Pharmaceutical quality of inhalation and nasal products - Scientific guideline

This guideline replaces the guideline on pharmaceutical quality of inhalation and nasal products  (EMEA/CHMP/QWP/49313/2005 Corr) and Quality of medicines questions and answers: Part 2 Specific type of products – Dry product inhalers; Orally inhaled products; Storage – What are the requirements for storage orientation recommendations in the product information for pressurised metered dose inhalers.

This document outlined expected quality aspects of human medicinal products intended for delivery of the active substance into the lungs, or to the nasal mucosa, with the purpose of evoking a local or systemic effect. These include pressurised metered dose inhalers, dry powder inhalers, products for nebulisation, and nonpressurised, metered dose inhalers, as well as pressurised metered dose nasal sprays, nasal powders, and nasal liquids.

Keywords: Inhalation medicinal products, nasal medicinal products, pharmaceutical quality, pressurised metered-dose inhalers (pMDI), dry powder inhalers (DPI), medicinal products for nebulisation, non-pressurised metered-dose inhalers, nasal sprays, nasal powders, nasal liquids

Current effective version - currently under consultation

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Consultation dates: 12/04/2024 to 31/10/2024Draft: consultation openReference Number: EMA/CHMP/20607/2024Summary:

This guideline replaces the guideline on pharmaceutical quality of inhalation and nasal products  (EMEA/CHMP/QWP/49313/2005 Corr) and Quality of medicines questions and answers: Part 2 Specific  type of products – Dry product inhalers; Orally inhaled products; Storage – What are the requirements for storage orientation recommendations in the product information for pressurised metered dose inhalers.

Guideline on the pharmaceutical quality of inhalation and nasal products

AdoptedLegal effective date: 01/10/2006Reference Number: EMEA/CHMP/QWP/49313/2005

Document history

Guideline on the pharmaceutical quality of inhalation and nasal products

AdoptedLegal effective date: 01/10/2006Reference Number: EMEA/CHMP/QWP/49313/2005

Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products

Consultation dates: 22/03/2017 to 22/06/2017Draft: consultation closedReference Number: EMA/CHMP/QWP/115777/2017Summary:

This concept paper concerns the guidance document on quality aspects of human medicinal products intended for delivery of drug substance into the lungs or to the nasal mucosa with the purpose of evoking local or systemic effect. These include pressurised metered dose inhalers, dry powder inhalers, products for nebulisation and non-pressurised metered dose inhalers as well as pressurised metered dose nasal sprays, nasal powders and nasal liquids.