FDLI book maps out multi-country pharmacovigilance

As recent events clearly indicate, the need to keep a close eye on pharmaceutical safety does not end with government approval to market  the drug, says the USA-based Food and Drug Law Institute.

In March 2008, shipments of the blood thinner heparin made in China were  discovered to be contaminated with excess sulfates often used to treat  arthritis. The contaminated heparin caused dozens of deaths and hundreds  of injuries. In February this year, the Food and Drug Administration  accused Indian generic drugmaker Ranbaxy of falsifying data used to  obtain regulatory approval for US distribution (Marketletters passim).

These developments are just a few examples of why pharmacovigilance is  now a global concern, notes the FDLI. Pharmacovigilance encompasses all  phases of a product's lifecycle - from data supporting regulatory  approvals to enter a market to periodic inspections of foreign  manufacturing facilities to post-marketing surveillance and adverse  event reporting - and beyond. Many countries are working feverishly to  develop their own set of pharmacovigilance laws and regulations, and it  is increasingly difficult for manufacturers to keep current on new  requirements.