In 2002 the European Medicinces Agency (EMEA) Biotechnology Working Party drafted the first guidance on the product information (summaries of product characteristics, labelling and patient leaflets) for human vaccines. It was implemented in 2004 and since this time, it was not only an example to compile product information for human vaccines but also a standard-setting model for product information for a number of other classes of biological medicinal product.
The existing vaccines product information guideline remains valid. However, significant developments in both regulatory affairs and in vaccinology have taken place since its 2004 adoption which the guideline does not specifically address. So the following aspects should be discussed:
Now a consultation period of three months is proposed for this concept paper. In this time comments from external and internal stakeholders should be collected and evaluated for the revision uf the guideline.
More details can be found here.
The ECA Course GMP for Vaccine Manufacturers in Prague, Czech Republic, from 28-30 October 2009 provides insight into the GMP requirements of vaccine manufacturing.
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)