Pharmacovigilance – Legislation and Regulations

Pharmacovigilance is the science of drug safety, a combination of pharmacoepidemiology and pharmacology. It provides the tools to help assess risk vs. benefit, to detect signals in data that point to an adverse event, and to help assess the significance of these signals.

Pharmacovigilance Pharmacovigilance training institute in hyderabad legislation provides a raft of measures that pharmaceutical companies and governments must adhere to in order to protect people from potentially harmful adverse effects. It’s at this point that things get complicated. The US, the EU, Japan and the rest of the world have got together and created a set of general principles, through the WHO, on which to run their drug safety procedures. The US has a set of rules.

The EU also has a set of rules which is similar to the set the US has. The EU’s rules are implemented by member countries, each of which implements them slightly differently with subtle and not-so-subtle differences and the EU rules also apply in parts of Europe that are not part of the EU. The rest of the world uses the set of rules drawn up by the World Health Organization but each country implements them differently. All of these rules are supposed to be the same or at least pulling in the same direction but frequently they aren’t.

The laws governing pharmacovigilance lay down strict instructions on what pharmaceutical companies must do in the event of detecting a serious adverse event, and indeed what constitutes a serious adverse event. The laws describe how such events must be reported to licensing authorities and in what timescale, how the information that pharmaceutical companies and governments collect on adverse events must be stored and the systems which should be used for this. The laws in the European Union also make demands on the pharmaceutical companies in terms of employing the services of a qualified person for pharmacovigilance and a risk management plan to minimize risk to patients.

You can read more about the rules on pharmacovigilance and how your company can comply with these rules at the site of the Pharmacovigilance Information Service.