GMP NEWS 2019

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.

Blockchain should be able to help solve the challenges of the increasingly complex sales system. But what is Blockchain anyway?

The International Council for Harmonization (ICH) recently published a new reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs".

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 FDA launched the development of an enhanced electronic, interoperable U.S. track-and-trace system for industry set to go into effect in 2023.

What happens if a certificate is issued before the withdrawal date but released after this date? New Q&As give a clear answer.

The European  Medicines Agency (EMA) has started with the relocation to the Netherlands and informs about contact details and continuation of the main activities.

The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.