mdi ConsultantsNO SURPRISE – But a long time coming.
Josh Hawley (R., Mo.) announces a new bill “The Medical Supply Chain Security Act” which will help reduce the reliance on Chinese medical supply chain. This is due to the current coronavirus outbreak and addresses potential shortages. The new bill amends “shortage of a drug” to add, “shortage of a drug or device.” It will also allow the FDA to expedite the review process of a device subject to premarket approval intended to help mitigate and/or prevent a shortage. Manufacturers would also have to report to the FDA on an annual basis information related to “manufacturing capacity” of a drug or device. These details include:
- All locations of production
- Sourcing of all component parts
- Sourcing of any active pharmaceutical ingredients
- The use of any scarce raw materials
As well as any other information to be relevant to the security of the supply chain of the drug or device.
We saw this coming, it is not a surprise. Unfortunately, it always takes a crisis to have our Congress take some actions. We saw this coming a long time ago. We have been involved in dealing with companies in China since 1993. And the involvement of US companies committing themselves to using Chinese manufacturers has only grown.
As this bill progresses mdi will keep our clients updated on any new information and requirements. We will be here to assist with any of your company’s registration needs.
If you have any questions, please feel free to reach out to us via email at [email protected] RE: “The Medical Supply Chain Security Act.”