Woodcock: US-Europe Mutual Inspection Program a Priority
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said June 1, adding that the current system of different expectations is not sustainable.
There is no firm timeline, but Woodcock said the agency is trying to get something established as quickly as possible. The effort is being led by Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg.
Speaking at the ISPE/FDA/PQRI Quality Manufacturing Conference in Washington, D.C., Woodcock said a system of mutual reliance will allow inspections performed by the FDA to be acknowledged by EU regulators and vice versa. This will eliminate overlap of inspections and allow and focus resources on facilities that haven’t been inspected recently.
Though the FDA and its EU counterparts are still in the early stages of harmonizing their inspection programs, the long-term goal would appear to be along the lines of the medical device single-audit program currently being piloted by the FDA and other global regulators.
The effort comes with its challenges — notably, gaining an in-depth understanding of each other’s regulatory systems, data sharing and differences in the EU and U.S. legal frameworks, Woodcock said. An FDA lawyer is working to ensure the process is legally vetted according to the laws of multiple EU member states, she added.
The FDA is also encouraging individual EU countries to better align their regulatory systems so the agency doesn’t have to deal with them one by one, Woodcock noted. This could benefit countries by allowing them to pool limited resources with those of other member states.
While Europe is the priority, the ultimate goal is to one day have worldwide convergence with regulatory agencies, Woodcock said. — Kellen Owings
Subscribe to Generic Line and save $250 off the regular one-year price of $1,097 — plus receive a FREE copy of our webinar, Expediate Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time — a $287 Value!
LINKS TO KEY DOCUMENTS — Each issue provides you with links that support GEN's articles such as FDA guidances, warning letters, rules, full texts of proposed legislation and more.
FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.
ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.
Copyright ©2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing