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Apr 16, 2020

Pharmacovigilance Inspection Metrics Report (April 2018 – March 2019)
On 15 April 2020 the UK MHRA published the annual report of pharmacovigilance inspection metrics from April 2018 till March 2019.

During the period 01 April 2018 to 31 March 2019, the MHRA’s Good Pharmacovigilance Practice (GPvP) inspectorate conducted 18 inspections of marketing authorisation holders (MAHs). The purpose of these inspections was to examine compliance with existing EU and national pharmacovigilance regulations and guidelines. This report contains data relating to all 18 inspections conducted during the period.

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Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
On 13 April 2020 the FDA announced the availability of this final guidance for industry.

This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices to support the indicated uses of multiple drug or biological oncology products, when appropriate. This guidance builds upon existing policy regarding the labeling of companion diagnostics. In a prior guidance issued in 2014, the Agency stated that if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group of therapeutic products, the companion diagnostic’s intended use/indications for use should name the specific group of therapeutic products, rather than specific products. This guidance expands on the policy statement in the 2014 guidance by recommending that companion diagnostic developers consider a number of factors, including but not limited to those discussed in this guidance, when determining whether their test could be developed, or the labeling for approved companion diagnostics could be revised through a supplement, to support a broader labeling claim such as use with a specific group of oncology therapeutic products (rather than listing an individual therapeutic product(s)).

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Guidance on regulatory requirements in the context of the COVID-19 pandemic
On 10 April the European Commission, EMA and the European medicines regulatory network have developed a Q&A document to provide guidance to stakeholders on regulatory expectations for medicinal products for human use during the COVID-19 pandemic.

The current pandemic is a global public health emergency causing major disruptions that impact citizens, patients and businesses, including the activities of pharmaceutical companies. The document explains some regulatory flexibilities that can be applied to help pharmaceutical companies cope with the consequences of the pandemic, while ensuring a high level of quality, safety and efficacy for medicinal products made available to patients in the EU.

The Q&A document outlines areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders may be faced with in the context of COVID-19. The measures introduced cover different areas of the regulation of medicines such as marketing authorisations and regulatory procedures, manufacturing and importation of active pharmaceutical ingredients (APIs) and finished products, quality variations, and labelling and packaging requirements with flexibility to facilitate the movement of medicinal products within the EU. Some of the measures described are reserved for crucial medicines for use in COVID-19 patients.

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Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
On 9 April 2020 the UK MHRA published the guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home.

Due to the COVID-19 pandemic, remote working has increased. Some organisations have advised that their processes for approving paper documents with wet ink signatures are no longer achievable.

This guidance is to enable organisations to consider alternative methods whilst maintaining basic control of documents.

The guidance is for organisations involved in the pharmaceutical lifecycle (GMP, GDP, GLP, GCP & GPvP) or GLP studies regulated by the MHRA.

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Bioresearch Monitoring (BIMO) Fiscal Year 2019 Metrics
On 8 April 2020 the FDA published the bioresearch monitoring inspection metrics for the fiscal year 2019.

The inspectional data cover all aspects of FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, bioequivalence, and good laboratory practices) for all Centers, as applicable. These data were provided by the individual Centers and may differ from other inspection data available on FDA’s website, as different criteria and/or methods for compiling the information may have been used.

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Overview of Comments Received on ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 7 April 2020 the EMA published an overview of comments received from 40 stakeholders on ICH guideline E8(R1).

The ICH guideline 'General considerations for clinical studies' is intended to describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities, provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification during study planning of factors that are critical to the quality of the study, and the management of risks to those factors during study conduct. It provides an overview of the types of clinical studies performed during the product lifecycle, and describe the aspects of those studies that support the determination of which quality factors are critical to ensuring the protection of study subjects, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives.

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Notice to Sponsors on Validation and Qualification of Computerised Systems Used in Clinical Trials
On 7 April 2020 the EMA provided guidance in forms of questions and answers (Q&As) on GCP.

EMA has published a notice for clinical trial sponsors to highlight the requirements for the qualification and validation of computerised systems used for managing clinical trial data. This is based on inspection findings and taking into account implications on the integrity, reliability, robustness and acceptability of data in marketing authorisation applications.

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Global Coronavirus COVID-19 Clinical Trial Tracker
Cytel announced the launch of an open-access global COVID-19 Clinical Trial Tracker.

Cytel is proud to announce the launch of an open-access global COVID-19 Clinical Trial Tracker. Funded in part by The Bill and Melinda Gates Foundation, the tracker will help facilitate greater collaboration for critical stakeholders who need to understand the global response to finding a solution to the COVID-19 outbreak.

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ICH M1 Points to Consider Working Group and MedDRA MSSO Communication on Coronavirus
On 1 April 2020 the ICH announced the notification on MedDRA terms for coronavirus concepts now available

The coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue. The ICH M1 Points to Consider Working Group and the MedDRA MSSO, with the approval of the MedDRA Management Committee, is issuing a Notification for MedDRA users regarding existing and new terms for coronavirus concepts.

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