Safety Observer 201

ICH E6(R3): GCP

The ICH E6(R3) draft Guideline on Good Clinical Practice (GCP) has entered the public consultation period and various authorities including the FDA, the EMA and the MHRA are inviting stakeholders to submit comments.

CIOMS XIII: RWD & RWE

CIOMS has launched a public consultation on the draft report of Working Group XIII, which covers Real-World Data (RWD) and Real-World Evidence (RWE) in Regulatory Decision Making.

FDA & AI

The FDA is calling for comments on a new discussion paper entitled: “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products”.

FDA: New PMI rule

The FDA has published a Proposed Rule, which would require a new Patient Medication Information (PMI) in replacement of Medication Guides or Patient Package Inserts.

Ethiopia: PV Guideline

The EFDA (Ethiopian Food and Drug Authority) has published the fourth edition of its Pharmacovigilance Guideline, which brings new requirements for MAHs including Local QPPV and PSMF.