| January
5, 2001 - The FDA (Food and Drug Administration) today proposed
a new regulation on current good tissue practice (GTP), which
includes the methods, facilities and controls used for the manufacture
of human cellular and tissue-based products. This proposed rule
is the last of three proposals designed to implement FDA’s
1997 “Proposed Approach to the Regulation of Cellular and
Tissue-based Products”, a comprehensive risk-based regulatory
framework designed to help ensure the safety and quality of
products, including new technologies, without imposing unnecessary
regulatory requirements.
The
purpose of the GTP regulations is to help ensure that donors
of human cellular and tissue-based products are free of communicable
diseases, and that the cells and tissues are not contaminated
during manufacturing and maintain their integrity and function.
Key elements of the proposed rule are:
- Establishment
of a quality program, which would evaluate all aspects of
the firm’s operations, to ensure compliance with GTP;
-
Maintenance of an adequate organizational structure and
sufficient personnel;
-
Establishment of standard operating procedures for all significant
steps in manufacturing;
-
Maintenance of facilities, equipment and the environment;
-
Control and validation of manufacturing processes;
-
Provisions for adequate and appropriate storage;
-
Record keeping and management;
-
Maintenance of a complaint file;
-
Procedures for tracking the product from donor to recipient,
and from recipient to donor.
These
fundamental, base-line regulations would apply to manufacturers
of all human cellular and tissue-based products. In addition,
all of these manufacturers would be required to report adverse
reactions and certain product deviations, have adequate labeling
that is not false or misleading and allow FDA inspections
to ensure compliance with regulations. Certain cellular and
tissue-based products that require licensing or premarket
approval as biological products or medical devices would be
subject to more comprehensive requirements based on their
risks.
Two
other related proposed rules to implement the 1997 regulatory
approach to tissues and cells have already been published.
The first one was (“Establishment Registration and
Listing for Manufacturers of Human Cellular and Tissue-Based
Products”) published May 14, 1998 and required tissue
facilities to register with the FDA and list their products.
This proposed rule is currently undergoing review and is expected
to be published in final form soon. The other one, (“Suitability
Determination for Donors of Human Cellular and Tissue-Based
Products”) issued on Sept 30, 1999, focuses on donor
screening and testing measures to prevent the unwitting use
of contaminated tissues with potential to transmit infectious
diseases.
FDA’s
current regulations addressing tissues were promulgated in
December 1993 with an interim final rule that required the
screening and testing of tissue donors for certain transmissible
diseases such as HIV and hepatitis, as well as the screening
of donors for behavioral risk factors. The final rule,
which was published on July 29, 1997, became effective on
January 26, 1998. The new proposed rules are more comprehensive
and include provisions for the regulation of innovative products.
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