Pharmaceutical companies sued the State Food and Drug Administration to win!

Recently, China Judgment Document Network published an administrative judgment.

In the end, the pharmaceutical company won the case and the first-instance judgment is as follows:

According to Article 70, Item 3 and Article 79 of the "Administrative Procedure Law of the People's Republic of China", the judgment is as follows:

1.

2.

3.

Later, the State Food and Drug Administration refused to accept the judgment of the first instance and appealed to the Beijing Higher People's Court

Due to the length of the original judgment, the editor sorted out the case as follows:

▍One, the case

The drug involved is a new drug product jointly developed by the Four Medical Colleges, Shanghai Saida and Tahoe Biology

On February 5, 2018, the State Food and Drug Administration accepted the supplementary application submitted by Tahoe Biotech on January 30.

The reason is as follows: According to Article 15 of the current "Regulations on the Registration of Drug Technology Transfer" (implemented on August 19, 2009), when a drug technology is transferred, the transferor shall transfer all specifications of the transferred variety to the same transferee at one time Fang

Tahoe Biotech refused to accept the original decision and filed a review application with the State Food and Drug Administration.

On April 18, 2019, the State Food and Drug Administration accepted Tahoe's review application.

On November 25, 2019, the State Food and Drug Administration held a review meeting for the drug involved.

On February 14, 2020, the Center for Drug Evaluation received a reply letter from the Registration Department on the review of the drug involved in the case.

The Center for Drug Evaluation, in accordance with the reply letter of the Registration Department, recommended that the original review conclusion be maintained and the supplementary application for the drug involved in the case should not be approved

On February 19, 2020, the Center for Drug Evaluation completed the technical review and issued an review report

Tahoe Biotech refused to accept the decision of the sued reexamination and mailed an application for administrative reconsideration to the State Food and Drug Administration.

▍Second, the court held that:

This court believes that administrative actions taken by administrative agencies should comply with the administrative procedures established by laws, regulations, rules and other legal and effective normative documents

In this case, the defendant made a retrial decision.
Although it maintained the conclusion of the original trial decision, it changed the reason and basis of the original trial decision.
However, the evidence in the case could not prove that the Center for Drug Evaluation again heard the plaintiff and reviewed the reason and basis after the change.
Experts’ opinions, public demonstrations, and a final review opinion were formed on the principle of minority submission to majority.
Therefore, the defendant’s decision to be sued for review violated the above-mentioned legal procedures and should be revoked according to law
.
The accused reconsideration decision only confirms that the defendant’s decision to make the accused reexamination exceeds the legal time limit and is illegal and wrong, and this court shall revoke it at the same time
.

▍3.
The judgment of the first instance is as follows:

According to Article 70, Item 3 and Article 79 of the "Administrative Procedure Law of the People's Republic of China", the judgment is as follows:

1.
Withdraw the notice of approval opinion issued by the Defendant's State Drug Administration on February 20, 2020 with the batch number of 2020L02038;

2.
To revoke the administrative reconsideration decision made by the defendant State Drug Administration on June 8, 2020 on Yao Jian Fu Jue Zi [2020] No.
6;

3.
The defendant, the State Drug Administration, within the statutory period from the effective date of this judgment against the plaintiff Guangdong Taihe Bio-Pharmaceutical Co.
, Ltd.
, filed an application for re-examination of reorganized human tumor necrosis factor for injection
.

Later, the State Food and Drug Administration refused to accept the judgment of the first instance and appealed to the Beijing Higher People's Court
.
The judgment of the first instance was upheld in the second instance .