Regulatory Open Forum

I do a lot of work in risk management for devices including ISO 14971:2007 and EN ISO 14971:2012. I was recently asked about risk management for pharma.

My understanding is that ICH Q9 is the relevant document, and that it is applicable in all jurisdictions. In other words, there are not regional or national variations such as with the EU and devices.

I’d appreciate feedback on this understanding.

Hi Dan,

ICH started with just US, EU and Japan, and now expanded to include Canada and Switzerland.   I think you are right that Q9 is in general recognized as the risk management for pharma vs. ISO14971 for medical device and they do share a lot of similarities.  There are also some other related regional guidance such as "Good practice guide on risk minimisation and prevention of medication errors" and "Safety Considerations for Product Design to Minimize Medication Errors".  Hope this helps.

Juan