion on the recommended methods for screening for adverse reactions.
In August 2016, the European Commission published a three-year report on pharmacovigilance tasks by Member States and EMA, containing key activities undertaken during the reporting period, a high-level description of the EU pharmacovigilance system, the key achievements of recent years, as well as ways for future improvement.
Regulatory requirements are set in GVP Module IX on signal management. Public consultations on GVP Module IX – Signal management (Rev 1) and revised guidance on statistical methods (addendum I) ended in October 2016. Its anticipated date for coming into effect is Q1 2017. Revision 1 includes major modifications based on experience gained over the past four years.
What are the major changes Revision 1 will bring?
1. There are strict timelines for safety review for types of products and maximum timelines for signal approaches based upon the type of product.
2. In 2017, the EudraVigilance database will be made available to all Companies. Signal detection using this system for quantitative analyses will be mandatory.
3. To ensure people are trained in these aspects, there will be training courses operating for people to attend and pass a test to use the database.
4. There will be a new mechanism in place to alert Regulators when a signal is identified.
5. There will be strict timelines applied for licence variations based upon the level of patient risk identified from the signal assessment. The maximum will again be three months. Urgent safety restrictions: 48 hours. Other timelines are set at one month.