Other News

New EMA Consultation on the Quality of Inhaled Pharmaceutical Products

It has been a long held understanding within the pharmaceutical industry that the registration of inhaled pharmaceutical products has been somewhat challenging, especially with regard to generic filings.  These issues have mainly centred around the quality section of the dossier and therapeutic equivalence. Recently, the European Medicines Agency (EMA) began a consultation on planned changes to its stance on the pharmaceutical quality of inhaled and nasal products. The EMA has published a concept paper to start bringing its guidance in line with changes in thinking about therapeutic equivalence since it released its current advice in 2006. This is a good move forward for the industry, and shows that the regulators are willing to adapt guidelines in light of industry feedback and experience.

Changes to the EMA’s position on therapeutic equivalence are the top priority for the concept paper on pharmaceutical quality. The EMA has published its concept paper in conjunction with another that deals specifically with how to show the therapeutic equivalence of inhaled treatments of asthma and chronic obstructive pulmonary disease. The second, therapeutic equivalence-focused concept paper is expected to usher in changes that affect the EMA’s position on pharmaceutical quality, forcing the regulator to update the two texts in parallel.

In the quality concept paper, officials at the EMA’s Quality Working Party outline the need to update the guideline to reflect changes to dose proportionality, flow-rate dependency, stage grouping and other topics. The EMA has derived these priorities from its work on the therapeutic equivalence concept paper. That concept paper marks the start of an attempt to adapt a 2009 guideline to reflect the experiences of applicants who have sought to show therapeutic equivalence to an orally inhaled reference product. National competent authorities have received several such filings since the guideline was last updated.  The new guideline will describe a stepwise process to demonstrate equivalence that goes from in vitro studies, to pharmacokinetic tests and on to pharmacodynamic and clinical safety and efficacy trials. Recognising that showing therapeutic equivalence using in vitro and pharmacodynamic data is difficult, the EMA wants the guideline to reflect the relative benefits of pharmacokinetic studies.

The EMA is also using the updates of the two guidelines as an opportunity to address other issues. Topics up for discussion in the therapeutic equivalence text include advances in metered dose inhalers and dry powder inhalers. In addition to therapeutic equivalence, once it starts work on revising the quality guidance the agency plans to look at abbreviated methods for determining aerodynamic particle size distribution, tests of delivered dose uniformity, lifecycle management and other topics.  The quality concept paper is open for comment until the end of June 2017.  The EMA will close the comment period on the therapeutic equivalence text at the end of May.

At ELC Group we continuously stay abreast of all the current developments in regulatory thinking and are able to provide clients with insight and robust intelligence in the development and registration of their current and future product pipeline. Successful registration of inhaled products is just one of our key focus areas within our regulatory affairs division. We look forward to helping companies gain successful registrations on these and many other products.


Please let us know any comments you have on this article:

Also see our

press coverage

News Index

05 Oct 2018

EU/US MRA - Brief overview and update

21 Aug 2018

Brexit - has the music stopped?

13 Jul 2018

Recent EMA Brexit Survey

15 Jun 2018

The EMA: 100 not out

08 May 2018

MHRA sets its post-Brexit strategic direction

12 Apr 2018

Brexit - Stick or Twist?

20 Mar 2018

Clinical Trials: all change 2019

22 Jan 2018

Orphan Medicines: almost 20 years on

15 Dec 2017

Update on Brexit developments

05 Oct 2017

How recent moves by the FDA spell good news for generics in the US

11 Sep 2017

Medicines for the Elderly – is your drug development strategy up to the mark?

14 Aug 2017

The MNAT initiative – what’s new?

19 Jul 2017

ICH Q12: Light at the end of the tunnel…?

05 Jun 2017

Q3D: Are your established products in compliance?

