Not all trials are the same in terms of risk. Therefore, the MHRA proposesd a simpler and shorter form in lieu of a full Development Safety Update Report, giving a significant time saving.
The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?
MHRA has published new Guidance for import and air freight activities. One is introducing a new function, the Responsible Person (import) - RPi.
In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.
A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).
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 revised Swiss HMG came into force on 1 January 2019 - with some interesting GMP/GDP-relevant changes.
The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.
The European Commission is fostering its support in preparing EU companies for a no deal scenario ("Hard Brexit").