Pharma GMP News of the Week: 5-June-2022

Period: May 29, 2022 to June 4, 2022

Official Medicines Control Laboratories (OMCLs) participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines

Date of paper: May 31, 2022

In the year 2020, Recalls of many batches of metformin containing medicines have been done because of the detection of N-nitrosodimethylamine (NDMA) in amounts above the acceptable intake (AI) of 96 ng per day.

Before initiating the recall, OMCL participated in an international collaboration of regulatory laboratories to test the API and Finished Products for this impurity detection.

Detailed article on this topic “International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin‑Containing Medicines” at springer.com is available to read on the link below.

Source: https://link.springer.com/epdf/10.1208/s12248-022-00702-4?sharing_token=R7GjnmHA3NNw-prAoc0lHpil69fZbNCDjUAQWCaB_Pu2RctIEDu0hg1U75p_i2a0fUm4Z961N1hBvaQDfx_wOr5V3clHUeiq4bw0WyE3-dp1TEIyZIUPG8459F2PAIYoipFVdG_xYdl91bOynYtq1Py4RmuZCW9aaXkKVVieOYA%3D 

Springer published “Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency”

Published online on: May 24, 2022

Regulatory agencies do facility inspections to ensure Good clinical practice (GCP) are followed and to ensure the data integrity to safe-guard the rights, safety, and health conditions of study candidates. The inspections are being carried out to ensure that the clinical trials are done in compliance with GCP and inline with the applicable regulations.

The whitepaper published a study that compared outcomes on 49 GCP inspections carried out by the two agencies and summarizes the differences and similarities in findings for similar inspection deficiencies.

Source: https://link.springer.com/content/pdf/10.1007/s43441-022-00417-w.pdf

The ICH conducted a hybrid meeting on May 21 to 25, 2022, in Athens, Greece, for the first time. 

Date of paper: June 1, 2022

The hybrid meeting was done where both in-person and virtual participation were present from 7 Groups, the MedDRA Management Committee, the ICH Management Committee, and the ICH Assembly.

Topic discussed and details of the meeting are:

  • Further expansion of ICH Membership and Observership
  • Progress on existing ICH Guidelines and harmonisation activities
  • New areas of ICH harmonisation
  • Training
  • MedDRA
  • Communication

For detailed reading refer link below.

Source: https://admin.ich.org/sites/default/files/inline-files/ICH44_HybridMeeting_PressRelease_2022_0601_FINAL.pdf 

The European Medicines Agency published a “Complex clinical trials – Questions and answers”

Published online on: June 2, 2022

The objective of this document is to support sponsors, applicants and clinical trialists to advise regarding scientific aspects and the planning, set-up, conduct, submission for obtaining CT authorisation (CTA), reporting and transparency, analysis and interpretation of complex clinical trials under the EU Clinical Trials Regulation as well as their use in submissions for MA.

Source: https://ec.europa.eu/health/system/files/2022-06/medicinal_qa_complex_clinical-trials_en.pdf 

The European Commission published a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards

Date of notification: June 1, 2022

The European Commission published a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards for comments. 

The standards are related to the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

Source: https://ec.europa.eu/docsroom/documents/50274/attachments/1/translations/en/renditions/native

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