GMP News - Pharmaceutical Development / Clinical Trials / GCP

The European Commission (EC) published an updated Version 6.6 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). Amongst others, a new question on radiopharmaceuticals has been added.

The European Commission has published a new Version 3 of the Quick Guide for Sponsors. The revised guide provides clarifications on the submission of the IMPD-Q (Investigational Medicinal Product Dossier - Quality) for the IMP manufacture.

The European Medicines Agency (EMA) held a workshop in June on the quality of Real World Data (RWD) and its use to demonstrate Real World Evidence (RWE). In the meantime, Youtube video recordings of both days have been published.

Publications in the'USP Proposals PF 49_5 also include a draft chapter <1060> "Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins".

The FDA published a draft guidance that discusses quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.

The FDA published a draft guidance for institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions (IPEAS).

An expert group of the US Pharmacopoeia (USP) is working on a new chapter on wetting properties of pharmaceutical systems, which may have relevance for both batch and continuous manufacturing. The draft can be found in Pharmaceutical Forum PF49(5).