A Comparative Study of Regulations of Nasal Products in the US and EU

  • Sandhya Jaiswal Chandigarh college of pharmacy, chandigarh group of colleges, landran, mohali, Punjab
  • Parshant Sharma
  • Heena Qureshi

Abstract

A study relating to the regulation for nasal products has been conducted for the current review. The analysis emphasized the significance of classifying nasal products. Nasal products are challenging to manufacture in India due to regulatory and logistical issues. In addition to the production guidelines established by the USFDA and EU, the study analyses the prospects for nasal products in the future. Some common policies held by the 2 major international agencies have been shown in this review.


The current evaluation focuses on how nasal product production should be done in conjunction with other product production and will examine the fundamental recommendations made by the USFDA and EU, as well as whether or not there is a specific category of recommendations for nasal products.


Conclusions


The article demonstrates the USFDA and EU guidelines, and it was found that there were not major differences between the guidelines of the two. Instead, there are only minor differences between the infrastructures of the two agencies related to nasal products.

Keywords: Regulations, Nasal Products, nasal sprays, Dry Powder Inhalers (DPIs), USFDA, EU

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How to Cite
Jaiswal, S., P. Sharma, and H. Qureshi. “A Comparative Study of Regulations of Nasal Products in the US and EU”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 1, Mar. 2023, pp. 15-23, doi:10.22270/ijdra.v11i1.573.