gan yakubutsu ryouhou senmon'i no nikki

shinyaku no shounin nitsuiteo hanashi taito omoi masu .

iyakuhin ha dokuritsu gyousei houjin iyakuhin iryou kiki sougou shinsa ( PMDA: Pharmaceuticals and Medical Device Agency, http://www.info.pmda.go.jp/ ) de shinsa wo uke , kousei roudou daijin niyotte shounin saremasu . waga kuni denoganni yuukou na shinyaku no shounin ga oubei yori okure teiru koto ha jijitsu desu . kinnen , shinsa . shounin suru gawa ha iyakuhin wo hayaku , anzen ni nippon no iryou genba de shiyoude kiruyouni ooku no doryoku woshiteimasuga , joukyou ga kaizen shiteiruyouniha kanji masen . kongo mokonoyouna joukyou ga tsuduku kotoga kenen saremasu . naze , nippon deha okure teirunokatoiu ten nitsuite , ikani shiken wo nobe masu . kono mondai ha kantan ni setsumeisu ru koto ga konnan natame , nankai kani wake te setsumeishi teikitaito omoi masu .

mazuha , waga kuni no shisutemu woo hanashi masu . seiyakugaisha ha shinyaku wo shihan suruniatatte , kuni no shounin wo ukeru hitsuyou gaarimasu . seiyakugaisha ga shinyaku wo hanbai shitaito kangae tatoki ,( kuni ni hanbai shitemoiidesuka ?) to ukagai wotatete , kuni ga ( iidesuyo .) toiuto shihan dekirutoiukotodesu . konotokini ( hanbai shitemoiidesuka ?) too ukagai wotateru tokini , seiyakugaisha ha shinyaku no kigen , kaihatsu no keii , kikaku . anteisei , dokusei , yakuri , yakubutsu doutai , rinshou jouhou nadowo shinsei shiryou toshite teishutsu shimasu . koreni taishi te , PMDA ha samazamana shinsa katei wo hete shinsahoukoku kaki wo sakusei shimasu . kono naiyou ni kanshi teha , jouki PMDA no homupeji de etsurankanou desu . kono naiyou wo miru to shitsu no takai shinsa ganasareteori , shinsa suru gawa hakanarino shigotoryou wo motome rareteirunoga yoku wakarimasu . saishuuteki ni shinsahoukoku kaki ga kousei roudoushou no yakuji . shokuhin eisei shingikai de shingi sare shounin saremasu .

kokode kiduka reru houga irassharuto omou nodesuga , seiyakugaisha ga ( hanbai shitemoiidesuka ?) too ukagai wotatenakereba shinyaku ha hanbai sarenaitoiu koto desu .( seiyakugaisha ha eiridantai desu . jizendantai dehaarimasen . tsuneni , rieki wo dasu saizen no houhou wo kangae teiruto omoi masu . konokotoha , gensoku toshite koutei shinakerebaikemasen . soudenakereba , seiyakugaisha no kaihatsu iyoku ga kyuusoku ni gentai surukotoninarudeshou . seiyakugaisha ha yoi kusuri wo kaihatsu shite , sono kekka , ooku no rieki wo ema su .) seiyakugaisha ga ( hanbai shitemoiidesuka ) too ukagai wotateru tokini , shinyaku ga ( donoyounaganni taishi te kouka gaarunoka ),( kouka gaarutosurebadorekurainanoka ),( fukusayou ha daijoubu nanoka ) nadono rinshou jouhou wo PMDA he teishutsu shinakerebaikemasen . konoyouna jouhou wo eru tameni seiyakugaisha ga okonau rinshou shiken nokotowo osamu ken to ii masu .( rinshou shiken nitsuitemo bekkou deo hanashi taito omotte imasu .) genjou toshite , seiyakugaisha ha , gaishikei no kaisha hamochiron nippon no kaisha deattemo , kaigai deno osamu ken wo yuusen saseteimasu . tsumari , waga kuni deha shinyaku kaihatsu no sutato jitende deokure teirutoiu koto ninarunodesu . naze , seiyakugaisha ha kaigai de kaihatsu wo hajime runodeshouka ? kono riyuu toshiteha ,( osamu ken no kuudouka ) toiu kotoba de houdou sareteiruyouni , osamu ken no shoyou kikan ga nagai , osamu ken no shitsu ga warui , osamu ken no hiyou gakakari sugi rutoiu osamu ken ni kansu ru mondai to shounin shinsa no kikan ga nagai toiu shinsa gawa no mondai ga age rare , kokunai deno osamu ken ga keien sareteimasu . sono hokani ha , kaisha no senryakuteki nakotomo age rarerudeshou .( tsuduki ha jikai nishitaito omoi masu .)

