EMA: Pilots for Post-Authorisation Changes
In collaboration with the World Health Organization (WHO), the European Medicines Agency (EMA) supports a pilot programme that allows pharmaceutical companies to submit EMA-approved post-authorisation changes (i.e. variations) to multiple non-EU national authorities.
Currently, 10 ongoing pilot projects involve up to 100 national authorities. These pilots primarily address major manufacturing changes, aimimg to minimize potential disruptions in the supply of medicines and vaccines.
Source:
EMA: Reliance for post-authorisation changes: pilots for the pharmaceutical industry
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
