Abstract

STUDY OF QUALITY REQUIREMENTS OF METER DOSE INHALER REGULATION IN US AND EUROPE

Deval Shah*, Mr. Darshil Shah* and Dr. Dilip Maheshwari

ABSTRACT

Aerosol drug delivery systems are gaining much more importance in present and have a great advantage over other route of administration. Meter dose inhaler was introduced to deliver asthma medication in a convenient and reliable multi dose preparation. The key components of the MDIs device play important role in determining drug delivery to the lungs, hence the regulation of the MDIs device is necessary. Centre for drug evaluation and research (CDER) under FDA and Committee for proprietary medicinal products (CPMP) under EMA is responsible for regulation of MDI in US and Europe respectively. The registration of MDIs 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 MDIs 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 MDIs which comply with regulatory requirements of both countries.

Keywords: Meter dose inhaler, FDA, EMA, Common technical Document, Quality Requirements.