Pharmacovigilance

In our experience, a request concerning suspected drug toxicity (or an adverse effect) needs to be dealt with in greater detail than other chemical agents, to obtain information on the animals affected (species, breed, age, physiological and pathological status) and on the suspect product (conformity, dose administered, storage conditions, etc.). These led us to introduce a specific request form for drugs, called a ‘pharmacovigilance form’, used since October 1988.

But it appears repurposing is possible in another crucial phase of drug development—post-marketing surveillance or pharmacovigilance, which essentially identifies adverse side effects of drugs. Experts say “repurposed” pharmacovigilance would look for and understand beneficial side effects of drugs that may surface during their development or use.

Since it [the European Medicines Agency] began operating in 1995, the agency has become a central actor regarding various aspects of pharmaceuticals regulation and has a crucial role in providing the infrastructure for EU [European Union] pharmacovigilance.