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Qualifying Container-Closure Systems for OINDPs: Current and Future Regulatory Expectations

Suman JD, Williams G, Pacaud H.

RDD Asia 2014. Volume , 2014: 99-108.

Abstract:

The route toward regulatory approval of nasal drug products is different depending on the target market. One of the first challenges is sourcing device components that meet both quality and price expectations. The issue has become increasingly important as quality requirements from the supply chain are rising, even in developing markets. For example, the Chinese Food and Drug Adminstration (CFDA) is beginning to focus on extractable and leachable levels. As regulators look to the United States (US) or the European Union (EU) for their approaches, we expect that the bar will be raised for both generic and new drug products in Asia. For those that are also seeking to market in the US, Canada, Europe, or Brazil (BR), the regulatory pathway is more defined. FDA has now released draft drug product specific guidance documents [1-4] that outline both in vivo and in vitro programs for generic orally inhaled and nasal drug products (OINDP). Nonetheless, there are still challenges that exist regarding proof of equivalence, particularly with in vitro tests such as spray pattern and droplet size for nasal sprays. The objective of this paper is to differentiate the requirements for Asian and more regulated markets, as well as to highlight global pathways to increase the probability for success for in vitro bioequivalence. In addition, other regulatory pathways such as “super generics” in the US or Similars in Brazil are discussed.