GMP News Drug Safety/Pharmacovigilance

The MHRA GVP inspectorate recently published the latest inspection metrics for the period from April 2020 to March 2021. All inspections in this period were conducted remotely. The largest number of findings in the reporting period related to quality management systems, followed by risk management, and ongoing safety evaluation.

The go-live date for the CTIS is 31 January 2022. In order to help sponsors prepare for using the CTIS, the EMA has now published a new version of the sponsor handbook.

The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.

Canada will lead an ISO international IWG to develop three technical guidelines for Cannabis including one on Good Production Practices (GPP).

The E6(R3) EWG is currently working on ICH´s Guideline on Good Clinical Practice to address the application of GCP principles to the increasingly diverse trial types and data sources. To update international parties on the EWG’s progress ICH hosted a web conference in May. 

The Clinical Trials Regulation (CTR) requires in Article 37 that the sponsor of a clinical trial must submit a lay summary. The European Commission has now published a guideline on "Good Lay Summary Practice" (GLSP).

EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement?