KFDA announces proposal for reclassification of medical items

Reference:  http://eng.kpanet.or.kr/bbs/desc.jsp?cat=eng_news&oid=17782&pg=0


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 medicines.  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 medicine-items.


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 
only the scientific physiological basis but also the 
value of social about 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 
groups, the groups of healthcare 
providers including pharmacists, etc.