Yesterday (12 April 2024) the European Medicines Agency released new guidance on "The Pharmaceutical Quality of Inhalation & Nasal Medicinal Products" and "Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)".
Inhalation medicinal product: A finished medicinal product (including the delivery device, where applicable) whose intended site of deposition is the respiratory tract. The site of action may be local or systemic.
Nasal medicinal product: A finished medicinal product (including the delivery device, where applicable) whose intended site of deposition is the nasal and/or pharyngeal region. The site of action may be local or systemic.
This guideline concerns the quality aspects of human medicinal products intended to deliver active substance(s) to the lungs or nasal mucosa with the purpose of evoking a local or systemic effect. There is a discussion of inhalation and nasal medicinal product quality issues, as well as the need to test for safety (e.g., excipients and leachables). Other guidance documents, including ICH guidelines, describe additional quality aspects (such as impurities, process validation, stability testing, specifications) as well as safety and effectiveness factors.
The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in new marketing authorisation applications, including abridged applications. The general principles described in this guideline should also be considered when making changes to authorised medicinal products and during development of medicinal products used in clinical trials.
This guideline has been developed for medicinal products containing active substances of synthetic or semi-synthetic origin. However, the general principles described should also be considered for other inhalation and nasal medicinal products with active substances of other origins.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)
This document guides the requirements for demonstrating TE between OIPs, including both, single active substance products and combination products, and focuses on abridged applications. The principles described may also be applied to any other application that involves demonstrating TE against a reference product, such as line extensions, variation submissions, or product development.
In vitro, aspects relevant to the establishment of TE are described in this guideline, but reference is also given to the Guideline on Pharmaceutical Quality of Inhalation and Nasal Products. Both guidelines are written to complement each other and should always be read in conjunction. always be read in conjunction.
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