IFPMA published a compendium of requirements for worldwide regulatory
submissions a few years back but I am not sure that this has been kept up to
date. Try contacting IFPMA.org .
Regards,
Brian Matthews
lt09@dial.pipex.com
Quoting gfarmer@scotia-holdings.com:
>
> Does anyone have, or know where I could access a comprehensive list of
> the
> various requirements for submissions in Latin America, Eastern Europe,
> Middle and Far East. By comprehensive, I mean details on, for example,
> the
> need for local clinical trials, if the studies must be ongoing or
> complete
> at time of submission, the need for and timing of delivery of samples,
> local agent requirements, submission fees, likely time of approval,
> local
> language requirements for the various parts of the dossier, the timing
> of
> the certificate of free sale (needed for submission or can be provided
> prior to approval) etc
>
> many thanks
>
> Gerard Farmer
>
>
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