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.
With the shortest possible timeframes, the agency is fully mobilized to deliver certain fast-track procedures as detailed below.
Reduced R&D timeframes: Contextual to COVID-19 and assisting product development during the research & development phase, EMA reduced the scientific advice procedure time to 20 days from regular 40-70 days and waived its fees. The Paediatric Investigation Plans (PIPs) review time is shortened to 20 days from normal 120 days, with 4 days of rapid PIP compliance check prior to marketing authorization submission. EMA explains, the scientific advice will be provided depending on the number and complexity of the requests and on the availability of resources in the public health threat situation of COVID-19.
Quick review & approval: EU’s standard time period for evaluating a medicine is 210 days. However, referring to the current pandemic, EMA has announced expedite rolling review and accelerated assessment procedures for COVID-19 related products. Several rolling review cycles are carried out for evaluating one product and each cycle is expected to take around two weeks, depending on the data availability. The accelerated assessment procedure reduces the review time from 210 to less than 150 days.
Compassionate use programs: The individual EU Member States set up compassionate use programs, allowing patients to access the treatments that are still under development and did not receive marketing authorization. EMA can provide scientific recommendations on how these medicines should be used in this context.
To accelerate every step of product evaluation one should adhere to the addressed EMA relaxed regulations. At this emergency hour, go for hassle-free and compliant market entry with adept Regulatory assistance. Stay safe. Stay informed. Stay compliant.