EMA Invites Comments on New Guidance for Vaccine Development - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Invites Comments on New Guidance for Vaccine Development


The European Medicines Agency (EMA) has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

The new modular guideline is intended to cover and update in one single, consolidated document the existing guidance on regulatory, quality, non-clinical and clinical aspects of the development of all types of influenza vaccines, in all epidemiological situations, i.e., seasonal, pandemic and pre-pandemic.

It has been developed based on the experience gained from many years of seasonal vaccination campaigns, the 2009/2010 influenza A (H1N1) pandemic, requests for scientific advice received from vaccine developers and applications for marketing authorization.

The guidance provided applies to vaccines for which ample regulatory experience has been gained, as well as to some novel types of vaccines based on established surface antigens.
The most notable changes introduced by the non-clinical and clinical module of the guideline include: new terminology for pandemic vaccines to replace the term pandemic mock up vaccine with ‘pandemic preparedness vaccines’ and the term pre-pandemic vaccines with ‘zoonotic influenza vaccines’; revision of criteria for the assessment of immunogenicity in favor of a broader evaluation of immune responses rather than the use of seroprotection rate and hemagglutination inhibition as the main tests for evaluation; and an introduction of effectiveness studies for seasonal influenza vaccines as requirements in the post-authorization phase.

The guidance on enhanced safety surveillance for seasonal influenza vaccines, which was adopted as a stand-alone document in April 2014, will be annexed to this module following its finalization.

Comments are invited until 31 January 2015 and should be sent to vwp@ema.europa.eu using the form provided. 

Source: EMA

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications

Click here