Regulatory Consideration for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

Authored by: Urvashi K Parmar , Jayvadan Patel

Handbook of Lung Targeted Drug Delivery Systems

Print publication date:  October  2021
Online publication date:  October  2021

Print ISBN: 9780367490676
eBook ISBN: 9781003046547
Adobe ISBN:


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Generic drugs aim to provide safe and efficient drugs at a lower cost to the patients. They are comparable to innovator’s drug products and are similar to them in various aspects such as dosage form, strength, route of administration, quality, performance characteristics, and the intention of use. Generic drug products need to be bioequivalent to the innovator’s drug product in order to be proven therapeutically efficient. Specific documentation and tests required for the acceptance of the generics vary country to country. This is mainly due to divergence in culture, historical data, health care systems, regulatory systems, and legal and economic circumstances. The scientific recommendations and requirements for government approval in the US, EU, Brazil, China, and India are discussed in this chapter.

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