Beginning this month, drugmakers and competent authorities must report all adverse drug reactions — not just serious ones — to the EU’s centralized EudraVigilance database.
The adverse event reporting requirements are one of a number of changes being implemented under new pharmacovigilance legislation that took effect July 2. The overhaul, which entails some major adjustments in companies’ IT and reporting systems, could be costly for manufacturers, industry said.
Under the new law, marketing authorization holders (MAH) are required to use an electronic format to submit information to the European Medicines Agency (EMA) on drugs authorized or registered in the EU. Drugmakers are responsible for maintaining this information once it’s submitted and for alerting the agency to any new or varied marketing authorizations granted by individual EU countries.
These new regulations will force myriad changes in the way you do business in Europe: new and changed definitions, new regulatory bodies and new reporting requirements.
Right away, you’ll face two major challenges:
- Adoption of good pharmacovigilance practices; and
- Creation of pharmacovigilance system master files to supplant detailed descriptions of pharmacovigilance systems currently in use.
Fortunately, help is at hand with FDAnews’ EU Pharmacovigilance: 2012 Compliance Guide. This standout new management report could not have come at a better moment.
With so much of the drug and biologics trade depending on global sales, it’d be foolish to stick your head in the sand regarding these new EU regulations. Don’t take the risk of failing to comply. Order your copies today.