Lifecycle Management of Respiratory Products in Australia, New Zealand and Mena Countries

Abstract

Respiratory diseases impose an immense worldwide health burden. Asthma, acute lower respiratory tract diseases, tuberculosis (TB) and lung cancer are serious causes of extreme disease and death worldwide. Development of respiratory products, or as they are often termed as orally inhaled and nasal drug products, relates to targeting drug delivery to either the pulmonary route or to the nasal cavity with the overall outcome for either local or systemic delivery. Respiratory products are a complex dosage form combining formulation and drug delivery device together. Orally inhaled fixed-dose combination drugs (FDCs) have evolved during the past decade as an effective treatment form for managing asthma and chronic obstructive pulmonary disease. The development of such respiratory products encompass a complex interaction of three components – complex devices, complex non-standard process and analytical technologies and an even more complicated understanding of the product with respect to its unique critical quality attributes – the interplay of these three factors need to be carefully understood and balanced across development and commercialization to ensure a quality product output. A number of respiratory products like nasal sprays, aerosol, metered dose inhalers and dry powder inhalers are available in the market to cure the respiratory diseases. Lifecycle management is important in order to maintain the quality of product throughout the shelf life of the product. The present study focuses on respiratory product variations in Australia, New Zealand and Middle East North African (MENA) countries including procedure and timeline and variation policies. These countries have well established guidelines in order to ensure quality, efficacy and safety of the products in the market. Any kind of change or alteration made in the process or product is supposed to be registered with the regulatory authority in that country which then has to go through the variation guidelines and all the required documentation are provided according to the prescribed format. Further regulatory requirement for variation and various case studies associated to variations for different types and formulations of respiratory products have been included.