Dossier, drug

Gursoy, R. N., and Benita, S. (2004), Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs, Biomed. Pharmacother. Dossier Drug Deliv. Drug Efficacy, 58,173-182. 

The dossier submitted to the CDER is known as a new drug application (NDA), which, if approved, allows the drug to be marketed. If the drug is a CBER-regulated one, then a biologies licence application (BLA) is submitted. 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

The PAB undertakes drug dossier evaluations, a process that normally takes 18 months. The approval requirements/process for pharmaceuticals (including biopharmaceuticals) are, in broad terms, quite similar to the USA. The PAB have issued specific requirements (Notification 243) for submission of recombinant protein drugs. 

Phase Ilia. Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug Application (NDA) or other dossier. These clinical trials are conducted in patient populations for which the medicine is eventually intended. Phase Ilia clinical trials generate additional data... 

In the centralized procedure, one license to market the drug in all of the EU is issued, and in principle there is only one evaluation of the dossier. In fact, both a rapporteur and corapporteur are appointed and eaeh assesses the dossier with its own... 

The drug substance and finished product specification of any product allow for the presence of low levels of impurities, depending on daily dose and duration of treatment. The permitted levels are specified. It is important that the safety of these allowable impurities is confirmed. The preclinical dossier requires... 

The new GCP requires that sponsors shall compile plan and operating procedures on auditing and implement auditing in conformity with the plan and the procedures, thus auditors audit not only the sponsor s in-house process but also processes at study sites. Within the sponsoring company, usually aU CRFs and study reports are subject to the audit. Study sites are selected for audit based on auditors SOP, usually based on sampling methodology. Audit certificate for each clinical trial is required to be incorporated into new drug submission dossier. 

DMFs are generic dossiers filed with the FDA in order to allow the API to appear in marketed drugs. Thus an API manufacturer files just one application for a product, which can then be used to support approval of any generic based on that API. 

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