Quality Requirements and Regulatory Strategy for Aerosol and Nasal Spray in US, Europe in Comparison with ASEAN, South Africa and Brazil

Abstract

The Formulation and Drug delivery device together makes Aerosol and Nasal spray more complex unit. These products are famous now a day due to their drug delivery system. Countries which are taken into consideration are US, Europe, Brazil, ASEAN and South Africa. The quality part is a big challenge while submission of dossier for Aerosol and Nasal spray in taken countries. For Aerosol quality tests are important to conduct at the stage of development and during the manufacturing as well. It is difficult to maintain quality throughout its shelf life because of complexity. The US and Europe have established guidelines for the quality and clinical requirements. The guidelines clarify the manufacturer about the quality parameters criteria and specification tests to prove bio equivalence of the generic product. In Brazil, ANVISA increases the time period of approval of generic Aerosol products from three to four year because the quality is major concern due to the complexity and the formulation and device both are important to be reviewed as they have a directly linked with drug deposition in the lungs. A guideline proposed by ANVISA demonstrates require aspects for filing of generic Aerosol product. The regulatory strategy for submission is implemented in areas like, non-clinical/ clinical data submission, dossier preparation etc. The approaches to show bio equivalence in US and Europe is established. Furthermore, regulatory strategy framework explained through case study which helpful in submission of BA/BE submission. First case, the product is not globally approved and second, the product is already approved in regulated market. Such region like ASEAN, South Africa requires well-resourced regulatory structures to regulate this type of product in to their market.