Advisor 469

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

STOP PRESS – global news continued

FDA committed to regulatory oversight of coronavirus vaccines Stephen Hahn and Peter Marks have jointly authored a short ‘FDA Voices’ article (dated 11 September 2020) describing the agency’s scientific and regulatory oversight of vaccines in the context of the coronavirus pandemic. The article notes that the FDA is “committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making”. The FDA’s expectations for the development of COVID-19 vaccines – including clinical trial design, and safety and efficacy considerations – are provided in the guidance document ‘Development and Licensure of Vaccines to Prevent COVID-19’. The guidance also outlines when the agency might consider an emergency use authorisation for a COVID-19 vaccine. The short article repeatedly states the agency’s commitment to being guided by science and data, perhaps acknowledging the pressure it is under to expedite the authorisation of COVID-19 vaccines. Source: On 10 September 2020, the FDA issued new final guidance to help drug and biological product manufacturers prioritise current Good Manufacturing Practice (CGMP) activities, as they transition from operations impacted by the pandemic back to normal manufacturing. The guidance describes how to evaluate and prioritise the remediation of CGMP activities that were delayed, reduced or otherwise modified during the public health emergency, in order to maintain production and drug supply. The policy will remain in effect only for the duration of the COVID-19 pandemic. Source: EMA reports on virtual ICH E6(R3) GCP workshop The European Medicines Agency (EMA) has published a report on its workshop on the International Council for Harmonisation (ICH) E6 GCP Guideline. FDA plans resumption of normal drug and biological product manufacturing

The virtual half-day workshop on 3 June 2020 aimed to gather the views of European patients, healthcare professionals and clinical researchers on clinical trials and applying GCP. The key issues discussed at the meeting and described in the meeting report (published on 28 August 2020) are outlined below. The ICH has initiated the revision of the current E6 GCP Guideline to ensure that in the future it can address the increasing diversity of clinical trial designs and data sources, and the different contexts in which clinical trials can be conducted. E6(R3) will also highlight how GCP principles can be satisfied in a variety of ways. The ICH is committed to engaging stakeholders in the revision process, in particular patient

representatives and academic clinical researchers, to ensure that the final guideline will be appropriate for everyone conducting or participating in clinical trials. The EMA is coordinating the stakeholder engagement process – of which the workshop was part – on behalf of the ICH in Europe. Revision Unlike for E6(R2), the E6(R3) revision will involve a complete rewrite and reorganisation of the current guideline. The aim is to provide • a document describing the overall principles applicable to all clinical trials, ie. that patient safety prevails over scientific and society interest, informed consent is needed, and data should be reliable

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Issue 469, 2020

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