What is a Safety Signal?
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new...
Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch
In the process of marketing authorization, competent authorities classify medicinal products as the subject or not-subject to medical prescription. However, the classification of medicinal products can be reevaluated and changed via a regulated procedure. When...
Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions
Pharmacovigilance legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each marketing authorization holder (MAH) to perform literature review in countries where their products are present. According to...
