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A ship in port is safe, but that's not what ships are built for.在港口的船多安全，但船不是建來停在港口用的。
– Grace Hopper
Regulatory Authority 監管機構
Per the DRR, the NMPA-No50-2018, the NMPA includes the National Institutes for Food and Drug Control (NIFDC) and the CDE, which are directly involved in the clinical trial application and drug registration approval process. Other relevant institutes and organizations include the National Pharmacopoeia Commission, the Food and Drug Inspection Center, the Medical Device Technology Evaluation Center, the Administration Service Center, the Information Center, the Licensed Pharmacist Certification Center, the News and Publicity Center, and the International Exchange Center. 根據《藥品註冊管理辦法》、2018第50號令，NMPA包括直接參與臨床試驗申請和藥品註冊批准過程的國家食品藥品檢定研究院(NIFDC)和藥品審評中心(CDE)。其他相關單位和組織包括國家藥典委員會、食品藥品檢驗中心、醫療器械技術審評中心、行政服務中心、信息中心、執業藥師認證中心、新聞宣傳中心、國際交流中心。Further, the DRR delineates the responsibilities of the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government. With respect to clinical trials, they are responsible for organizing the daily supervision and investigation of drug clinical trial institutions; participating in drug registration verification and inspection organized by NMPA; and other matters entrusted by the NMPA.
此外，《藥品註冊管理辦法》、規定了省、自治區、直轄市藥品監督管理部門的職責。臨床試驗方面，負責組織藥物臨床試驗機構的日常監督檢查；參加國家藥品監督管理局組織的藥品註冊核查檢查；以及國家藥品監督管理局委託的其他事項。As per the FD&CAct, 21CFR50, and 21CFR312, the Food & Drug Administration (FDA) is the regulatory authority that regulates clinical investigations of medical products in the United States (US). This profile is specifically focused on the FDA’s role in reviewing and authorizing investigational new drug applications (INDs) to conduct clinical trials using investigational drug or biological products in humans in accordance with the FD&CAct, 21CFR50, and 21CFR312. Regulatory requirements relating to compliance with federally funded or sponsored human subjects research protections, known as the Common Rule, which the Department of Health & Human Services (HHS) implements in subpart A of 45CFR46, are also examined. 根據《食品藥品和化妝品法案》、21CFR50和21CFR312，美國食品藥品監督管理局(FDA)是監管醫療產品臨床研究的監管機構。FDA根據《食品藥品和化妝品法案》、21CFR50和21CFR312審查和授權試驗性新藥申請(IND)在人體中使用試驗藥物或生物製品進行臨床試驗，還審查了與聯邦資助或申辦的人類受試者研究保護（稱為共同規則）合規性相關的監管要求，衛生和公共服務部(HHS)在45CFR46的A部分中實施。Per the DRR, the registration of drugs must be classified and managed in accordance with three broad categories of Chinese medicines, chemical medicines, and biological products. 根據藥品註冊管理辦法，藥品註冊必須按照中藥、化學藥品和生物製品三大類進行分類和管理。The scope of the NMPA’s assessment includes Phase I through Phase IV clinical trials and bioequivalence studies. NMPA評估的範圍包括I期至IV期臨床試驗和生物等效性研究。
The DRR emphasizes a risk-based approach to drug registration and clinical trial approvals, following the principles of openness, fairness, and justice. This is guided by demonstrating clinical value, encouraging research and creation of new drugs, and promoting the development of generic drugs.藥品註冊管理辦法強調基於風險的藥物註冊和臨床試驗批准方法，遵循公開、公平和公正的原則。以證明臨床價值、鼓勵新藥研發、促進仿製藥開發為指導。
According to 21CFR Part 312, the FDA categorizes INDs as either commercial or non-commercial (research) and classifies them into the following types: Investigator INDs, Emergency Use INDs, Treatment INDs. 根據21CFR312，FDA將IND分為商業化或非商業化（研究），並將其分為以下類型：研究者發起IND、緊急使用IND、治療使用IND。As indicated in the G-IND-Determination, in general, human research studies must be conducted under an IND if all of the following research conditions apply:
如G-IND-Determination所示，一般來說，如果以下所有研究條件均適用，則人體研究必須在開啟IND後進行：- A drug is involved as defined in the FD&C Act - A clinical investigation is being conducted as defined in 21CFR312 - The clinical investigation is not otherwise exempt from 21CFR312Further, per 21CFR312 , whether an IND is required to conduct an investigation of a marketed drug primarily depends on the intent of the investigation and the degree of risk associated with the use of the drug in the investigation.
此外，根據21CFR312，是否需要對已上市藥物進行研究進行IND，主要取決於研究的目的和與研究中使用該藥物相關的風險程度。In accordance with the DRR, the applicant is required to pay a fee per applicable regulations. As per the NMPA-No75-2020, NMPA-No53-2015, the National Medical Products Administration (NMPA) charges the following drug registration fees to review and approve clinical trials as part of the drug registration process:
根據《藥品註冊管理辦法》，要求申請人根據適用法規支付費用。根據2020第75號令、2015第53號令，國家藥品監督管理局收取以下藥品註冊費，用於審批臨床試驗，作為藥品註冊過程的一部分：New drugs made in China: 192,000 RMB New drugs made outside of China: 376,000 RMBGeneric drugs made in China: 318,000 RMBGeneric drugs made outside of China: 502,000 RMB境外仿製藥：50.2萬元
The Food & Drug Administration (FDA) does not levy a fee to review investigational new drug (IND) submissions.美國食品藥品監督管理局(FDA)不收取審查試驗性新藥(IND)申報資料的費用。However, per the FD&CAct, the FDA has the authority to assess and collect user fees from companies that produce certain human drug and biological products as part of the New Drug Application (NDA). NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States (US).
然而，根據《食品藥品和化妝品法案》、FDA有權評估和收取生產某些人用藥品和生物製品的公司的使用費用，作為新藥申請（NDA, 藥物申辦者正式申請FDA批准一種新藥在美國銷售和上市）的一部分。 Get in touch and meet our team!創建於瑞士；專家顧問團隊布局德國、美國、中國，在醫藥行業或國際監管機構組織有平均20年的多元專業領域經驗；擅長臨床研發到商業化的GxP全過程戰略構建、技術諮詢與互動式培訓，致力為國內外醫藥生技公司定製合規國際標準的質量及風險體系，並助力推動跨部門高效實踐