How Does the Pharmaceutical Industry Really Work? FDA Wants its Managers to Know

Posted 06 February 2015 | By Alexander Gaffney, RAC 

How Does the Pharmaceutical Industry Really Work? FDA Wants its Managers to Know

The Center for Drug Evaluation and Research (CDER) has announced that it plans to continue a program which allows pharmaceutical companies to invite regulators to visit their manufacturing sites to better understand how the industry operates.


The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the "Site Tours" program, has been in effect in various forms since 1999, when it was created by CDER's Training and Certification Subcommittee.

"The goals of the program are to provide firsthand exposure to the industry's drug development process, a venue for sharing information about regulatory project management (but not drug-specific information), and an opportunity for CDER's regulatory project managers to fulfill an industry site tour requirement as part of CDER's Regulatory Project Management Certification program," FDA explains in its Manual of Policies and Procedures (MAPP) on the topic.

These site tours are funded by FDA and done on a voluntary basis with the cooperation of pharmaceutical companies, with priority given to those companies whose facilities have not been toured in the last three years. Those companies should not have "outstanding actions" related to enforcement decisions or use fees, FDA noted, though they are not mandatory exclusionary criteria.

The inspections themselves typically last between two and three days and are meant to be an in-depth look at manufacturing operations by fewer than five regulatory project managers, including senior-level managers.

The site tours also feature "daily workshops" which focus on specific regulatory matters "important to both CDER staff and industry."

"The primary objective of the daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms, and regulatory submission operations," FDA explained.

Regulators said the ultimate goal of the program is to increase the exposure of their project managers to the techniques and processes used by the industry in the hopes of allowing them to obtain a better understanding of how the industry works from within and regulates its products.


FDA has now once again extended the life of the Site Tours program for an additional year, according to a posting in the Federal Register.

Companies wishing to participate in the program should contact FDA by 7 April 2015 with their proposed agendas for the visit.

As Focus has noted in the past, the program is looking for companies without compliance issues, but is not intended "as a mechanism to inspect, assess, judge or perform a regulatory function."


Federal Register notice

Categories: Regulatory News

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