By Neil McAuslane, Stuart Walker (auth.), Cyndy Lumley BSc PhD, Professor Stuart R. Walker BSc PhD(Lond) CChem Cbiol FRSC FIBiol FInstD FRCPath (eds.)

Regulatory assessment is the final significant improvement hurdle that has to be glided by a brand new medication ahead of it reaches the marketplace. At a time while pharmaceutical businesses are reviewing their R&D options, and trying to lessen drug improvement instances, this can be very very important that the evaluation technique is made as effective as attainable. The eleventh CMR Workshop, held in September 1995, supplied the chance for regulatory authority and body of workers from Europe, North the US, Australia and Japan to overtly talk about perspectives and alternate stories just about bettering the evaluate technique. The court cases of this assembly supply a finished review of the present overview procedure worldwide. The members describe the current scenario and spotlight corporation options and regulatory projects to enhance the overview method. This quantity additionally summarises the feedback that have been constructed via the contributors, masking many aspects of this approach, together with the standard and measurement of the file, discussion, submission techniques, suggestions and the reaction to questions.

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Communications There are many opportunities for agency/industry communication during the development process, during review and in the postapproval phase. Effective management of such opportunities is vital in ensuring that communications assist rather than hinder the review process. To develop a close, effective and efficient working relationship, industry should maximise its communications 48 Ensuring Speed of Review: A Transnational Company expertise using a range of media (written, oral, new technologies).

Traditionally, Japanese companies have licensed their new products to US and European pharmaceutical companies. Since development programmes primarily addressed Japanese medical practices and regulatory requirements, the need for additional work for other markets resulted in long development times in other territories. 2. The globalisation and integration of an organisation, with synchronised development of new products between Japan, Europe and the USA should avoid duplication, improve the quality of the dossier, and reduce development time and costs.

There are two elements to consider. The first is the procedures which most regulatory agencies worldwide have for assessing certain applications out of order, such as accelerated review, fast-track procedure and priority assessments. The second issue is facili ties for accelerating the development of certain products for licensing under exceptional circumstances. In the UK the fast-track procedure means that under certain very specialised circumstances the MCA will assess a dossier ahead of tum.

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