Modernizing Regulation of Non-Prescription Medicines Through Increased Flexibility and Digitalisation

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Non-prescription medicines typically treat self-limiting conditions and prevent diseases—they are a critical component of an efficient and effective healthcare system. To ensure that non-prescription medicines continued to be available as an important option for consumers during the pandemic, regulatory authorities and the self-care industry took unprecedented actions, including increased collaboration and communication among regulatory authorities and between authorities and manufacturers. Many regulatory authorities also adopted policies, regulations, and processes to ensure continuity of critical medicines supplies.

For instance, some regulatory authorities reacted to the COVID-19 crisis by initiating risk-based approaches to simplify and streamline regulatory practices. This included postponement of certain pre-market requirements and scheduled lifecycle management obligations or expedited riskbenefit reviews as well as digitalising agency practices and requirements. Among the simple solutions were the acceptance of digital instead of wet signatures by EMA, which started to issue electronic certificates for medicinal products (eCPPs). This ensured that EMA could provide certificates during the COVID-19 pandemic without any business disruption facilitating the regulatory compliance and timely access for medicines in importing countries.