EMA offers Gateway user organisations the possibility to test the receipt of the 3rd acknowledgment in the External Compliance Testing environment as of 1 July 2015
ASPHALION has been working for 10 years in biotech projects and has become one of the leading regulatory services companies for Biologicals and Advanced Therapy Medicinal Products.
The alliance allows to effectively manage submission content, mitigate compliance risk and bring products to market faster.
As from 16 February 2015, the use of the web application for electronic entry of the Summary of Product Characteristics and Patient Information Leaflet is mandatory.
On 29 October 2014, EMA presented the final version of their guideline on biosimilars. This document replaces the previous guidance document of 2005, provides several clarifications and introduces one important change intended to ease global development of biosimilars.
European Comission: Notice to applicants, update of variations and renewal application forms (human and veterinary)
The Notice to Applicants, has been updated with an application form for the submission of variations and renewal.