E-DRUG: Protocol For Post marketing Surveillance?
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Dear All,
I am interested to know the protocol to conduct Post marketing surveillance
studies for drugs or vaccines.
I want to know wether it varies from country to country.
Many thanks in advance
Sincerely
Reddy Nandan
Reg Affairs
India
trnr_reg@hotmail.com
[easy question, difficult answer. There are no WHO guidelines for PMS, I believe? ICH may have some (see www.ich.org) but they are targeted for rich countries (USA, EU, japan). Low-resource countries often have problems registering drugs, and PMS is even more difficult. Conditions to do PMS are normally set during registration. Obviously there are WHO guidelines for pharmaco-vigilance, but that is not what you are looking for? Which countries did you have in mind? WB]
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