Whitepaper

Regulatory Landscape for Transition to Low Global Warming Potential (LGWP) Propellants for Pressurised Metered Dose Inhalers (pMDIs)

Published 06th December 2024

Regulatory landscape for transition to low global warming potential (LGWP) propellants for pressurised metered dose inhalers (pMDIs) cover

As the global focus on climate change intensifies, the pharmaceutical industry must transition to more sustainable practices. This whitepaper summarises the regulatory requirements for transitioning to low global warming potential (LGWP) propellants in pressurised metered dose inhalers (pMDIs).

The paper focuses on European regulations and covers the background of the transition, including a brief look at the history of the previous transition from CFC propellants and the rationale for the current move. The regulatory requirements for quality, nonclinical, and clinical data are covered in detail, followed by an update on development status of two new propellants that will be key to the successful implementation in the next generation of pMDIs.

While DLRC provides regulatory expertise, the whitepaper is written in partnership with Orbia Fluor & Energy Materials (branded as Koura), whose products contribute to the treatment of respiratory conditions through their innovative LGWP pMDIs.

 

Meet the Experts

Ian Ashurst Principal Regulatory Consultant, DLRC

Ian Ashurst
Principal Regulatory Consultant, DLRC

Ian is a Principal Regulatory Consultant at DLRC. He is a Fellow of the Royal Pharmaceutical Society with a PhD in Pharmaceutics. He is now in his 40th year working in the pharmaceutical industry and has worked in pharmaceutical development for 17 years, CMC technical leadership for 14 years, worked as a quality assessor at the MHRA for three years and is now in his 6th year at DLRC. He has developed and assessed many inhaled products such as Serevent, Flovent, Ventolin, Seretide and Relvar, to name a few. His experience sitting on three sides of the table as a medicine developer, regulator and consultant to medicine developers, gives him a unique perspective and an ability to help clients understand how regulators think and develop strategies likely to succeed. Ian has an excellent record in navigating complex technical and regulatory issues. This record has been honed by many years of working on the propellant transition from CFC to HFA propellants in the 1990s and early 2000s and more recently helping DLRC's clients respond to challenging questions from regulators.

Sharon Robinson Associate Director & Senior Regulatory Consultant, DLRC

Sharon Robinson
Associate Director & Senior Regulatory Consultant, DLRC

Sharon is a Senior Regulatory Consultant at DLRC with over 20 years of experience and specific expertise in nonclinical regulatory topics. Nonclinical strategy plays a crucial role in the drug development process, and a well-planned nonclinical regulatory strategy can help save time and money. Focusing on nonclinical regulatory topics, Sharon supports clients at all stages of the product life cycle (from early phase development, Scientific Advice, PIPs, and INDs to MAA/NDA/BLA and post-approval procedures) across different research and therapy areas and has experience with both small molecules and biologics. Sharon has held positions in contract research organisations, large pharmaceutical companies, and small biotechs and led the nonclinical regulatory activities for multiple small molecule and biologics filings in the EU and US.

James Murray Programme Manager, Orbia Fluor & Energy Materials (Koura)

James Murray
Programme Manager, Orbia Fluor & Energy Materials (Koura)

James Murray is a Programme Manager at Orbia Fluor & Energy Materials (Koura) with >10 years’ experience. James started life in the R&D labs as a process chemist before moving in to regulated medical propellants. He has a well-rounded knowledge base within the industry, having held roles in quality, validation and development of medical propellants. James now manages the Zephex® 152a nonclinical development programme, contract development & manufacturing capabilities and engages proactively with current and potential customers, covering topics such as regulatory status, stability and quality.

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