proposed amendment of the regulation on pharmaceuticals approval notification and review 47 pages available in korean - preparations that can be taken without water orally disintegrating tablets are taken from the category special preparations and moved to general preparations. - establish standards for the evaluation of safety and efficacy of preparations administered through the inhalation of active drug substances etc. so that they are internationally harmonized. - improve the management of approval for active drug substances with different hydrates that function equally in the human body. - exclude ester derivatives of already approved drug substance s from the new molecular entity category if it is identical to an approved drug when orally taken and degraded in the digestive organs. - streamline the approval process for imported pharmaceuticals that have previously withdrawn their domestic approval - acknowledge multiple specifications for an active substance in case of pharmacopoeia specification - mandate gmp evaluation in the approval process of pharmaceuticals intended for export. - allow a separate approval process for pharmaceuticals intended for export. - rationalize the domestic approval process for foreign new drugs by improving the scheme in deciding whether to perform bridging studies. - abolish mandatory notification of drug substances specification in the certificate which verifies the imported drugs certification for manufacture and marketing in the originating country. - mandate the submission of ctd for approval for generic drugs. - mandate the submission of data that proves the non-addition of harmful substances that originated from the container. - strengthen safety management regulations for manufacturing processes of animal-derived pharmaceuticals. - in addition to bioequivalence study secure a method to ensure credibility of pharmacokinetics data audit-trail of phase 1 clinical trial - mandate stability test report submission of generic drugs. - improve the display presentation of posology method of administration for pediatric drugs. - introduce a method to provide professional approval information for experts doctors pharmacists etc - provide 4-year exclusivity for pediatric drugs with added new indication or posology method of administration and orphan drugs whose efficacy and safety have been verified by domestic clinical trials. - mandate the submission of verification data on microorganism specification in approval processes of probiotics. - strengthen quality evaluation of subdivided pharmaceutical ingredients.