CDE first publicizes the list of reference preparations that have not passed the review
Release date: 2020-01-10 Views: 0
On January 10, the CDE publicly published the 25th and 26th lists of the "Reference Catalog of Chemical Generic Drugs" and solicited comments, including a total of 353 specifications, of which 111 were injections; it also included inhalants, ophthalmic preparations, ointments , Patch and other dosage forms.
Publicity period: January 10, 2020 to January 23, 2020 (10 working days).
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Among them, for the first time, the list of varieties of reference preparations that had not passed the review was publicized, and 29 batches of a total of 29 product regulations failed to pass the review.
Most of the reasons that did not pass the review were modified dosage forms, which were not available in the original research.
The Insight database shows that there are currently 24 batches of reference preparations published by the State Food and Drug Administration (25 and 26 are drafts for comments), involving a total of 2452 product specifications.
Injectable reference preparations began to appear in the 21st batch of reference preparations. Up to now, with the 23rd batch and 24th batch of reference preparations just released by NMPA, the injection reference preparations have reached a total of 640 specifications.
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