Aerosol drug delivery systems are gaining much more importance in present and have a great advantage over other route of administration. Dry Powder Inhaler was introduced to deliver asthma medication in an exceedingly convenient and reliable multi dose preparation. The key elements of the DPIs device play important role in determining drug delivery to the lungs, hence the regulation of the DPIs device is Important. Centre for drug evaluation and research (CDER) under FDA and Committee for proprietary medicinal products (CPMP) under EMA is responsible for regulation of DPI in US and Europe respectively. The Registration of DPIs in US as well as Europe is done through Common Technical Document (CTD) format. This article gives information of regulatory requirements of quality section of DPIs in US and Europe. The regulatory requirements of quality section are varying from each other so it is challenging for globalized pharmaceutical companies to develop DPIs which comply with regulatory requirements of both countries.
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