European drug agency will have greater role in drug safety monitoring

New legislation this year will give European drug regulators a more significant role in post-market drug safety monitoring, and time will tell whether even more control might be needed, according to an EC official.

Guenter Verheugen, EC vice president, told a meeting of the European Medicines Agency (EMEA) that government agencies cannot know the safety profile of all pharmaceuticals at the time they are granted marketing approval.

“We must have systems in place to learn more about the safety of medicines once they are marketed,” Mr. Verheugen told the agency, according to a Reuters news report.

New EU legislation, slated to go into effect this year, will allow the EMEA to play a more significant role in monitoring the safety of marketed pharmaceuticals after launch, according to Reuters.

“An ongoing study launched by the Commission into the robustness of the system should tell us whether these measures are sufficient,” Mr. Verheugen said, according to Reuters.

In a separate Reuters item, Novartis chairman and chief executive officer Daniel Vasella asked European regulatory agencies not to over-react to recent pharmaceutical product withdrawals when considering new medicines for approval. An over-cautious regulatory process would “stifle innovation,” he told the EMEA, according to Reuters.

“We cannot succumb to the temptation to require enormous studies as a prerequisite for approval, extending development times, increasing already immense costs and reducing the time to earn back a profit,” he said.