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May 18, 2020

EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
On 15 May 2020 the EMA announced the availability of the guidance on how EMA
fast-tracks development support and approval of medicines and vaccines against COVID-19.

This document provides an overview of EMA’s rapid formal review procedures related to COVID-19 and is mainly intended as a procedural guide for developers. It complements other documents published under the guidance for medicine developers and companies on COVID-19 and the respective guidance provided for regular procedures published on the EMA website for research and development and for marketing authorisation.

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Annual Report of the Good Clinical Practice Inspectors’ Working Group 2018
On 14 May 2020 the EMA published the annual report adopted by the GCP Inspectors’ Working Group (IWG) on 12 March 2020.

This document is the eleventh annual report of the GCP IWG. The GCP IWG focuses on harmonisation and coordination of GCP related activities at EU level. The group supports the coordination of the provision of GCP advice and maintains a dialogue with other groups such as CHMP, CVMP, CMDh, PhV IWG, GMP/GDP IWG and other groups, as needed, in areas of common interest.

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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 14 May 2020 the FDA updated the guidance for Industry, Investigators, and Institutional Review Boards.

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

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EMA SME Office Newsletter – Issue 49
On 7 May 2020 the EMA published the SME Office newsletter for small and medium-sized enterprises (SMEs).

The SME Office was set up within the EMA to address the particular needs of smaller companies. It provides information for SMEs on the EU regulatory environment for medicines. In Issue 49, the news bulletin includes regulatory guidance on COVID-19 treatments under investigation, managing clinical trial data, scientific guidelines for human medicines, pharmacovigilance, updated regulatory guidance, medical devices regulation, advanced therapy medicinal products, GMP and other news.

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Explanatory Note to GVP Module VII
On 4 May 2020 the EMA updated the guideline on GVP module VII – Periodic Safety Update Report (PSUR).

The explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the Periodic Safety Update Single Assessment (PSUSA) process. Ultimately, the explanatory note will serve as the basis for the update of GVP Module VII, which will eventually replace it. It should be noted that, as appropriate, points highlighted in this document may also apply to the assessment of centrally authorised products. This note should be read in conjunction with GVP Module VII; where appropriate, references to ICH E2C (R2) are made; it should be used for the preparation of PSURs subject to single assessment.

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Updated Detailed Guidance on ICSRs in the Context of COVID-19: Validity and Coding of ICSRs
On 4 May 2020 the EMA updated the detailed guidance on ICSRs with additional COVID-19 related terms.

This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders published by the European Commission, the guidance regarding COVID-19 related terms published by the MedDRA MSSO and the implementation on 04 May 2020 of the updated MedDRA 23.0 containing additional COVID-19 related terms.

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Australian TGA Pharmacovigilance Inspection Program Metrics Report: January – December 2019
On 4 May 2020 the Health Department of the Australian Government TGA published the metrics report of pharmacovigilance inspections during 2019.

From 1 January 2019 to 31 December 2019, the Therapeutic Goods Administration (TGA) conducted 10 pharmacovigilance inspections of Australian medicine sponsors, in accordance with the Pharmacovigilance Inspection Program.

10 routine pharmacovigilance inspections were completed in 2019. There were no ‘for-cause’ inspections or re-inspections.

Inspections identified:

  • 1 critical deficiency
  • 41 major deficiencies
  • 36 minor deficiencies

This metrics report provides a high-level overview of inspection deficiencies, including a comparison of deficiencies identified in the first reporting period, to assist sponsors with improving their pharmacovigilance systems and preparing for pharmacovigilance inspections.

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MHRA GCP Inspections Metrics Report: 1st April 2017 – 31st March 2018
On 4 May 2020 the UK MHRA issued the GCP inspection metrics report covering the period 1st April 2017 to 31st March 2018.

During the Metrics Period a total of 88 GCP Inspections were undertaken by the MHRA GCP Inspectorate. The types of inspections and findings are presented below.

A total of 12 commercial sponsors were inspected and all have been reported. All these inspections were systems inspections. Of the 12 inspections, 3 (25.0%) had at least one critical finding for Pharmacovigilance, False and Misleading Information and/or Data Integrity and all (100%) had at least one major and/or critical finding.

A total of 10 Contract Research Organisations were inspected and all inspections have been reported. All 10 were systems inspections. Of the 10 inspections, 0 (0.0%) had critical findings and 8 (80.0%) had at least one major finding.

A total of 12 non-commercial organisations were inspected. Of the 12 inspections, 3 (25.0%) had at least one critical finding for Investigational Medicinal Products, Clinical Trial Authorisation or GCP Compliance and 12 (100.0%) had at least one major and/or critical finding.

A total of 9 inspections were done of Commercial Phase 1 Units/Clinical Research Units, 2 inspections were of the same organisation that had one report. Eight of the inspections were routine inspections for the MHRA voluntary phase 1 accreditation scheme and 1 was a systems inspection. None of the inspections were triggered.

Of the 8 reported inspections, none (0%) had a critical finding and 4 (50.0%) had at least one major finding.

A total of 17 investigator sites in the UK were inspected and all were as an associated site with a sponsor/CRO/non-commercial/CTU inspection. Of the 17 inspections, 1 (5.9%) had a critical finding for Data Integrity and 11 (64.7%) had at least one major finding.

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