@@ -198,6 +198,20 @@ In China, projects that meet the following criteria are eligible to apply for an
<p>
After completing the pre-clinical trials, another choice is to apply for an investigator-initiated clinical trials (IIT) to provide treatment to patients on a non-profit basis. The experimental process of IIT is similar to that of pharmaceutical company-initiated trials, but the aim is to advance clinical research or explore new treatment options rather than directly bringing the drug to market.
</p>
<p>
In China, there is no need to submit the IIT directly to the National Medical Products Administration (NMPA) for approval, as IITs are considered non-commercial trials. The researcher initiates the trial with the hospital or institution where the trial will be conducted, it will be reviewed by the clinical research center and approved by the ethics committee before conducting. The simplified timeline of a Chinese IIT application is shown in Figure 4.
</p>
<p>
In China, applying for IIT generally requires meeting the following conditions:
</p>
<ul>
<li><b>Researcher Qualifications:</b> The principal investigator must have relevant medical or scientific qualifications and typically work at a qualified medical institution, such as a tertiary hospital or an accredited research organization.</li>
<li><b>Study Protocol:</b> A complete study protocol must be provided, outlining the objectives, methods, inclusion criteria for participants, expected outcomes, and data analysis plan. The protocol must comply with scientific and ethical standards.</li>
<li><b>Non-commercial Nature:</b> IITs are conducted for research purposes, not for commercialization. The drugs or therapies used in the study should not be intended for profit.</li>
<li><b>Study Materials:</b> Any drugs, devices, or treatments used in the trial must comply with national regulations, and detailed production and quality control information must be provided.</li>
<figcaptionstyle="width:60vh"> Fig.4 The timeline of a Chinese IIT application</figcaption>
</div>
...
...
@@ -206,24 +220,26 @@ In China, projects that meet the following criteria are eligible to apply for an
</div>
<divclass="block">
<p>
After accomplishing Phase III Clinical Trial, we can Submit a New Drug Application(NDA) to the National Medical Products Administration (NMPA).
After accomplishing Phase III Clinical Trial, we can Submit a New Drug Application(NDA) to the National Medical Products Administration (NMPA). The timeline of market authorization in China is shown in Figure 5.
</p>
<p>The New Drug Application (NDA) process in China involves several key steps:
<ul>
<li>Preparation of NDA Documents: Compile all necessary documents, including data from preclinical studies, clinical trial results, manufacturing processes, and proposed labeling. This includes safety and efficacy data from all phases of clinical trials.</li>
<li>Submission to the National Medical Products Administration (NMPA): Submit the NDA to the NMPA, which includes detailed information about the drug's development, clinical trial data, proposed indications, and any relevant pharmacological and toxicological information.</li>
<li>Acceptance Review: The NMPA conducts an initial acceptance review to ensure that the application is complete and complies with regulatory requirements. If accepted, the review process begins.</li>
<li>Technical Review: A comprehensive evaluation is performed by expert committees. This includes assessing the safety, efficacy, quality, and labeling of the drug. Additional information or clarifications may be requested during this phase.</li>
<li>Inspection: The NMPA may conduct inspections of the manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP).</li>
<li>Approval Decision: Based on the technical review and inspections, the NMPA makes a decision. If approved, the drug receives a marketing authorization, allowing it to be sold in the Chinese market.</li>
<li>Post-Marketing Surveillance: After approval, the drug is subject to post-marketing surveillance to monitor its safety and efficacy in the general population.</li>
<li><b>Preparation of NDA Documents:</b> Compile all necessary documents, including data from preclinical studies, clinical trial results, manufacturing processes, and proposed labeling. This includes safety and efficacy data from all phases of clinical trials.</li>
<li><b> Submission to the Center for Drug Evaluation (CDE): </b>Submit the NDA to the CDE, which includes detailed information about the drug's development, clinical trial data, proposed indications, and any relevant pharmacological and toxicological information.</li>
<li><b>Formal Review:</b> After submission, the Center for Drug Evaluation (CDE) conducts a formal review to ensure that the application contains all the necessary information and meets the required standards for further evaluation.</li>
<li><b>Technical Review:</b> In this phase, a detailed technical review is conducted by experts to evaluate the safety, efficacy, and quality of the drug. This includes reviewing clinical trial data, manufacturing processes, and other relevant information.</li>
<li><b>Registration inspection:</b>This step involves inspecting the manufacturing site to ensure that the production process complies with Good Manufacturing Practices (GMP) and that the facility meets the required standards for drug production.</li>
<li><b>Expert review:</b>A team of experts conducts a detailed review of the scientific, clinical, and technical data submitted by the applicant. This review assesses the safety, efficacy, and quality of the drug.</li>
<li><b>Registration verification: </b>This step involves verifying that the submitted data and documentation are accurate and meet the regulatory standards for drug approval. It ensures that all aspects of the drug development and production process are compliant.</li>
<li><b>Three-in-one review:</b>The Business Management Department of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) integrates the production site inspection report, the on-site sampling and testing report, and the technical review report for comprehensive evaluation.</li>
