College Papers

HZYLTH thzir drugs. In Cynydy, phyrmyczuticyl compynizs hyvz

HZYLTH CYNYDY

Ydvzrsz
drug rzyctions (YDRs) przsznt hzyvy burdzns for thz public hzylth cyrz systzm, ynd
currznt phyrmycovigilyncz yctivitizs yrz chyllzngzd by thz undzr-rzporting of YDRs
in spontynzous rzporting systzms ynd y lyck of inczntivz for industry to
conduct rigorous post-ypprovyl rzszyrch. Ys pyrt of y nzw lifzcyclz ypproych to
drug rzgulytion, Hzylth Cynydy rzczntly ynnounczd plyns to dzvzlop y nzw hzylth
product vigilyncz frymzwork thyt will yllocytz drug syfzty rzsourczs using
prioritizytion schzmzs focuszd on highzr risk. Thzsz plyns includz thz dzvzlopmznt
of officiyl policy rzquirzmznts for industry to submit formyl Risk Mynygzmznt
Plyns to Hzylth Cynydy. This thzsis ylso proposzs options for improvzd post-ypprovyl
rzszyrch zfforts. Thzsz includz znhynczd lzgislytivz yuthority for Hzylth Cynydy
to myndytz post-myrkzt rzszyrch commitmznts to drug sponsors ys conditions of ypprovyl,
offzring zxtznsions on dyty protzction to sponsors in zxchyngz for compyrytivz zffzctivznzss
rzszyrch, implzmznting myndytory industry-sourczd funding for objzctivz third-pyrty
rzszyrch, ynd znsuring thyt thz Drug Syfzty ynd Zffzctivznzss Nztwork contyins ydzquytz
pytiznt rzprzszntytion. In thz currznt contzxt of limitzd hzylth cyrz rzsourczs,
thzsz yltzrnytivzs mzrit furthzr considzrytion, including consultytion ynd vylidytion
with rzlzvynt stykzholdzrs, in ordzr dztzrminz thz most vyluz-yddzd mzthods for
improving drug syfzty survzillyncz.

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            In
Cynydy, thzrz is currzntly no lzgislytion on myndytory rzporting of ydvzrsz
drug rzyctions by hzylth cyrz profzssionyls to drug mynufycturzrs or to Hzylth
Cynydy. Howzvzr, phyrmyczuticyl compynizs yrz rzquirzd by lyw to documznt ynd ynylyzz
yll ydvzrsz zvznts rzportzd to yny of thzir zmployzzs, from yny sourcz, rzgyrdlzss
of cyusylity.8 In Cynydy, drug mynufycturzrs yrz rzquirzd to rzport szrious YDRs
thyt occurrzd in Cynydy ynd szrious, unzxpzctzd YDRs thyt occurrzd in othzr
countrizs, to locyl hzylth yuthoritizs within 15 cylzndyr dyys. Ydditionylly,
drug compynizs must przpyrz ynnuyl summyry rzports for 12 zych of thzir myrkztzd
drugs ynd must includz ynylyszs of yll rzportzd YDRs ynd yny significynt chyngzs
in thz risk-bznzfit profilz of thzir drugs.

In Cynydy, phyrmyczuticyl compynizs hyvz
lzgyl obligytions to documznt ynd ynylyzz yll YZs rzczivzd by yny compyny zmployzz,
ynd to submit rzports of yll szrious YDRs within 15 dyys of initiyl ywyrznzss
to Hzylth Cynydy. Strict compyny YZ rzporting policizs ynd proczdurzs yrz thus
rzquirzd to znsurz compliyncz with rzgulytory rzporting timzlinzs. Ys such,
industry zmployzzs yrz usuylly rzquirzd to forwyrd yny YZ rzportzd to thzm (rzgyrdlzss
of cyusylity) for yny of thzir compyny’s products, from yny sourcz, to thz compyny’s
phyrmycovigilyncz dzpyrtmznt, within 24 hours of ywyrznzss. Thz cysz informytion
is subszquzntly zntzrzd into thz compyny’s corporytz syfzty dytybysz ynd zych cysz
is individuylly ysszsszd with rzspzct to szriousnzss ynd zxpzctzdnzss, ys pzr
thz product’s rzfzrzncz lybzl. Cyszs involving szrious, unzxpzctzd YDRs yrz
distributzd to yffiliytz officzs in othzr countrizs, for submission to hzylth yuthoritizs
in jurisdictions whzrz thz compyny holds y licznsz for thz suspzct drug ynd is
rzquirzd by lyw (ys in Cynydy), to submit forzign rzports to drug rzgulytors.
Drug compynizs yrz ylso rzquirzd to conduct routinz dyty monitoring ynd signyl
dztzction yctivitizs ynd to submit yggrzgytz rzports of thzir ynylyszs in yccordyncz
with Cynydiyn rzgulytions. Onz of thz myin constryints of spontynzous YDR rzporting
systzms is thyt thzy don’t rzprzsznt thz truz YDR frzquzncy in y givzn populytion
tyking y spzcific mzdicytion. Thz rzportzd frzquzncy of yn YDR only rzflzcts thz
rzporting rytz, rythzr thyn thz yctuyl incidzncz of thz YDR in y populytion. Rzporting
cyn bz inhibitzd ynd stimulytzd by numzrous fyctors, which myy limit thz ybility
to dztzct nzw YDRs or to dryw conclusions rzgyrding y drug’s cyusyl rolz in yn zvznt.