The foreign enterprise filed a lawsuit against the State Food and drug administration, winning the lawsuit (attach the judgment of the Supreme Court)

Source: on January 16, 2015, nearly 30% of the drug applications were "shot" in the approval process every year In 2014, for example, about 560 of the 1900 acceptance numbers of chemical drugs, traditional Chinese medicine and biological agents reviewed were not approved, and the final result of "shot" may be several years later In the hundreds of applications that are "shot" every year, since 2011, a pharmaceutical factory named velpharm in Vietnam has started a three-year litigation battle with the State Food and drug administration, from the Beijing middle court to the Beijing High Court, and finally to the Supreme Court Surprisingly, the Supreme Court overturned the previous judgment and the CFDA lost the lawsuit "Just because of a reason that is not related to drug safety, quality and effectiveness, our application was" shot "and no supplementary materials were informed I just want to change the way CFDA does things," said Bei Qingsheng, chairman of Vietnam pharmaceutical company, to the media such as first financial daily Under the background of fully implementing the spirit of the Fourth Plenary Session of the Central Committee and governing the country according to law, will the relevant functional departments of the government carry out administration according to law and enterprises safeguard their rights according to law become a new normal? The judgment case made by the Supreme People's court is of great significance to all Chinese pharmaceutical enterprises, the State Food and Drug Administration and other regulatory departments, and it is worth rethinking in the whole industry (Bio Valley bio Com) the following is the full text of the judgment administrative judgment of the Supreme People's Court of the people's Republic of China (2014) Xing Ti Zi No 27 applicant for retrial (plaintiff in the first instance, appellant in the second instance): Vietnam vellpharm Pharmaceutical Co., Ltd Legal representative: Bei Qingsheng, general manager Entrusted agent: Guan Jingbo, an employee of the company Entrusted agent: Wang Zuzhi, employee of the company Respondent (defendant in the first instance and appellee in the second instance): State Food and Drug Administration of the people's Republic of China (formerly state food and Drug Administration of the people's Republic of China) Legal representative: Zhang Yong, director general Entrusted agent: Dong Jiangping, director of the Chemical Department of the drug and cosmetic registration department of the Bureau Entrusted agent: Li Jiang, lawyer of Beijing zhongzhao law firm Vietnam vellpharm Pharmaceutical Co., Ltd (hereinafter referred to as "vellpharm company") v state food and Drug Administration of the people's Republic of China (hereinafter referred to as "State Food and Drug Administration") drug administrative license case, Beijing Higher People's Court issued (2012) Gao Hang Zhong Zi No 90 on May 18, 2012 Administrative judgment No Vellpharm company was not satisfied and applied to the court for retrial On June 30, 2014, the court made an administrative ruling (2012) XJZ No 633 to bring the case to trial In accordance with the law, a collegial panel composed of judge Wang Xiaobin as the presiding judge and acting as judges Yan Wei and Tong Lei participated was formed On September 29, 2014, the case was heard in public The legal representatives of vellpharm company, Bei Qingsheng, entrusted agents, Guan Jingbo and Wang Zuzhi, and the entrusted agents, Dong Jiangping and Li Jiang, from the State Food and Drug Administration of the people's Republic of China, attended the court proceedings The case has now been concluded After retrial, it was found that vellpharm company applied to the State Food and Drug Administration on April 15, 2009 for clinical trial registration of imported felodipine controlled-release tablets, and the State Food and Drug Administration accepted and notified the payment and drug registration inspection on April 20, 2009 Vellpharm company has carried out payment, data submission and sample inspection On April 30, 2009, the General Administration of food and drug of the people's Republic of China transferred the relevant application materials to the drug review center, which transferred the comprehensive review opinions to the General Administration of food and drug of the people's Republic of China on February 9, 2010 On August 9, 2010, the General Administration of food and drug of the people's Republic of China returned the opinions to the drug review center for further review, which was on November 12, 2010 On the same day, after the comprehensive review opinion was made again, the State Food and Drug Administration decided not to approve the registration (Clinical Research) of vellpharm company's above application (approval No.: 2010l04265) The reasons are as follows: the API used in the imported preparation shall be provided with the supporting documents issued by the national drug administration to allow the API to be marketed and sold, as well as the supporting documents issued by the pharmaceutical manufacturer to meet the pharmaceutical production quality management specifications The API used in this product comes from the pharmaceutical factory of Zhejiang Juhua Group Co., Ltd., which has no approval number of API, and the application materials do not provide the research data such as the synthesis process, structure confirmation, quality research and stability research of the API and the supporting documents that the manufacturer meets the drug quality management specifications According to Article 95 of the measures for the administration of drug registration and Article 4 of point 6 (2) of Annex 2, the application for registration of felodipine controlled-release tablets is not approved Vellpharm company is not satisfied with this, and filed an administrative lawsuit in the court of first instance It is also found that the "Article 6 (2) (4)" quoted in the notice of approval opinions should be accurately described as "Article 6 (2) (4) of Annex 2" It was found out again that on November 17, 2010, China Institute of pharmaceutical and biological product control issued the drug registration and inspection report (zjy (2010) No 1922) According to the first instance of the first intermediate people's Court of Beijing, according to the drug administration law of the people's Republic of China, the drug regulatory department under the State Council is in charge of the National Drug Administration Article 5 of the measures for the administration of drug registration stipulates that the State Food and drug administration is in charge of the national drug registration and is responsible for the examination and approval of drug clinical trials, drug production and import Therefore, the defendant has the legal duty to approve the clinical research application of felodipine controlled-release tablets proposed by the plaintiff The focus of the dispute in this case is: 1 Whether the defendant made the notice of examination and approval opinions is illegal; 2 Whether the notice of examination and approval opinions has facts