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March 23, 2020 Regulatory Affairs

Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part I

Hanneke Dominicus Consultant

Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will try to guide you through all these recommendations and measures with a focus on the European Medicines Agency (EMA), the Agency. In times like this, the Agency has a more important role than ever. Please note that new information is continually evolving therefore always check the applicable websites (EMA, Health Authority in your country, Inspectorate, etc.) if you need more information.

Promotion of Large Randomized Controlled Trials (RCTs) in Multiple Countries in the EU – During the past week, EMA prioritized research aimed at finding therapies for COVID-19. The EMA urged the EU research community to conduct large multi-country randomized controlled studies. These are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments. Small studies or compassionate use programmes planned across Europe are unlikely to generate the required level of evidence to allow clear-cut recommendations. EMA stated that they are ready to support medicine developers with all available regulatory tools to advance and expedite the development of effective measures to fight and prevent the spread of COVID-19. A special EMA team and regulatory tools are available to accelerate approval. Full fee waivers are provided for scientific advice for potential vaccines and treatments for COVID-19. (Source)

Shortages of Medicines – The EU Executive Steering Group first met to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU. This group will identify and coordinate EU-wide actions to protect patients when medicines in the EU are at risk of supply shortage, e.g. due to a temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment. The group will also ensure that patients and healthcare professionals across the EU are kept informed in a consistent and transparent manner. (Source)

Clinical Trials – The impact of COVID-19 on the commencement of new trials, ongoing recruitment and continued subject participation needs to be considered. The ability to confirm eligibility, and to conduct key safety assessments and study evaluations, is of particular importance. Where required, recruitment could be temporarily halted, or suspended and subjects discontinued. In ongoing trials, an increase in protocol deviations may arise during this time. It is important that such deviations are clearly documented (ref: ICH GCP E6 4.5.3) and there may be a requirement to have these deviations described in a separate section in Clinical Study Reports (CSRs) in the future.

Regulatory Activities of the EMA – The Agency’s overarching goal is to ensure that the assessment and monitoring of medicines are not disrupted and that patients in Europe continue to have access to high quality, safe and effective treatments during the COVID-19 outbreak. EMA continually reviews and adapts these measures as necessary.

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For companies preparing solutions for the novel coronavirus, we can help prepare emergency petitions for INDs, expedite submissions for new indications and apply for emergency use for drugs already in trials. How can we help you during this global health crisis? Please visit ProPharma Group’s global website: Novel Coronavirus Support or email your request to Info@ProPharmaGroup.com.


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