For the uninitiated:
To build and update the safety profile of a medicinal product, it is necessary to collect and evaluate reports from healthcare providers, patients and the scientific literature on all adverse events that occur in connection with the use of the medicine.
As a result of the monitoring of adverse events, over the course of time, new information about the hazards associated with a particular medicine can come to light. Any changes to the safety profile need to be reflected in the Summary of Product Characteristics and Patient Information Leaflet, the updated information ultimately helps to prevent harm to patients.
The WHO definition is: Pharmacovigilance is concerned with the detection, assessment and prevention of adverse reactions to drugs.
According to European Directive 2001/83/EC and its subsequent amendments, the holders of marketing authorisations are required to have a functional pharmacovigilance system in place. This is to ensure that they can detect, receive and adequately respond to any information that is of relevance to the safety of the medicinal products they place on the market.
The overall objective is the safer administration of medicines
Although not compulsory it is difficult to carry out signal monitoring (which is a legal requirement) without a data base in place. At CambReg we use TARA a cost effective solution for the discerning client.
TARA is a pharmacovigilance data base, deployed in the United States, Australia, India, and across Europe. Built and maintained by pharmacovigilance and IT experts, TARA provides all the functionality required to manage adverse event collection and reporting duties, providing an extensive list of capabilities including report generation (including but not limited to CIOMS I, MedWatch 3500A, VAERS), dictionary input and access (including but not limited to WHO, MedDRA, and PubMed), and many others. TARA facilitates faster and easier management of adverse reactions with its use of configurable workflow, customisable console, and straightforward end user and administrative setup. TARA is ISO 9001 accredited and CRF 21 Part 11 compliant.
You must have a system in place by the time you make your first Marketing Authorisation Application for a medical product (including generics and herbal medicines). You have two main options: