Every year, a small number medicinal products receive marketing authorisation or a product licence. However, in their wake several thousand drug candidates fall by the wayside. The discovery and development journey through to the approval and marketing stages of these successful candidates as we know it can take over 12 years and often much longer and costs approximately $2.6 billion (Sullivan, 2019). Prior to the regulatory authorities granting a marketing authorisation or product licence, the sponsor is required to provide a dossier that includes relevant administrative, quality, nonclinical and clinical data. In addition, both the EU and US regulatory bodies require preclinical testing of the drug to be marketed and three clinical trial phases among the drug development process. These are lengthy, complex processes and in most cases patient access to medicines in a timely manner is very challenging. With this in mind, both the EU and US regulatory authorities have adopted new initiatives which aim to make the availability of certain therapies accessible to patients in an expedited manner. Many of these initiatives focus on therapies that address unmet clinical needs. These initiatives are also available for many Advanced Therapy Medicinal Products (ATMPs). However, as of October 2020, only 15 ATMPs have been approved in the EU in the last decade with five of them withdrawn from the market. In addition, only 14 such therapies have been approved in the US. There have been some improvements since the commercialisation of the first ATMP yet many hurdles remain which have limited and will continue to limit the availability of safe, efficacious high quality products in a timely manner to patients in much need of these promising therapies.
Warreth, Shada and Harris, Elaine
"The Regulatory Landscape for ATMPs in the EU and US: a Comparison,"
2, Article 5.
Available at: https://arrow.tudublin.ie/level3/vol15/iss2/5
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