Another 13 references failed the second review, and CDE publicly solicited the "List of Chemical Generic Drug Reference Preparations (48th Batch)" (Draft for Solicitation of Comments)

CDE publicly solicited the "Catalogue of Chemical Generic Drug Reference Preparations (48th Batch)" (Draft for Solicitation of Comments), with 17 releases and 46 additions, and another 25 reference preparations failed the review, including 13 reference preparations The second review failed!

Before:

Previously released by CDE:

On August 3, 2021, the 47th batch of reference formulations for solicitation of comments, 29 failed to pass the review, of which 6 failed to pass the second review!

On June 29, 2021, the 46th batch of reference formulations for solicitation of comments, 12 failed to pass the review,

On June 4, 2021, the 45th batch of reference formulations for solicitation of comments, 26 failed to pass the review, of which 4 failed to pass the second review!

On May 21, 2021, the 44th batch of reference formulations for solicitation of comments, 30 failed to pass the review

On May 17, 2021, the 43rd batch of reference formulations for solicitation of comments, 44 failed to pass the review

On April 15, 2021, the 42nd batch of reference formulations for solicitation of comments, 8 failed to pass the review

On March 12, 2021, the 41st batch of reference formulations for solicitation of comments, 13 failed to pass the review

On February 3, 2021, the 40th batch of reference formulations for solicitation of comments, 9 failed to pass the review

On January 25, 2021, the 39th batch of reference formulations for solicitation of comments, 2 failed to pass the review

On January 5, 2021, the 38th batch of reference formulations for solicitation of comments, 9 failed to pass the review

On December 21, 2020, the 37th batch of reference formulations for solicitation of comments, 1 failed to pass the review

On December 21, 2020, the 36th batch of reference formulations for solicitation of comments, 1 failed to pass the review

On November 18, 2020, the 35th batch of reference formulations for solicitation of comments, 9 failed to pass the review

On September 07, 2020, the 34th batch of reference formulations for solicitation of comments, 1 failed to pass the review

On September 07, 2020, the 33rd batch of reference formulations for solicitation of comments, 5 failed to pass the review

On August 5, 2020, the 32nd batch of reference formulations for solicitation of comments, 8 of which were not passed after deliberation

On July 30, 2020, the 31st batch of reference formulation drafts for solicitation of comments, 20 of them failed to pass after review

On June 30, 2020, the 30th batch of reference formulation drafts for solicitation of comments, 9 of which failed to pass the review

On May 19, 2020, the 29th batch of reference formulation drafts for solicitation of comments, 4 of them failed to pass after deliberation

On January 10, 2020, the 26th batch of reference formulations for solicitation of comments, 22 of which were not passed after review

On January 10, 2020, the 26th batch of reference formulation drafts for solicitation of comments, 7 of which were not passed after deliberation

The main reasons for not passing the review:

The specification is unreasonable, which is less than the minimum dose recommended in the instruction manual for a single use

The original imported product of this variety has been released as a reference preparation, and the reference preparation applied by the enterprise is consistent with the published reference preparation concentration

This product is different from the domestic marketed varieties in loading volume, and is different from the domestic approved usage and dosage, and the administration is limited.

This product has no reference preparation status

Failure to provide complete and sufficient safety and effectiveness data

There are certain defects in related substances

Cause disease or clinical adverse reactions

There are safer drugs as reference preparations, etc.

The published reference preparation is a prescription drug on the market, and it is not recommended to add OTC drugs as a reference preparation

Compared with other oral preparations on the market, there is no clinical application advantage

There are safety risks in dosage, route of administration, etc.

This specification contains preservatives and has safety issues

Using sterile filtration process, domestic marketed varieties can withstand terminal sterilization

This product has been on the market earlier, with limited clinical safety and effectiveness data, and clinically better varieties have been substituted

It is a modified dosage form product of the published reference preparation, and the route of administration has not been changed, and there is no obvious clinical advantage

The molecular weight range is wide, and the amount of each component in the compound is not fixed

The reference preparation to be applied for is a generic drug marketed abroad (Japan, UK, etc.

The prescription of the proposed reference preparation contains bacteriostatic agents and antioxidants, and the safety data lack evidence support;

After receiving the objection application from the enterprise, it was reviewed by the Consistency Evaluation Expert Committee again, and the experts maintained the original conclusion, but the second review failed

For other details, please refer to the announcement of each reference preparation!

According to the "Announcement on the Selection and Determination Procedures for the Publication of Chemical Generic Drug Reference Preparations" issued by the National Bureau on March 28, 2019 (No.

During the period of publicity, please provide feedback to the Drug Evaluation Center through the "Suspicious Variety Application for Reference Preparation" module under the reference preparation selection application platform.

Announcement period: August 17, 2021 to August 30, 2021 (10 working days)

Drug Evaluation Center of the State Drug Administration

August 17, 2021