RHY 0.00% 5.8¢ rhythm biosciences limited

TGA /FDA/EMA/MHRA

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    For a drug / diagnosis technique / medical device to be qualified to use safely and, effectively in UK, a license must be issued by Medicines and Healthcare Products Regulatory Agency (MHRA).

    In wider Europe, a European Medicines Agency (EMA) licence, is a must.

    Similarly, FDA accreditation for USA and TGA for Australia.

    So UKCA and CE Mark are not a qualification to recognise the safety and effectiveness of a drug, diagnosis technique or medical device.

    References

    https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

    https://www.ema.europa.eu/en
 
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