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Read the article:Application of orphan drug designation to cancer treatments XXXXXXXXXX): a comprehensive and comparative analysis of the USA and EUDownload Application of orphan drug designation to cancer treatments XXXXXXXXXX): a comprehensive and comparative analysis of the USA and EUWhat are the similarities and differences between the US FDA system and the EMA in terms of classification of orphan drugs?How do the differences between the systems impact the development of drugs on both regions?Discuss your point of view in terms of the implications for clinical development

Dr. Urooj · Accepted Answer

ORPHAN DRUG	3
ORPHAN DRUG
ORPHAN DRUG
An orphan drug is defined as a drug that is used to treat, fend off or determine an orphan disease. An Orphan disease is a disease that is very uncommon that affects fewer than 2 lack people in the US. These diseases are usually serious and fatal threatening to life. The 1983 act, the Orphan Drug Act has been made to assist the pharmaceutical companies with finances for developing orphan drugs which can be used safely and efficiently for patients. (National Cancer Institute NCI)
1. The similarities and differences between US FDA and EMA in terms of orphan drugs classification.
a) The collaboration of FDA and EMA:-
In order to reduce the management burden and to uplift the drug submissions to both FDA and EMA, a joint appeal form was submitted in 2007 in UNITED STATES and the EUROPEAN UNION. They are working in conjunction to comprehend the orphan drugs and their development. The evaluation for the FDA is been done by OOPD Drug Designation Program and for EMA, it is done by Committee for Orphan Medical Products (COMP).
b)Medical credibility and research based principles:-
Both the organizations need benefactor’s data to hold up the hypothesis that a particular drug has potential effect and pharmacologically active and development of such product would benefit the human race.
The introductory surveys done by both the organizations shows that about 30% of the capitulation use preclinical in vivo details and the remaining has the favorable pharmacological data in use for patients based on their conditions. A mere percentage of tolerable medical plausibility areas have the details limited to in vitro. (Mariz.S 2016)
c) The Ubiquity:- The US FDA considers a disease as an orphan only when its occurrence is in fewer than 2 lack people where as EMA considers it as an orphan disease when the occurrence is in not more than 5 in 10 thousand people.
d)The substantive procedural facet:-In the EMA ,after a submission is made then a time period of 90 days are allocated with no in between clock stop period where as there is no time limit in terms of FDA law although the FDA OOPD works to attain a timely progress and completion of the work and submission of it to sponsors.  (Mariz.S 2016)
Additionally EMA sees whether the drug which is been studied  is worthy enough to spend so much finances on it,

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