Regulatory Forum

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FDA COULD DELAY PART 11 REVISION, OFFICIAL SAYS   The FDA is unlikely to complete its long-awaited revision of 21 CFR Part 11 - which regulates the use of electronic records and signatures - by the end of the year as industry observers had expected, an agency official said this month.  "It's a very aggressive timeline, and the regulatory process is very cumbersome, so I have to say it will be difficult to meet that goal, but we are actually working hard toward it, and we have a lot of backing at the FDA keeping us moving along as best we can," said George Smith, consumer safety officer at the FDA's Center for Drug Evaluation and Research.  "The point there is we really want to get it right," he told attendees at a recent Drug Information Association conference.
 

The Cross-Media Electronic Reporting Rule, (CROMERR) 40 CFR Part 3 has been signed by the EPA Administrator as of 22 September 2005!  CROMERR provides a uniform, technology-neutral framework for electronic reporting across all EPA programs; allows EPA programs to offer electronic reporting as they become ready (without any additional rule-making beyond CROMERR); provides states with a streamlined process - together with a uniform set of criteria - for approval of their electronic reporting implementations for all their EPA-authorized programs; and ensures that electronic reporting under EPA and EPA-authorized state programs does not compromise the enforceability of environmental programs.  The original draft rule (Cross-Media Electronic Recordkeeping and Reporting Rule/CROMERRR) received voluminous comments from the diverse stakeholder group at several public hearings, including a very active SQA committee, and formal comment period. Even though the formal comment period ended February 28, 2002, EPA review and rule-making consumed several years navigating the changing landscape of electronic records collection and retention. Subsequently the recordkeeping sections were separated from the reporting provisions to ease the process (in effect changing CROMERRR to CROMERR).
 

Under the North American Free Trade Agreement (NAFTA), EPA and the Canadian Pest Management Regulatory Agency (PMRA) have agreed to harmonize their testing guidelines and have published the following revised guidance document:  NAFTA Guidance for Conducting Terrestrial Field Dissipation Studies.
 

EPA published a proposed rule in the Federal Register on March 11, 2005, entitled "Pesticides; Data Requirement for Conventional Chemicals."
 

Current Activities

The Regulatory Forum includes members of the SQA Specialty Sections. Follow the links to find out about the current activities of the Specialty Sections:

     Animal Health

     Beyond Compliance

     BioAnalytical

     Biotechnology

     Clinical—GCP

     Computer Validation (CVIC)

     GLP

     GMP

     Medical Devices

     Scientific Archiving

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