EMA’s Accelerated Regulatory Mechanisms for COVID-19 Products

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EMA’s Accelerated Regulatory Mechanisms for COVID-19 Products

In the face of COVID-19 emergency, the European Medicines Agency (EMA) established faster scientific advice, rolling reviews and accelerated assessments to expedite the development and approval of medicinal products. EMA’s foresight is to support the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines at the earliest.  As claimed, EMA adapts rapid procedures to significantly cut-short the Regulatory timelines for the review of new medicines and vaccines against COVID-19.

SFDA’s Recognized Standards and Requirements for Ventilators

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SFDA’s Recognized Standards and Requirements for Ventilators

With the wider spread of COVID-19, there is a raising alarm for ventilators shortage. Pursuant to the situation, Saudi Food and Drug Authority (SFDA) devised guidance for quick market entry of ventilators and its accessories, within KSA (Kingdom of Saudi Arabia). The guidance specifies the requirements and recognized standards to obtain the Medical Devices Marketing Authorization (MDMA) for ventilators, ventilator tubing connectors, and ventilator accessories.