Less red tape, not more? Yes, it's true. The FDA has proposed new rules that would ease the burden of notifying the agency of every single change in manufacturing processes, in-Pharm reports. The rules would allow companies to report certain minor changes all at once, in an annual report that would not only cut the workload for pharma, but streamline the agency's work too.
The proposal lists about 40 changes eligible for such an annual report, focusing on chemistry, manufacturing and controls (CMC) changes that, in the FDA's estimation, pose little risk of affecting product quality. For instance, replacing a piece of equipment with another that's designed the same way, changing a supplier of inactive ingredients or adding an additional product to the line-up in a manufacturing area already approved to handle multiple products.
FDA is pitching this overhaul to the reporting system after the number of CMC changes filed mushroomed in recent years. Rather than spending time and money on reviewing them all, the agency figures a risk-based approach would be more efficent.
- get the guidance from FDA
- read the in-Pharm story