02 Jun 2017

Key pharmacovigilance trends to watch

08 May 2017

EMA updates guidance on PSURs

10 Apr 2017

New EMA Consultation on the Quality of Inhaled Pharmaceutical Products

16 Mar 2017

European Parliament’s adoption of ‘Options for improving access to medicines’ procedure

16 Feb 2017

Article 58: a hidden potential

24 Jan 2017

Global lifesciences partner ELC Group teams with PSR Group for advanced drug development

19 Jan 2017

A positive step forward for Biosimilar registration

20 Dec 2016

Falsified Medicines Directive – Are you making the right preparations?

21 Nov 2016

New Public consultation launched by the European Commission (EC)

19 Oct 2016

Transatlantic collaboration to boost research and development of medicines for rare diseases

03 Jun 2016

ELC Group to showcase regulatory affairs solutions at CPhI events in Shanghai and Barcelona

16 Jun 2015

ELC Group in early-stage development of novel influenza vaccine

09 Jun 2015

ELC Group expands into pharmaceutical product development market

21 Apr 2015

ELC Group signs 1.5 million Euro regulatory affairs contract with Chinese pharma giant

24 Feb 2015

Fast-growing regulatory affairs service provider ELC Group expands corporate presence in Czech Republic

02 Feb 2015

ELC GROUP to present at “Regulatory & Legal Affairs in Russia 2015” Conference

15 Sep 2014

Pharma eReport delivers V5-compliant solution to help MAHs meet December 31st XEVMPD resubmission deadline

20 Aug 2014

ELC Group Appoints Dr. Siddharth Chachad as Head of Global Clinical Development and Medical Affairs

28 Jul 2014

ELC Group Appoints Head of Regulatory Affairs for Russia and CIS

14 Apr 2014

Global regulatory affairs specialist ELC Group appoints Localization Business Development Manager for new US Office

10 Oct 2013

Global regulatory affairs specialist ELC Group accelerates international expansion plans following 25% revenue growth in 2013

17 Sep 2013

Global regulatory affairs specialist ELC Group appoints former MHRA Expert Medical Assessor

23 Apr 2013

Global regulatory affairs specialist ELC Group receives accreditation to provide readability testing in Romania

27 Feb 2013

Global regulatory affairs specialist ELC Group to deliver pharmaceutical training event in Latvia

20 Feb 2013

Global pharmaceutical regulatory affairs specialist ELC Group launches Clinical Trials services

10 Jan 2013

Global pharmaceutical regulatory affairs specialist ELC Group hosts International Training Seminar in Mumbai, India

31 Dec 2012

2012 Events

07 Nov 2012

Global pharmaceutical regulatory affairs specialist ELC Group establishes new office in Singapore

22 Aug 2012

Global pharmaceutical regulatory affairs specialist ELC Group increases operational support in Ahmedabad

12 Jun 2012

XEVMPD software provider Pharma eReport launches Excel Data Import Service

06 Jun 2012

ELC Group partners with mdi Europa GmbH to offer end-to-end regulatory solution for medical device companies in Europe

28 Mar 2012

ELC Group joins DIA EuroMeeting in Copenhagen

21 Mar 2012

EVMPD software provider Pharma eReport announces full general availability of Centrality XEVMPD compliance solution

08 Mar 2012

ELC Group Hosts Successful International Regulatory Seminar

06 Mar 2012

Pharmaceutical regulatory affairs specialist ELC Group opens new office in Mumbai

23 Feb 2012

Regulatory challenges for 2012 and their impact on marketing authorisation

21 Feb 2012

ELC Group launches new software subsidiary Pharma eReport to provide complete EVMPD compliance solution

08 Feb 2012

Pharmaceutical regulatory affairs specialist ELC Group establishes global HQ in Cambridge, UK

07 Dec 2011

Past president of TOPRA and ELC GROUP Advisor speaks at International Regulatory Seminar in Ahmedabad 23 February 2012

27 Sep 2011

ELC GROUP Advisory Board’s Dr. Paolo Biffignandi to write opinion column for industry leading publication

12 Jul 2011

ELC Group aim to foster strategic and economic ties within India and China

25 May 2011

ELC Group announces doubled revenues

11 May 2011

ELC Group appoints former TOPRA President