koremadeno kou gan zai tokorekarano kou gan zai nitsuiteo hanashi taito omoi masu . koremadeni kaihatsu saretekita kou gan zai ha , ganni taisuru sayou suru kijo niyotte , arukiru ka zai , shirogane seizai , taisha kikkou kusuri , binka arukaroido , takisan , topoisomeraze sogai kusuri , kou gan kouseibusshitsu nadoni bunrui saremasu . kou gan zai no kigen ha dainijisekaitaisen tokini doitsu de kaihatsu sareta doku gasu heiki dasoudesu . doku gasu heiki wo sekisai shita fune ga chinbotsu shita toki , sono jouin no hakkekkyuu ga genshou shiteitari , rinpa fushi ga ishuku shiteitarishitakotokara ketsueki noganni yuukou dehanaika kangae rare , naitorojienmasutado toiu arukiru ka zai ga kaihatsu saremashita . sono nochi , iroiro na kou gan zai ga toujou shitekimasu . idenshi dearu kakusan no gousei wo sogai suru taisha kikkou kusuri , dojou nakani iru hou sen kin ga tsukuru kou gan kouseibusshitsu , shirogane denkyoku no shuuhenbu niha sakkin sayou gaarukotoni chuumoku shi kaihatsu sareta shirogane seizai , shokubutsu yurai dearu binka arukaroido , takisan , topoisomeraze sogai kusuri ga kaihatsu saremashita . nichinichisou , ichii , ki ki nadono shokubutsu niha kou gan sayou noaru busshitsu ga fukuma reteitanodesu . korerano kou gan zai ha touyo ryou ga fue runi shitagatte kouka ga aga ruto kangae rareteimasuga , doujini fukusayou mo tsuyoku natteikimasu . sonotame , korerano kou gan zai no touyo ryou ha , fukusayou ga kyoyou dekiru jougen no ryou tonatteimasu .

kinnen ninatte sekkyokutekini kaihatsu sareteiru yakuzai ha bunshi hyouteki yakuzai desu . bunshi hyouteki yakuzai hagan saibou ni hatsugen shiteiru tokutei no tanpaku shitsu wo neraiuchi surumonode , kizon no kou gan zai toha sayoukijo ga kotona rimasu . kizon no kou gan zai ha , seijou na saibou mogan saibou noizurenimo dameji wo atae teshimai fukusayou ga mondai tonarimasuga , bunshi hyouteki kusuri deha tokutei no tanpaku shitsu ga hatsugen shiteiru saibou wo hyouteki nishiteirutame kizon no kouganzai yorimo fukusayou ga sukunai kotoga kitaisa remasu . ganno kenkyuu ga susumi , gan saibou ga zoushoku shiteiku shikumi ga kaimei saretekimashita . konogan saibou no zoushoku nihasamazamana tanpaku shitsu ga kanyo shiteimasu . bunshi hyouteki yakuzai hakonoyounagan saibou no zoushoku ni kakawa ru tanpaku shitsu wo hyouteki shiteimasu . kouganzai no kaihatsuhouhou mo kawa ttekiteori , koremadeno kouganzai ha shizenkai ni sonzai shiteiru busshitsu kara , ganwoyattsukeru busshitsu wo tansaku shiteimashitaga , genzai ha hyouteki nishita tanpaku shitsu wo sogai surukotoga dekiru busshitsu wo ooku gousei shi , kono naka kara kouka gaarumonowo pikkuappu shitekimasu . bunshi hyouteki yakuzai toshitesudeni shihan sareteirumononi , ritsukisan , guribekku , hasepuchin , iressa , abasuchin , berukedo ga age raremasu .( kokodeha shouhinmei de kisaishi teimasu .) bunrui suruto ritsukisan , hasepuchin , abasuchin ha koutai iyakuhin deari , guribekku , iressa ha chiroshin kinaze no sogai zai , berukedo ha puroteasomu sogai kusuri desu . bunshi hyouteki yakuzai ha kongo no kagi tonaru yakuzai desu . kongo , kuwashiku o hanashi teikitaito omoi masu .