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SFDA issues Requirements for Drug Excipients Registration Application Materials



To standardize the application of drug excipient registration, the Department of Drug Registration of the State Food and Drug Administration (SFDA), while considering related provisions, issued Requirements for Drug Excipients Registration Application Materials on June 21, 2005 to provincial-level food and drug administrations (drug administrations), requiring applicants of drug expicients registration to submit application materials as stated in the Requirements.

The Requirements covers the application materials regarding:
new drug expicients;
imported drug expicients;
drug expicients admitted by national standards;
pharmaceutical empty capsules, capsule gelatins and pharmaceutical gelatins admitted by national standards;
supplementary application for drug excipients;
drug excipient re-registration.