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Investigational medicinal product dossier

An Investigational Medicinal Product Dossier (IMPD) is intended to be more comprehensive than an IB, in that it should contain summaries of available quality data in addition to the safety and efficacy information that constitutes the main part of the IB. In total, it should provide information on the chemistry, manufacture, control and stability ofthe medicinal product, together with the results of non-clinical and clinical studies. In order to avoid repetition, the IB can be cross-referenced for non-clinical and clinical results. Ideally, the IMPD should follow the same structure as that which will be used later for the marketing authorisation application. For products with existing marketing authorisations, the Summary of Product Characteristics may replace the IMPD to varying extents (see Chapter 6). [Pg.82]

The application for a clinical trial authorisation (CTA) for the first administration of a NME to man comprises the same elements as all other CTAs but, of course, there will be no clinical data. The regulatory authority known as the competent authority (CA) of the EU member state requires receipt of confirmation of the EU clinical trials database (EUDRACT) number, a covering letter, a completed application form, the protocol with all current amendments, the IB and a full Investigational Medicinal Product Dossier (IMPD) (see below). If the study is to be conducted in more than one member state, a list of CAs should be included. If the opinion of the lEC is available, it should be provided. [Pg.153]

Detailed guidance on the preparation of the Investigational Medicinal Product Dossier is available [11], In terms of preclinical aspects, the key considerations are ... [Pg.77]

The investigational medicinal product dossier can be stand-alone or be constructed by cross-reference to relevant sections of the IB (applies to preclinical and clinical data only). [Pg.77]

The regulatory procedure involved is a so-called Clinical Trial Authorization appH-cation (CTA) and consists, in addition to a Clinical Trial Protocol (CTP) and Investigator s Brochure (IB), of an Investigational Medicinal Product Dossier (IMPD) in CTD format. The IMPD consists of quality data, nonclinical pharmacology and toxicology data, clinical trial and previous human experience data, and an overall risk-benefit assessment. A copy of the CTA is sent to each EU Member State where the study is conducted, as well as to the Ethics Committees for approval. These also have to be notified in case of any amendments, study termination and adverse reactions. The contents of the IMPD are case specific and may be simplified or even replaced by the... [Pg.1697]

For agents for clinical trials, an Investigational Medicinal Product Dossier (IMPD) is required [8], see also Sects. 3.4 and 35.5.10. In the IMPD, the production and quality of both the raw materials and the products is described. Furthermore, all known data from preclinical and clinical research is summarised in this document. [Pg.354]


See other pages where Investigational medicinal product dossier is mentioned: [Pg.82]    [Pg.86]    [Pg.77]    [Pg.355]    [Pg.1672]    [Pg.1863]    [Pg.781]    [Pg.892]    [Pg.562]    [Pg.82]    [Pg.86]    [Pg.77]    [Pg.355]    [Pg.1672]    [Pg.1863]    [Pg.781]    [Pg.892]    [Pg.562]    [Pg.36]    [Pg.504]   
See also in sourсe #XX -- [ Pg.153 ]




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