Swissmedic is committed to ensuring the safety, efficacy and quality of medicinal products in Switzerland. As part of its continuous efforts to adapt regulatory requirements to current scientific knowledge and harmonise them internationally, the Position on requirements for the authorisation of orally inhaled products (OIP) with known active substances for the treatment of asthma and/or chronic obstructive pulmonary disease (COPD) has been revised.
Until now, Swissmedic has required clinical studies to demonstrate equivalence between OIP with known active substances and reference products, particularly in the case of inhaled corticosteroids (ICS) (see Swissmedic Journal 06/2014 and 06/2017).
Swissmedic has continually monitored the latest scientific findings and the requirements of other medicinal product authorisation agencies. Experience with the use of OIP with known active substances in countries that authorise such products on the basis of their pharmacokinetic (PK) data has not raised any relevant efficacy or safety concerns. The requirements for authorisation of inhaled and topical preparations containing known active substances in the indications asthma and/or chronic COPD have been revised on this basis.
As a result of this revision, Swissmedic will now also accept PK data as the primary basis for demonstrating equivalence between OIP with known active substances and their reference products.
A stepwise procedure for demonstrating equivalence between OIP with known active substances and their reference products is retained:
- In vitro equivalence – demonstration of equivalence between an inhaled product with known active substances and a reference product solely on the basis of vitro data (in accordance with EMA OIP Guideline CPMP/EWP/4151/00 Rev. 2).
- Equivalence studies with PK or clinical endpoints – if in vitro equivalence cannot be demonstrated, equivalence can be demonstrated using pharmacokinetic studies with/without activated charcoal administration by means of equivalent systemic exposure (as a surrogate parameter for safety) and equivalent pulmonary absorption/deposition (as a surrogate parameter for efficacy). Alternatively, equivalence can be demonstrated in comparative studies using suitable clinical endpoints.
This updated Position takes immediate effect and applies to all new applications for authorisation of OIP with known active substances for the treatment of asthma and/or COPD.