Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και Πρόσβαση
Library of the School of Health Sciences

2021-01-14

2021

Karathanasi Maria

Κωνσταντίνος Ν. Συρίγος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Ανδριανή Χαρπίδου, Διδάκτωρ, Ιατρική Σχολή, ΕΚΠΑ
Ηλίας Κοττέας, Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ

Διαδικασίες ταχείας έγκρισης (fast track) νέων φαρμάκων σε Ευρώπη και Β. Αμερική: ρυθμιστικό και κανονιστικό πλαίσιο

Greek

Fast track approvals of new drugs in Europe and USA: regulatory framework

The European Medical Agency (EMA) and the Food and Drug Administration (FDA) have their own structure and regulatory framework but both have as main priority to assure the public health and to provide safe and effective medicinal products in high quality to the public. For these reasons, there are well-defined criteria and human drugs must meet high quality standards for their approval. This is related to drug development and review processes consisted of many different stages that require time to complete. However, this is a main challenge for drugs whose aim is to treat rare diseases, an unmet medical need or a serious life-threatening disease because there is immediate need for early access to innovative therapies.
EMA and FDA must deal with the dilemma of the so-called “access-versus-evidence” question. In response, regulators have created programs and specific “designations” to expedite approval of promising new drugs. Some of these procedures aim to accelerate the development while others shorten the review time of approvals.
The aim of this thesis is to analyze the expedited programs in Europe and the North USA, the regulatory guidelines which support these programs and to present their similarities and differences. At first place each program or designation will be further analyzed, the threshold criteria and the possible post market issues. After that, a comparison between EMA and FDA is presented in a separate chapter, based on the official data, the annual reports and published studies. From this comparison it was clear that there are some common points but the frequency and the way the two agencies use these programs is different.
In conclusion, it is obvious that there is a growing demand for early access of innovative drugs and the proper balance between this need and the evidence at the time of approval is a challenge that both agencies must overcome.

Health Sciences

EMA, FDA, Fast track approvals, Expedited programs

No

0

Yes

112

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https://pergamos.lib.uoa.gr/uoa/dl/object/2932489