and legal basis As for focus 1, the plaintiff raised three disputes, that is, the defendant did not inform it that the procedure of supplementary application materials was illegal; the notice of examination and approval opinions was not stamped with the defendant's seal; and the time for making the notice of examination and approval opinions exceeded the legal period of administrative permission Article 91 of the measures for the administration of drug registration stipulates that the drug evaluation center of the State Food and drug administration shall organize pharmaceutical, medical and other technical personnel to evaluate the application materials within the specified time, and may require the applicant to supplement the materials and state the reasons if necessary The provisions of this article refer to the administrative procedures performed by the defendant according to the needs of the examination when the defendant conducts substantive examination of the application materials, which is not the legal necessary procedure for the defendant to conduct drug examination and approval Therefore, the plaintiff's claim that the defendant didn't notify or require the defendant to supplement the missing materials is against the legal procedure and lacks the facts and legal basis, so the court of first instance does not support it "Special seal for drug registration of State Food and Drug Administration" is affixed to the notice of approval opinions, which belongs to the special seal for drug registration and approval of the defendant, and the seal used by the defendant is not improper The court of first instance does not support the plaintiff's claim that the use of seal is illegal According to the provisions of Article 42 of the administrative license law, in addition to making a decision on administrative license on the spot, the administrative organ shall make a decision on administrative license within 20 days from the date of accepting the application for administrative license If a decision cannot be made within 20 days, it may be extended for 10 days with the approval of the person in charge of the administrative organ, and the applicant shall be informed of the reasons for the extension According to Article 45 of the administrative license law, if an administrative organ needs hearing, bidding, auction, inspection, quarantine, appraisal and expert review when making a decision on administrative license according to law, the time required shall not be calculated within the time limit specified in this section The case was accepted on April 20, 2009 and transferred to the defendant drug review center for review on April 30, 2009 The review ended on November 12, 2010, and ended on November 12, 2010 According to Article 45 of the administrative license law, the defendant made the notice of examination and approval opinions every day The time of making the notice of examination and approval opinions in this case is in line with the provisions of the administrative license law Therefore, the plaintiff believes that the defendant's claim that the time of making the administrative license is illegal is not supported by the court of first instance With regard to focus 2, Article 95 of the measures for the administration of drug registration stipulates: "when applying for the import of pharmaceutical preparations, it is necessary to provide the certification documents of the legal sources of the packaging materials and containers directly contacting the drugs, and the certification documents of the legal sources of the raw materials and auxiliary materials used for the production of the preparations Where the APIs and excipients have not yet been approved by the State Food and drug administration, the research data on the production process, quality indicators, inspection methods and other specifications shall be submitted " In this case, the drugs involved in the registration applied by the plaintiff came from Vietnam The plaintiff applying for the registration of the imported drugs in China shall comply with the provisions of Article 95 of the measures for the administration of drug registration concerning the APIs in imported preparations, so as to meet the needs of the evaluation of drug safety, effectiveness and quality controllability The plaintiff submitted the relevant materials for the listing of APIs in Vietnam as the examination basis for the import registration of the drugs involved in the case in China, which did not meet the above provisions Through the examination of the application materials submitted by the plaintiff to the defendant and in combination with the above provisions, the court recognized the specific reasons why the defendant did not approve the import registration of the drugs involved in the case in the notice of examination and approval opinions The court of first instance does not support the plaintiff's lack of facts and legal basis To sum up, the fact that the defendant made the notice of examination and approval opinions is clear, the evidence is sufficient, and the applicable law is correct The plaintiff requests the court to cancel the notice of examination and approval opinions and order the defendant to make a decision again The court of first instance does not support it According to the provisions of item (4) of Article 56 of the interpretation of the Supreme People's Court on the implementation of administrative procedure law of the people's Republic of China, the judgment is as follows: the lawsuit request of the plaintiff Vietnam vellpharm Pharmaceutical Co., Ltd is rejected According to the second instance of the Beijing Higher People's court, according to Article 29 of the drug administration law, when developing new drugs, it is necessary to truthfully submit relevant materials and samples such as research methods, quality indicators, pharmacological and toxicological test results in accordance with the provisions of the drug regulatory department under the state Council, and carry out clinical trials only after the approval of the drug regulatory department under the State Council Article 29 of the regulations for the implementation of the drug administration law stipulates that the clinical trials, production and import of drugs shall conform to the provisions of the drug administration law and these regulations and be examined and approved by the drug regulatory department under the State Council Therefore, SFDA has the legal authority to make the notice of the examination and approval opinions of this case With reference to Article 91 of the measures for the administration of drug registration, the drug evaluation center shall organize pharmaceutical, medical and other technical personnel to evaluate the application materials within the specified time, and may require the applicant to supplement the materials and explain the reasons if necessary With reference to the provisions of Article 92 of the measures for the administration of drug registration, the drug evaluation center shall form comprehensive opinions based on the technical evaluation opinions and sample inspection results, and the State Food and drug administration shall make the approval decision based on the comprehensive opinions Compliant