EMA Update on Quality Guidelines on Inhalation and Nasal Products
Dr. Claudia Vincenzi
Specialised Scientific Disciplines Department
European Medicines Agency
30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom
Tel. +44 (0)20 3660 8864 | Fax +44 (0)20 3660 5515
[email protected] | www.ema.europa.eu
For an orally inhaled product, there are two guidelines where quality aspects are discussed; the “Guideline on Pharmaceutical Quality of Inhalation and Nasal Products” EMEA/CHMP/QWP/49313/2005 Corr, which outlines expected quality aspects of drug products to be marketed and the multidisciplinary “Guideline On The Requirements For Clinical Documentation for Orally Inhaled Products…” CPMP/EWP/4151/00 Rev. 1, a guideline focussing on the establishment of therapeutic equivalence of two orally inhaled products. These guidelines have been written to complement each other.
The current guideline on quality of inhalation and nasal products came into effect in 2006 and since then a lot of experience has been gained mainly with regard to establishment of therapeutic equivalence but also new combinations and new chemical entities. During review of applications and scientific advices several issues are frequently being discussed and some Question & Answers have been adopted. Similarly, the experience gained over the years’ in demonstrating therapeutic equivalence of two orally inhaled products points at a need to clarify certain aspects related to the establishment of therapeutic equivalence based on pharmaceutical data. Additionally, there have also been advances in inhaler technology of pressurised metered dose inhalers (MDI) and dry powder inhalers (DPI) resulting in better drug delivery characteristics.
As the changes to the guideline on therapeutic equivalence will have impact on the quality guideline, both guidelines are under parallel revision, which gives the opportunity to align the requirements for orally inhaled product.
Several items have been identified for discussion, such as dose proportionality, flow-rate dependency, stage grouping, requirements on data for an inhalation spray together with a spacer/holding chamber, the possibility of using new abbreviated methods, to conduct intra- and inter-device variability for delivered dose uniformity in one test, guidance on how to justify that the manufacturing process may be considered as a standard process, evaluating essential requirements for CE marked and non-CE marked devices, and updating of relevant parts to reflect the concepts of ICH Q8/Q9/Q10 and life cycle management.
The consultation ended in June 2017 and more than 100 comments were received on quality aspects from industry, regulatory agencies, consortia and other groups.
In her presentation, titled “EMA Update on the Quality Guideline on Inhalation and Nasal Products”, Dr. Claudia Vincenzi will provide an update on the revision of the Guideline on the Pharmaceutical Quality of Inhalation and Nasal Product, covering the work that is on-going at EMA, the main items under revision, the comments received from the stakeholders and points for future consideration.