Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 87

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 87
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 each medical product. An application for marketing approval must be made through the PMDA. The PMDA reviews the results of the quality and nonclinical and clinical studies that show the efficacy and safety of the product candidate. A data compliance review, on-site inspection for good clinical practice, audit and detailed data review for compliance with cGMPs are undertaken by the PMDA. The application is then discussed by the committees of the Pharmaceutical Affairs and Food Sanitation Council. Based on the results of these reviews, the final decision on approval is made by the MHLW. 
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If the product is designed for treating certain difficult diseases and those for which the patient population is limited, the applicant may be able to obtain designation as an orphan drug product if it demonstrates unique therapeutic value. There are also expedited programs.
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The sponsor must complete a pre-clinical safety evaluation of the investigative product and submit a clinical trial notification, including the clinical trial protocol, to the PMDA in advance of clinical trial initiation in Japan. If the authorities do not raise an issue or comment on the notification application within 14 or 30 days, the sponsor may proceed to conclude a clinical trial agreement with the site and commence the clinical trial. Any changes to the trial protocol or other information submitted must be cleared by the IRB and when protocol is changed substantially, the clinical trial notification needs to be resubmitted. 
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The data from clinical trials and other pertinent data, which must be attached for an application for marketing approval, must be obtained in compliance with the standards established by the MHLW, such as the ICH Good Clinical Practice Guideline and cGCPs stipulated by the ministerial ordinances of the MHLW. Medicines used in clinical trials must be manufactured in accordance with Japan’s cGMPs.
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If the sponsor of the clinical trial is not an entity within Japan, it must appoint a domestic entity to act as its agent and carry out obligations on the overseas sponsor’s behalf. The sponsor must hold a clinical trial insurance policy, and in accordance with industry practice, should establish a compensation policy for the injuries from the trial.

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Non-clinical studies performed to demonstrate the safety of new chemical or biological substance must be conducted in compliance with the principles of Japanese cGLPs, which reflect the Organization for Economic Co-operation and Development (“OECD”) requirements. Currently, Japan, the EU and U.K. have a mutual recognition agreement for cGLPs, and data generated compliant with EU