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Dear Sivakumar,

From a european perspective, post marketing surveillance process are monitored by the health authority bodies (i.e. AFSSAPS in France, DGFPS in Spain) in partnership with manufacturers.

Would be glad to further discuss this if needed. If your request is only US focus, then good luck !

Regards,

Arnaud

Dear Arnaud,

Thank you for your information, my request is not only US focus and it is for all over the world with various regulatory agencies approach. I would be grateful if you share some more information on methodology used for post-marketing surveillance in EU.

With Regards

Sivakumar

Both the FDA and the EMEA have regulations and extensive guidances regarding postmarket surveillance.  The regulations require that post-marketing adverse events be reported to a regulatory body.  They lay out criteria for what events are reportable, based on the seriousness of the event, whether or not it is already listed on the drug label, and how long the drug has been on the market.  There are provisions that call for expedited reporting (typically within 15 days) when the company learns of a serious unlabled adverse event.  In the US (but less so in Europe), healthcare providers and consumers can also report postmarketing adverse events directly to the FDA through the MedWatch system.

The key to all of it is getting a well-written case report, which is harder than it sounds.  A good place to start on the US FDA side is the guidance on good pharmacovigilance practices, which can be found at http://www.fda.gov/cder/guidance/6359OCC.pdf , and the guidance on periodic safety update reports at http://www.fda.gov/cder/guidance/1351fnl.pdf .  For Europe, I’d refer you to the EudraVigilance web site, http://eudravigilance.emea.europa.eu/human/index.asp .

My work for the past several years has been on data-mining in databases of “spontaneous reports” to identify safety issues.  As you will see from the guidances, the application of data mining algorithms to these databases, in addtion to the “traditional” method of having a physician read each case report, is not a regulatory requirement, but has shown value and is becoming more and more common.

I’m happy to discuss more specifics on post-marketing surveillance with you, either on this board if there are topics of general interest, or my private message if you have specific questions.

I work with drug safety and clinical research, in the pharma and in the university ( Brazil) . In my country our health authority ( ANVISA) use the mark regulatory similar to the of FDA and EMEA. I'm very happy for recent discusion on risk management , for the ANVISA.

I have very concern in  studies fase IV ,pharmacoepidemiologic studies

Regards,

Hilton