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TextDrip Sinan
On February 18, 2022, the CDE official website released the Friday homework - "Guidelines for the Acceptance and Review of Traditional Chinese Medicine Registration" (draft for comments).
Have the medical practitioners completed the weekend homework on time? The publicity date of this draft is: February 18, 2022 to March 4, 2022, nearly 16 days have passed since the release of CDE's "Notice of the Guidelines for Registration Acceptance and Review of Traditional Chinese Medicines (Trial)" (No.
34, 2020) In January, CDE also made corresponding adjustments to the acceptance review of traditional Chinese medicine registration
.
This notice has attracted the attention of registered professionals, especially Chinese medicine manufacturers
.
This article compares and analyzes the main new and revised contents of the new and old editions of the "Guidelines for the Acceptance and Review of Registration of Chinese Medicines", hoping to help everyone do a good job in the registration of Chinese medicines
one
oneBackground of revision of "Guidelines for Acceptance and Review of Registration of Chinese Medicines"
Background of revision of "Guidelines for Acceptance and Review of Registration of Chinese Medicines"In order to better guide the registration of traditional Chinese medicines, in accordance with the relevant provisions of the "Drug Administration Law" and "Administrative Measures for Drug Registration" and related supporting documents, comprehensively summarize the latest requirements and work experience of traditional Chinese medicine registration, and revise the draft of this guideline for comments.
, the revision background mainly comes from:
(1) "Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the Guidelines for the Acceptance and Review of Traditional Chinese Medicine Registration (Trial Implementation)" (No.
34, 2020), which was issued and implemented on October 22, 2020, and collected information on the implementation process.
In order to update and disclose the acceptance standards in a timely manner, improve the quality of acceptance work, and better serve Chinese medicine applicants
.
(2) In order to implement the requirements of the Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes (for Trial Implementation) (No.
89 of 2020), CDE intends to revise the guidelines for the acceptance and examination of traditional Chinese medicine registration
.
The early resolution mechanism for drug patent disputes refers to a system that links the relevant drug marketing approval procedures with the relevant drug patent dispute resolution procedures
two
twoAnalysis of the proposed additions and revisions
Analysis of the proposed additions and revisions2.
2.
2.
2.
references
[1] CDE official website, etc.
