E-drug: Policy process on re-evaluation of drugs
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Dear Friends,
I am reviewing a literature on pharmaceutical re-evaluation policy
especially on policy process experiences of various countries.
Unfortunately, there are not so many papers on this issue in Med-line
or equivalent CD-ROM Databases. To my opinion, very few developing
countries have success in implementing this policy even though new drug
registration system is in operation. So, drugs registered under the old
system are still available in the market without having been properly assessed.
My definition for re-evaluation is:- the process of re-assessment of
the whole lot of `old drugs' registered with the old system before
entering new drug approval or NDA. Some countries might use other
terms such as `review' in case of UK or `re-examination' in Japan.
This policy differs from the routine and ongoing process of PMS or
re-assessment for renewal of product licence, which also is another
interesting topic.
Any comment or suggestion is most appreciated. Please send reply
directly to me and report will follow very soon for more discussion.
Thanks,
Niyada
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Niyada Kiatying-Angsulee
PhD Student, Health Policy Unit,
London School of Hygiene&Tropical Medicine
LONDON, WC1E 7HT, UK
TEL. +44-(0)171-9272146
FAX. +44-(0)171-6375391
email: phpunkia@lshtm.ac.uk
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