Early Access Program
Early Access Program ( EAP ) is the English term for programs that enable early access to drugs , but which have not yet been approved . They are used by a growing number of pharmaceutical companies because of various advantages of these programs. EAPs provide ethical, compliant, and controlled processes for patients with life-threatening diseases for which treatment options have not yet been available for access to investigational drugs outside of clinical trials and prior to the drug's commercial launch.
background
Following the recent Ebola virus outbreak in West Africa, the World Health Organization issued a statement indicating that it is ethical to give patients in need access to investigational drugs that have not been approved by the authorities or have not even been tested in humans contain the epidemic and save patients' lives.
Regulatory conditions
The legal requirements for EAPs vary from country to country and are very strict.
See also
Web links
- FDA : Expanded Access to Investigational Drugs for Treatment Use
- EMA : Questions and answers on the compassionate use of medicines in the European Union
- G. Balasubramanian, S. Morampudi, P. Chhabra, A. Gowda, B. Zomorodi: An overview of Compassionate Use Programs in the European Union member states. In: Intractable & rare diseases research. Volume 5, number 4, November 2016, pp. 244-254, doi : 10.5582 / irdr.2016.01054 , PMID 27904819 , PMC 5116859 (free full text) (review).
- mytomorrows.com
Individual evidence
- ↑ Ethical considerations for use of unregistered interventions for Ebola virus disease , Report of an advisory panel to WHO, accessed February 17, 2020
- ↑ Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers , FDA guideline, accessed on February 17, 2020
