Not to accept the findings of the review enterprises will be the State Drug Administration to court.

Wuhan San Ai High-tech Development Co., Ltd. (hereinafter referred to as Wuhan San Ai Company) said that "the drug review center abused the right to review and approve, do not approve the ice jade hydrant that meets the statutory conditions, resulting in direct economic losses of enterprises more than 5 million yuan."
" According to the information disclosed in the judgment, the prescription and adaptation of the application for "Ice Jade Cleaner": The prescription of this product consists of ice flakes, borax (calcin), xuanming powder, pearls.
is chronic cervicitis cervical erosion, Chinese medicine dialectical is wet hot betting evidence.
Love Enterprise Survey website shows that Wuhan Saint Love High-tech Development Co., Ltd. was established on January 10, 2002, registered in Hongshan Guandong Science and Technology Park East Lake High-tech Cyberport, the legal representative is Liang Liwei.
business scope includes Chinese and Western medicine, new drug research and development.
(projects that are subject to approval according to law and may be carried out business activities only after approval by relevant departments) Clinical data "questionable validity" Drug Review Center made a non-approval in August 2014, the Drug Review Center completed the technical review of the drug, concluding that "does not comply with the relevant provisions of drug approval, does not approve the new drug certificate of this product."
reasons are: This product is a compound preparation of Chinese medicine, has completed phase II., III. clinical research, apply for a new drug certificate.
to choose chronic cervicitis cervical erosion, Chinese medicine dialectical is wet hot betting evidence.
clinical trials of this product to cervical erosion surface changes, Chinese medicine certificate points as the main indicators.
At present, the medical community's understanding of "cervical erosion" has changed greatly, "cervical erosion" is no longer diagnosed as a disease, cervical erosion surface changes should no longer be used as (main) efficacy indicators.
And for the chinese medicine certificate after the points and symptom improvement, the clinical trial of this product, there are included cases of cervical erosion degree, inflammation degree, vaginal cleanliness are light, when the baseline detection data in the group is not unified in the menstrual cycle of the same point in time, the reporting information can not support the evaluation of its clinical effectiveness.
shall not be approved in accordance with article 154, paragraph 3, of the Measures for the Administration of Drug Registration.
application for review in December 2014, and in October 2016, the Drug Review Center issued a review opinion, upholding the findings of the 2014 review.
reasons are: This product is a compound preparation of Chinese medicine, has completed phase II., III. clinical research, apply for a new drug certificate.
to choose chronic cervicitis cervical erosion, Chinese medicine dialectical is wet hot betting evidence.
Baseline test data were not collected uniformly at the same point in the menstrual cycle when the clinical trials of this product were added, because the under-band conditions in the main efficacy indicators "rotten area" and "Chinese medicine certificate efficacy" will change periodically with the menstrual cycle, thus seriously affecting the evaluation basis of the main efficacy indicators.
Clinical trials of this product, there are also cases of cervical erosion, inflammation, vaginal cleanliness are light problems, resulting in more than half of the subjects lack the significance of drug treatment, while no placebo control design, it is more difficult to explain the effectiveness of this product.
, project design and implementation do not support the evaluation of its clinical effectiveness.
shall not be approved in accordance with article 154, paragraph 3, of the Measures for the Administration of Drug Registration.
from the above reasons, it can be seen that the review opinion does not refer to "the adaptation of the enterprise application" cervical erosion, no longer diagnosed as a disease" as a reason for non-approval.
focus on clinical trials, clinical data do not indicate the effectiveness of drugs.
enterprises do not accept, all the way to complain according to the public judgment, dandelion small editor combed out the drug review, enterprise appeal process.
, April 1, 2012, the enterprise applied for a new drug certificate of ice jade hydrant application 2, August 2014, the drug review center completed the technical review of the drug, concluded that "does not comply with the relevant provisions of drug approval, do not approve the new drug certificate."
3, 2014, the enterprise applied for review, and in October 2016, the Drug Review Center completed a technical review, the review opinion is: in accordance with the Drug Administration Law and relevant provisions, after review, to maintain the original approval conclusions.
