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FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation

Sep 7th, 2011

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FDA’s growing experience with the field offices it has established in India, China and eight other countries is substantiating their benefit in boosting the agency’s efficiency and effectiveness in regulating a global supply chain.

The officials staffing the offices are realizing the effectiveness they have as information conduits – reporting activities taking place in their respective countries to FDA headquarters and educating regulators and manufacturers in the host country on FDA policies and requirements.  In turn, they are working with the host country to build relationships and coordinate and strengthen local processes while better targeting FDA’s own inspection and enforcement oversight.

At the 2011 University of Georgia/FDA International GMP Conference in Athens, Georgia, FDA India Office Director Bruce Ross gave an insightful presentation on the forces that led the agency to create the overseas offices and their effectiveness to date in meeting the objectives.

“I think of these foreign offices as portals through which a variety of information flows,” he commented.  The “presence in the country” allows questions to be fielded from FDA headquarters as well as local manufacturers and regulators and better answers to be provided.  “We are in the right time zone.  We have made contacts.  We know who to talk to.  We can vet those answers.”

In his presentation, Ross discussed: ● the “global realities,” including “facts” “challenges” and “lessons learned” ● international cooperation activities ● the agency’s “Beyond Our Borders” initiative, and ● the challenges and accomplishments of the India office in particular (Ross’ complete remarks are provided below).

[The story continues for subscribers beginning on page 2.  Nonsubscribers can purchase the full story along with the companion story on international inspection information-sharing for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

Also see related stories:

International Information Sharing is Impacting FDA Inspections/Enforcement Abroad

India Strengthening its Central Regulatory Authority to Keep Pace with Industry Expansion

Potential GMP Trouble Spots at India’s API Firms Include Equipment Handling, CAPA, Documentation, and Training, India Auditing Expert Finds

FDA’s Focus On Lab Practices Abroad Continues in Four Recent API Warning Letters

Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India

FDA Micro Lab Data Concerns Continue with Warning Letter to Second Indian Firm

Special Report on US and Europe GMP Enforcement Activity

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