UK Streamlines Regulatory Pathway to Accelerate Market Access by 3–6 Months.

The FDA has announced FDA PreCheck— a program to boost domestic drug (API) manufacturing.

The program includes two phases:

1.Facility Readiness Phase – Early FDA input on facility design, quality systems, and operational maturity through a Type V DMF.

2.Application Submission Phase – Enhanced support during drug application development, including pre-submission meetings and feedback on the CMC section.

With only 11% of API makers based in the U.S., this two-phase initiative offers early FDA engagement and faster reviews to help bring facilities online quicker and more predictably.

For pharma manufacturers, this means:

• Reduced regulatory risk

• Accelerated CMC timelines

• Stronger U.S. supply chain positioning

There will be a public meeting on Sept 30 where the FDAPreCheck draft framework will be presented and discussed — a key chance for pharma industry professionals to get to know more and help shape the future of U.S. pharma manufacturing.

#FDA #PharmaManufacturing #SupplyChainResilience #RegulatoryAffairs #API #FDAprecheck

https://www.gov.uk/government/news/patients-will-receive-medicines-3-6-months-faster-under-10-year-health-plan-as-regulators-set-out-plans

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