4, March 3, 2017, the enterprise applied for administrative review, requiring: 1, re-decision to approve the new drug certificate of ice jade hydrant;
2017, the enterprise filed an administrative lawsuit (first instance) with the Beijing No. 1 Intermediate People's Court, and in December 2017, the court rejected the enterprise's claim after hearing the case.
June 2018, enterprises appealed to the Beijing Higher People's Court (the second instance) against the administrative decision of the first instance, and in June 2018, the court rejected the appeal and upheld the first instance judgment.
July and 2019, the enterprise applied to the Supreme People's Court of the People's Republic of China for a retrial against the administrative judgment of the second instance, and in June 2020, the court rejected the enterprise's application for retrial after hearing it.
1, the enterprise applied for review On December 11, 2014, Wuhan Sacred Love Company applied for review.
the General Administration of Food and Drug Administration on the same month, 23 began the technical review of the review, and after the review of professional meetings, review meetings, proactive consultations and other procedures.
Among them, on September 1, 2016, the active consultation, the participants included representatives of Wuhan Sacred Love Company, the communication questions are as follows: First, "This product chooses 'chronic cervicitis cervical erosion (wet hot bet certificate)', for the adaptation, to 'cervical erosion surface change' as the main therapeutic indicators of the rationality of the problem."
"Second, " clinical trials of this product include cases of cervical erosion, inflammation, vaginal cleanliness of the problem.
the problem of "third," the baseline data of this product is not uniformly collected at the same point in the menstrual cycle.
" Wuhan Sacred Love Company on the above-mentioned issues are commented on.
October 2016, the Drug Review Centre completed a technical review, which concluded that "after review, the original review conclusions were maintained and the original conclusions were recommended to be maintained".
2, enterprises apply for administrative review On March 3, 2017, Wuhan Sacred Love Company applied for administrative reconsideration, request: 1. Revocation of approval document No. 2014L01801 and review document No. 2016L10191, and re-decision on the approval of the new drug certificate for ice jade hydrant; Compensation for the loss of Wuhan Sacred Love Company; 3. Open the review criteria for the treatment of cervical erosion of chronic cervicitis, and make public the review report of the same adaptive variety of latex gel.
among them, the application for administrative review on the "specific compensation request" records: "Drug review center abuse of the right to review and review approval, do not approve the compliance with the statutory conditions of ice jade hydrant, resulting in direct economic losses of enterprises more than 5 million yuan."
" General Administration of Food and Drug Administration made the 11th reconsideration decision (follow-up first instance, second instance, retrial focus) On May 12, 2017, the General Administration of Food and Drug Administration made the decision on the review of the drug supervision (2017) No. 11 administrative review decision (hereinafter referred to as the 11th reconsideration decision), this decision, the enterprise follow-up to the court first instance, second instance have requested the revocation of the "11th review decision."
▍ The main contents of the decision: Wuhan Sacred Love Company for the 2014L01801 approval of the administrative review application exceeded the legal deadline of 60 days, should be rejected in accordance with the law;
of Food and Drug Administration of The State Administration of Food and Drug Administration has made the 2016L10191 review on the basis of the review technical review opinion, which has sufficient factual and legal basis.
Administration of Food and Drug Administration accepted the application for review of Wuhan Sacred Love Company on December 16, 2014, net of 150 days during the technical review period and 50 days of approval, the review time exceeded the statutory time limit; The overdue approval of the General Administration of Food and Drug Administration did not have any material impact on the approval conclusions, nor did it cause any losses to Wuhan Sacred Love Company, Wuhan Sacred Love Company requested administrative compensation, lack of facts and legal basis;
3, the court first instance, second instance, retrial▍ First instance 2017, Wuhan Sacred Love Company did not accept the administrative proceedings filed in this case, to the Beijing No. 1 Intermediate People's Court to file administrative proceedings (first instance), requesting the revocation of the 11th reconsideration decision, ordered the General Administration of Food and Drug To make a reconsideration decision.
