Friday, 1 March 2019

Updated Technical Guide for elaborating monographs on vaccines and sera for human use


At its 162nd session, the European Pharmacopoeia (Ph. Eur.) Commission approved a new edition of the Guide for the elaboration and use of monographs on vaccines and immunosera for human use.

The Guide provides guidance to experts on the information to be included in Ph. Eur. monographs related to vaccines and sera for human use, and to harmonise the style of the different monographs.

The new edition of the Guide takes into account the experience gained in recent years in elaborating monographs in this field, and reflects recent developments in the Ph. Eur.
The Guide is primarily designed for Ph. Eur. experts drafting monographs on vaccines and sera, but it also provides useful information to help users better understand the requirements and structure of these monographs.

For details, see: https://www.edqm.eu/sites/default/files/tg_vaccines_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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