draft amendment of ministerial ordinance of the pharmaceutical affairs act 28 pages in korean when applying for approval of biological products etc. review data to prove its safety and efficacy shall be submitted. when applying for approval of generic drugs in the form of tablets capsules and suppositories that are prescription drugs the protocol to establish their biological equivalence must be submitted. subject to the guidelines on reporting of imported raw pharmaceutical materials all expenses for on-site inspection in the origin countries will be borne by their importers. obligations and observances required of quality assurance agencies on pharmaceuticals etc. have been reinforced. for pharmaceuticals subject to re-examination to the kfda manufacturers or importers will be required to submit a protocol on the clinical experience and report on the progress of annual surveillance. manufacturers and importers will be obligated to operate a voluntary recall system for defective pharmaceutical products. the commissioner of the kfda korean food and drug administration is authorized to establish provisions for special packing of pharmaceuticals so as to prevent drug-related accidents caused by children. manufacturers or importers are required to produce or import and supply pharmaceuticals in small quantity packagings besides economy-sized ones as provided for by the commissioner of the kfda besides economy-sized ones. legal grounds will be established for manufacturers to purchase pharmaceuticals produced by other manufacturers for the purpose of developing new products. for biological substances the relevant regulations on manufacturing and marketing shall be separately specified. pharmaceuticals wholesalers and retailers are obligated to report any unauthorized or illegal products that they become aware of. however when they are manifestly found to be irrelevant to the obligations legal punishment will be relieved or exempted by the regulation. the provision allowing pharmaceutical wholesalers at the initial stage of separation policy between prescribing and dispensing to sell pharmaceuticals in open packagings has been deleted. for pharmaceuticals separately designated by the commissioner of the kfda the name of additives shall be clearly written on the external packets by the manufacturers and additional regulations will be added hereto as necessary. detailed provisions will be established for using electronic money to pay for drug related service charges