News & Event

[2012. 06] KFDA announces proposal for reclassification of medical items

Date2012.08.09 View351


Last 5th of June KFDA announced the
proposal for reclassification of medicines.

This proposal reflects changes in health care environment including
the late scientific and technological advancements, aiming to achieve after and
more rational use of medic
ines.  With references to safety and efficacy assessments
as well as current states of developed countries, the proposal re-evaluates and
reclassifies 39,254 currently approved medic


According to the proposal, change would cover 526 items, which constitutes 1.3% of the total. This list includes reclassification from OTC to prescription-only
of 60 major items (total 273), from prescription-only to OTC of 42 major items (total 212), and concurrent classification
of 40 prescription drugs and one OTC drug.


In terms of emergency contraceptive medicine, 11 out of 12
prescription drugs including
Levonogestrel are
reclassified to OTC, while the other remains prescription only. Start of a controversy
has been spotted where 9 OTC drugs out of 11 total contraceptives have been
proposed to be reclassified prescription only
because the
value of
contraceptives reflects not
the scientific physiological basis but also the
value of social abou
t contraception.


KFDA plans to adopt Drug Permission Renewal System, which will allow periodic
reassessment of classification of drugs every 5 years, as well as to offer
classification process upon receipt of reclassification request from consumer
the groups of healthcare
providers including pharmacists
, etc.