GMP News - Pharmaceutical Development / Clinical Trials / GCP

The International Narcotics Control Board (INCB) recently published its report for 2018 with a strong focus on cannabis. Read more about Cannabis and cannabinoids for medical, scientific and “recreational” use: risks and benefits.

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018. 

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

The European Commission has published version 13 of  the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use.

A new post, "Is it really a First in Human trial? Categorizing and assessing the risks correctly" has just been published on the MHRA Inspectorate blog.

The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and the related Q&A documents have given the topic cross contamination a greater importance.