EMA News: New Revised Guidelines for Demonstrating Therapeutic Equivalence and Pharmaceutical Quality in Inhalation and Nasal Medicinal Products

The EMA has released two guidelines for public consultation, inviting feedback from stakeholders.

1. Guideline on the Requirements for Demonstrating Therapeutic Equivalence Between Orally Inhaled Products (OIP) for Asthma and Chronic Obstructive Pulmonary Disease (COPD)

• Purpose: This guideline, now in its second revision, focuses on the requirements for demonstrating therapeutic equivalence (TE) between orally inhaled products that contain the same active ingredients. It is relevant for treatments used in both adults and children with asthma, as well as in adults with COPD.
• History: Previously known as the “Guideline on the requirements for clinical documentation for orally inhaled products (OIP),” it has been updated to better reflect current practices and advancements.
• Comments Deadline: Stakeholders are invited to submit their comments by 30 October 2024 through the EU survey.

2. Guideline on the Pharmaceutical Quality of Inhalation and Nasal Medicinal Products

• Purpose: This first revision aims to consolidate existing guidance, incorporate recent advancements, common practices, and new regulations, including those related to medical devices. It focuses on the pharmaceutical quality of inhalation and nasal products.
• Relation to Other Guidelines: It is complementary to the first guideline on therapeutic equivalence for OIP, meaning both should be read together for a comprehensive understanding.
• Comments Deadline: Stakeholders are invited to submit their comments by 31 October 2024 through the EU survey.

These guidelines are critical for ensuring the safety, efficacy, and quality of inhalation and nasal medicinal products. Public feedback is essential for refining these guidelines to reflect the latest scientific and regulatory standards.¹

You can access the guidelines here.

Disclaimers

• The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
• Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
• No official support by any organization(s) has been provided or should be inferred

Recommended Reads

• EMA news: Establishing efficacy based on single-arm trials in marketing authorisations
• India’s ascendancy in 2023
• EMA recommends first vaccine to protect older adults from RSV
• Is There a Benefit to the Covid-19 Pandemic?
• COVID-19 Vaccine Development and Testing at a Record-Setting Rate