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Submission and Review Process in the EU

Submission and Review Process in the EU 117 INSTRUCTIONS FOR FILLING OUT FORM FDA 3S6h... [Pg.117]

The evaluation of the safety of a new excipient as a food additive could be accomplished by the submission of a food additive petition to the United Nations expert panel operating under the auspices of the FAO and the World Health Organization known as the JECFA. A JECFA review could serve as a separate independent safety review to support the new excipient for potential use in drug products. Alternatively, the safety of a new excipient could be evaluated through the food additive petition processes, as currently in practice both in the United States and the EU, assuming that the new excipient can be demonstrated to have a technological function as a food additive. [Pg.70]

See other pages where Submission and Review Process in the EU is mentioned: [Pg.114]    [Pg.115]    [Pg.119]    [Pg.121]    [Pg.114]    [Pg.115]    [Pg.119]    [Pg.121]    [Pg.127]    [Pg.194]    [Pg.477]    [Pg.393]    [Pg.206]    [Pg.51]   


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