Advisor 465

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

STOP PRESS – global news

Free scientific advice to academia developing medicines for rare diseases On 23 June 2020, the European Medicines Agency announced a waiver of fees for scientific advice for academia developing orphan medicines. The academic sector plays an important role in the development of innovative medicines and scientific methods, with the potential to benefit patients with rare diseases. Early interaction with EU regulators is important for academia, to help them navigate the regulatory process and to ensure robust evidence is generated to establish a medicine’s benefits and risks. Ultimately, it helps the academic sector to translate its discoveries into authorised patient-focused medicines. However, the fees for protocol assistance can be prohibitive. Source: Global regulators discuss data requirements for Phase 3 trials of COVID-19 vaccines On 22 June 2020, international regulators from 28 regulatory authorities and the World Health Organization discussed COVID-19 vaccine development and the evidence needed for regulatory decision making, at the second regulatory workshop on COVID-19 vaccines. The rapid authorisation of COVID-19 vaccines requires robust and sound scientific evidence on quality, safety and efficacy. It was agreed that international regulatory convergence, where possible, on certain key aspects of Phase 3 trial design will help developers to generate robust evidence on the quality, safety and efficacy of potential COVID-19 vaccines that meets the needs of regulators around the globe. Topics discussed included eligibility criteria for the inclusion of diverse populations, primary endpoints and other methodological considerations related to Phase 3 trial design. Source:

Global discussion on new priorities to strengthen medicines collaboration Representatives from the European Commission, the European Medicines Agency and the FDA held their 2020 bilateral regulatory dialogue meeting on 18 and 19 June. During the virtual meeting, the authorities reviewed ongoing joint initiatives, discussed strategic priorities for the coming years and identified areas where their current close collaboration can be further strengthened. Topics discussed included • sharing experience and common challenges relating to COVID-19 vaccines • cooperation on bespoke therapies for ultrarare diseases • using real-world evidence to support regulatory decisions • the mutual recognition agreement on Good NIH platform to harness COVID-19 patient data to speed treatments Researchers in many countries are battling to find treatments and vaccines for COVID-19. The US National Institutes of Health (NIH) has launched the National COVID Cohort Collaborative (N3C), a new initiative that aims to build a centralised national data resource – the NCATS N3C Data Enclave – that the research community can use to study COVID-19, and identify potential treatments as the pandemic continues to evolve. N3C will enable the rapid collection and analysis of clinical, laboratory and diagnostic data from organisations nationwide. It will harmonise the aggregated information into a standard format and then make it rapidly available to researchers and healthcare providers to help accelerate COVID-19 research and provide information that may improve clinical care. Source: Manufacturing Practice inspections • orphan and paediatric medicines. Source:

CBER updates list of guidance documents expected in 2020 The FDA’s Center for Biologics Evaluation and Research (CBER) – the division that regulates biological products for human use – has updated the annual list of guidance documents that it expects to deliver in 2020. The list indicates which guidance documents have already been delivered; although not stated explicitly, the various documents related to COVID-19 may be the reason for the update. Source:

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