New Draft for FDA Globalisation Act Calls for Quality Risk Management Plans

Within the framework of several Congress hearings, it became clear that the FDA only inspects a small part of the companies shipping medicinal products or active ingredients to the USA. This is meant to change. A planned "FDA Globalisation Act" is intended to require companies to manufacture medicinal products according to self-defined "Quality Risk Management Plans".

The contents of such a plan focus unambiguously on ICH Q9. The draft lists the same elements of the risk management process as Q9 (risk assessment, risk control, risk communication and risk review). Apart from this, a regular update will be required. The text explicitly points out that the qualification of suppliers and of contractors (contract manufacturers and laboratories) will have to be integrated into these "Quality Risk Management Plans".

Even penalties in case of a non-existing Quality Risk Management Plans with regard to putting in circulation adulterated or misbranded medicinal products are already mentioned in the document.

The FDA, too, is meant to be able to prolong the usual 2-year inspection cycles to 4 years on the basis of a risk assessment. These risk-based inspections are intended to be possible on the basis of sufficient information (e. g. compliance and inspection history). This assessment is meant to become possible at the latest 3 years after the law has come into force by means of establishing a suitable information system.

It is still too early to predict the consequences of this draft in concrete terms. However, what is certain is that, in the future, the issue of Quality Risk Management will play a major role with the FDA - and with the companies supervised by this authority.

The draft for the FDA Globalisation Act can be found here.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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