TAILIEUCHUNG - Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials

During the past decade, there has been a marked rise in the living standards of the Chinese people. The yearly growth of consumption per capita has been about 15%, and annual average growth in the savings deposit balances of residents have been over 50% since 1978. The five provinces or cities with the highest per capita consumption are Shanghai, Beijing, Tianjin, Guangdong, and Zhejiang, while the five provinces with the highest total personal consumption are Sichuan, Guangdong, Shandong, Jiangsu, and Liaoning. Since the Chinese government readjusted the allocation of resources, stimulating more consumption and less capital. | EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Guidance on Investigational Medicinal Products IMPs and other medicinal products used in Clinical Trials To be included in The rules governing medicinal products in the European Union Volume 10 Clinical Trials Notice to Applicants Chapter V Additional Information 1 1. Introduction To facilitate the conduct of clinical trials in the member States of the European Union especially multi-centre clinical trials carried out in more than one member State it is necessary to have a common understanding of the definition of an investigational medicinal product. This document intends to clarify and provide additional guidance on the definition of investigational medicinal products and to provide specific guidance about the use of non-investigational medicinal products in accordance with the applicable EU legislation. This document complements the Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities notification of substantial amendments and declaration of the end of the trial 1 and the Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use .2 2. Investigational Medicinal Products IMP The definition of an investigational medicinal product IMP is provided in Directive 2001 20 EC Article 2 d as a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial including products already with a marketing authorization but used or assembled formulated or packaged in a way different from the authorised form or when used for an unauthorised indication or when used to gain further information about the authorised form. Medicinal products with a marketing authorisation MA are classified as IMPs when they are to be used as the test .

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