May 17, 2010 09:40
14 yrs ago
3 viewers *
English term
GEKAMON (X)
marketed use vs market experience
English
Medical
Medical: Pharmaceuticals
licensing
Could anyone explain the difference between marketed use and market experience in the following context:
Traditionally, NRAs have required the use of a nationally licensed reference product for licensing of generic medicines. This practice may not be feasible for countries lacking nationally-licensed RBPs. NRAs may need to consider establishing additional criteria to guide the acceptability of using a RBP licensed or resourced in other countries. The use of reference products with proven efficacy and safety in a given population will be one of the factors to consider. Another parameter may be market experience in addition to the duration and marketed use.
RBP should have been marketed for a suitable duration and have a volume of marketed use such that the demonstration of similarity to it brings into relevance a substantial body of acceptable data regarding the safety and efficacy
Does marketed use means volume of sales?
Thanks in advance!
Traditionally, NRAs have required the use of a nationally licensed reference product for licensing of generic medicines. This practice may not be feasible for countries lacking nationally-licensed RBPs. NRAs may need to consider establishing additional criteria to guide the acceptability of using a RBP licensed or resourced in other countries. The use of reference products with proven efficacy and safety in a given population will be one of the factors to consider. Another parameter may be market experience in addition to the duration and marketed use.
RBP should have been marketed for a suitable duration and have a volume of marketed use such that the demonstration of similarity to it brings into relevance a substantial body of acceptable data regarding the safety and efficacy
Does marketed use means volume of sales?
Thanks in advance!
Responses
| 4 +1 | pls see below |
Natalie
|
Responses
+1
18 mins
Selected
pls see below
Market experience means the experience of the drug use after it has been registered/allowed for retail.
Marketed use means drug use after it has been registered and allowed for retail.
All this is necessary for post-market control and pharmacovigilance, see, for example, http://www.fhb.gov.hk/download/press_and_publications/otheri...
PHARMACOVIGILANCE
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Note added at 21 mins (2010-05-17 10:01:51 GMT)
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Post market safety surveillance
After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days; other events on a quarterly basis.[13] The FDA also receives directly adverse drug event reports through its MedWatch program.[14] These reports are called '"spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases the FDA requires risk management plans for some drugs that may provide for other kinds of studies, restrictions, or safety surveillance activities.
http://en.wikipedia.org/wiki/Food_and_Drug_Administration#Po...
Marketed use means drug use after it has been registered and allowed for retail.
All this is necessary for post-market control and pharmacovigilance, see, for example, http://www.fhb.gov.hk/download/press_and_publications/otheri...
PHARMACOVIGILANCE
--------------------------------------------------
Note added at 21 mins (2010-05-17 10:01:51 GMT)
--------------------------------------------------
Post market safety surveillance
After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days; other events on a quarterly basis.[13] The FDA also receives directly adverse drug event reports through its MedWatch program.[14] These reports are called '"spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases the FDA requires risk management plans for some drugs that may provide for other kinds of studies, restrictions, or safety surveillance activities.
http://en.wikipedia.org/wiki/Food_and_Drug_Administration#Po...
4 KudoZ points awarded for this answer.
Comment: "Thank you very much!"
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