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GUANGDONGDETECTIONCENTEROFMICROBIOLOGY REPORT Name of Sample ApplicantANALYSIS2018FM13296R01DReport . FOREMOP Electrolysed water produced by EMOP electrolysis device Sihui Mai Tuo En
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New clinical applications refer to the processes through which new drug candidates, medical devices, or treatment protocols are submitted for regulatory review and approval to ensure they meet safety and efficacy standards.
Typically, new clinical applications must be filed by the sponsor of the clinical trial, which can be pharmaceutical companies, biotechnology firms, or research institutions responsible for developing the new treatment or product.
Filling out new clinical applications involves compiling comprehensive data on the product, including preclinical studies, clinical trial results, manufacturing details, proposed labeling, and information on the clinical research team, following guidelines from regulatory agencies.
The purpose of new clinical applications is to provide regulatory authorities with the necessary information to evaluate the safety and effectiveness of a new treatment or product to protect public health.
Information required includes data from preclinical studies, detailed clinical trial results, pharmacology information, manufacturing processes, proposed labeling, and risk assessment.
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