In April 2009 the draft of the "Guideline on Quality, Non-clinical and Clinical Aspects of Live Recombinant Viral Vectored Vaccines" was agreed on by the Vaccine, Biologics, Safety and Gene Therapy Working Parties. In May 2009 it was adopted by CHMP for release for consultation with a deadline for comments until 30 November 2009.
This Draft should bring out a general guidance and should be used together with other dedicated European and ICH guidelines. Its objective is to provide recommendations on the quality, non-clinical and clinical studies which are necessary to compile in order to gain marketing authorisation. The Guideline specifically addresses products entering the marketing authorisation procedure and should be considered by applicants entering clinical trial phases too.
The Note for Guidance on Quality, Non-clinical and Clinical Aspects of Gene Transfer Medicinal Products" (CPMP/BWP/3088/99) from 2001 does not provide enough direction for those developing such vaccines and for the regulators who will be involved in their assessment. For that reason the new guideline is being developed to provide the scientific principles that should be followed in assuring the quality, safety and efficacy of these vaccines. It will replace specific related guidance in CPMP/BWP/3088/99.
More about this draft you can read here.
The ECA Education Course GMP for Vaccine Manufacturers in Prague, Czech Republic, from 28-30 October 2009 provides you with an insight into the GMP requirements of vaccine manufacturing.
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)