The European GDP Association is quite active in supporting its members. What has been achieved in the past six months?
The US Food and Drug Administration (FDA) is launching a new pilot project for enhanced tracing and verification approaches in the pharmaceutical distribution supply chain.
In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".
The International Council for Harmonization (ICH) recently published a new reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs".
To face a possible Hard Brexit, UK plans to amend EU GDP Guidance.
Blockchain should be able to help solve the challenges of the increasingly complex sales system. But what is Blockchain anyway?
In response to the increasing need for a guidance paper for radiopharmaceuticals in non-clinical settings, the EMA has published a "Draft guideline on the non-clinical requirements for radiopharmaceuticals".
The MRA with the USA was supplemented by two further countries: Poland and Slovenia. However some are still missing.
In January 2019, the World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) published a draft guideline dealing specifically with the GMP requirements for the manufacture of radiopharmaceuticals.
The safety feature provisions enetered into force - How to report a falsified pack?