The European Medicines Agency (EMEA) has urged for greater international cooperation as it outlined how to prevent a repeat of the heparin crisis.
This process is already underway, with the FDA joining with regulatory bodies in Europe, Canada and Australia on a pilot project for joint inspections of overseas active pharmaceutical ingredient manufacturing plants. By cooperating the EMEA believes regulatory bodies will be more successful in monitoring an increasingly complex global supply chain. Thomas Lonngren, head of the EMEA, said: "Heparin is a classic example of how things can go wrong. We have to see how, on an international level, we can cooperate in order to ensure that those regulatory agencies in Asia and China are up to standard in order to control their market and their manufacturing." The EMEA believes this increased regulatory cooperation will also help in the fight against counterfeiting, with Lonngren saying "it goes hand in hand" with normal manufacturing in some countries.
To reduce the likelihood of future contaminations the EMEA also calls on the European Commission to strengthen control of the supply chain through modifications to the legal and regulatory framework. In addition the EMEA requests that specific tests for oversulphated chondroitin sulphate (OSCS), the deadly contaminant in heparin, be incorporated into heparin monographs in the European Pharmacopoeia. Through these measures the EMEA believes it will be better equipped to protect the populace from a deadly contamination in the future. Heparin, which has been linked to 81 deaths, has highlighted the difficulties in policing a complex global supply chain.
Lonngren said: "This is a new scenario for us as regulators on both sides of the Atlantic. Suddenly we discover that we have important manufacturing far away that we don't have any control of."
As well as looking at how to prevent future incidents the EMEA also clarified the current risks posed by heparin in the EU, giving guidelines to doctors on how to minimise the risks.