Beijing No. 1 Intermediate People's Court (2017) Beijing 01 Early 1151 Administrative Judgment held that Wuhan Sacred Love Company requested the revocation of the 2014L01801 approval, but the General Administration of Food and Drug Administration has made 2016L1 Review No. 0191, 2014L01801 approval at this time is essentially the General Administration of Food and Drug Administration on the application of Wuhan San Ai Company made an intermediate processing decision, does not fall within the scope of administrative review, the General Administration of Food and Drug Administration rejected the request for reconsideration, the conclusion is not improper.
but the 11th reconsideration decision found that Wuhan Sacred Love Company's request for reconsideration exceeded the statutory deadline is wrong, to be corrected.
The General Administration of Food and Drug Administration made the 2016L10191 review document on the technical basis of the comprehensive review opinion, which has the facts and legal basis, and the General Administration of Food and Drug Administration in the process of making the 2016L10191 review document, also fully listened to the statement and defense of Wuhan Sacred Love Company.
The General Administration of Food and Drug Administration accepted the application of Wuhan Sacred Love Company on December 16, 2014 and made a review document No. 2016L10191 on November 18, 2016, net of The technical review time of 150 days has exceeded the period of administrative license stipulated in the Administrative Licensing Law, because the over-time violation of the law caused damage to the legal rights of the Wuhan Sacred Love Company entity, the 11th reconsideration decision confirmed that the procedure of the act is illegal and not improper.
Wuhan Sacred Love Company's claim for compensation for the loss is the cost of its research and development of the drugs involved in the case, and the General Administration of Food and Drug Administration over-approval of illegal acts is not necessarily linked, the General Administration of Food and Drug Administration rejected the request for reconsideration, in accordance with the law.
Wuhan Sacred Love Company requested the disclosure of the standards for drug review of cervical erosion treatment of chronic cervicitis and the review report of latex gel, but the request for reconsideration did not fall within the scope of administrative review, and the General Administration of Food and Drug Administration rejected its request for reconsideration, nor was it improper.
in accordance with the provisions of Article 69 of the Administrative Procedure Law of the People's Republic of China, the judgment rejected wuhan Sacred Love Company's claim.
▍ In 2018, the enterprise appealed to the Beijing Higher People's Court against the administrative decision of the first instance (second instance), and in June 2018, the Beijing Higher People's Court (2018) Beijing Bank's final administrative judgment No. 1836 held that the first instance judgment rejected the lawsuit of Wuhan Sacred Love Company was not improper, and the grounds and claims of Wuhan Sacred Love Company lacked facts and legal basis.
, in accordance with the provisions of Article 89 (1) (1) of the Administrative Procedure Law of the People's Republic of China, the judgment rejects the appeal and upholds the first instance judgment.
▍ in 2019, enterprises will apply to the Supreme People's Court of the People's Republic of China for retrial against the administrative judgment of the second instance.
june 2020, the court heard the ruling.
court held that the decision of the Food and Drug Administration was not improper with regard to the withdrawal of the Reconsideration Decision No. 11 by the enterprise.
As for Wuhan Sacred Love Company's request for reconsideration of its 5 million yuan research and development expenses, there is no causal relationship between the violation of the 2016 L10191 review procedure and the loss of 5 million yuan of research and development expenses of Wuhan St. Love Company, and the 11th reconsideration decision rejected the request, nor is it improper.
The Wuhan Sacred Love Company maintains that the General Administration of Food and Drug Administration has twice abused its power to falsify evidence, fabricate facts, have no legal basis and make two decisions not to grant permission in violation of due process.
However, the decision of the General Administration of Food and Drug Administration not to grant permission was based on the results of two technical reviews and the full extraction of the opinion of Wuhan Sacred Love Company in administrative proceedings, which was not supported by evidence, on the grounds that the application for retrial could not be established.
, Wuhan Sacred Love Company also advocated that the first and second trials did not have the main evidence of dissent to organize the trial of evidence, the procedure is illegal, may affect a fair trial.
, according to the first and second instance of the case, the people's court has fully guaranteed its right to litigation, and its claim is inconsistent with the facts of the case.
to apply for a retrial on this ground, and the reasons cannot be established.
: reject the retrial applicant Wuhan St. Ai High-tech Development Co., Ltd. retrial application.
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