KFDA Inspection Program for Quality and Compliance Efforts. Young-Ok Kim Clinical Trials Management Div. Korea Food and Drug Administration

Transcription

1 KFA Ip Pg f Qy d Cp Eff Yg-Ok K C T Mg. K Fd d g Ad

2 CONTENTS 1 Id C Rgy b f K KFA p (C ) 2011 p p 5 Sgh h p f g If A 2

3 1. INTROUCTION INTROUCTION g If A 3

4 KOREA FOO AN RUG AMINISTRATION Pg h pb hh by g h fy d ffy f fd, ph, d d d, d ppg h dp f h fd d ph d. Th g gy d pg d pg h pb hh Sghg g M P d p hh hgh h f g y d ghg p V C hghy gbzd f f d g-dd y g If A 4

5 KFA Ogz (Ap. 2009) C p y C P g & C d R k P P y B R k P P y. R k I f. L b y A d & P y. C T M g. F d S f y B P h S f y B N C. P h Q y. P h M g. h S f y P y g E p p h & H b M d B B p h P y. H b M d P y. C P y. H b M d E p. M d S f y B d E p. M d P y. M d M g. M d Q y. G S C I g O f f A d & I p O f f S p k p N I f Fd d g Sfy E 6 Rg KFA Off g If A 5

6 C T d f KFA Ad Rp Ip App KFA Ad g - Ph 0 - Ph Ph 4 - IIT -Egy Bg/Hb Md - Ph 0 - Ph Ph 4 - IIT - Egy Md - C Hh f fd/f - T f h g If A 6

7 IN App K KFA db N M S g If A 7

8 2. Rgy B f C T K REGULATORY BASIS FOR CLINICAL TRIALS IN KOREA g If A 8

9 Rgy If Rgy hhy f Ph Aff Lw (A 34) Md Lw (A 10) Ef Rg f Ef Rg f Ph Aff Lw Md Lw (A 31, 32, 33, 34) (A 12 & 13) - Gd f GCP - Gd f IN - Gd f Add C I - Gd f GCP - Gd f IN - Gd f Add C I C ff f gz pp hz f d g dd KFA fd 1998 g If A 9

10 M f KGCP 1987 Ebh f KGCP (d) 1995 Rq f p f KGCP 1999 Adp f h Bdgg Cp (E5) 2000 Hzd wh ICH gd E6 Ebh f Ph A A 26-4 ( hgd A 34) - p h gh d fy f bj - fy h pby f g - f h f f IRB 2002 Id f IN -Sp bw dp g d pd pp, IN d NA - Pp dy y g 2006 KFA C g bh 2007 Mg f j IRB f Shd w pd f ph 1 (hhy ) g If A 10

11 Ow f C T Ad-E Rp Pp Ig ㆍ W Sdy Rp ㆍ S Sdy Sbj Ig Ad P Sb Ad- E(SUSAR ) p Sp ㆍP ㆍP Sd ㆍCp ㆍSdy Mg ㆍ Ad P Sb C Ip KFA ㆍ P pp ㆍ Ip ㆍ I d ㆍ Sdy Rp ㆍ Ad-E Rp f Ig S ㆍ IRB ㆍ Ebh f SOP ㆍ C Ad Off ㆍ S Ad ㆍ P P Rgh ㆍ M C T d Ip W Ifd C P IRB g If A 11

12 Ow f Ig d C T Ad-E Rp Pd g / Md d P Sb Ad-E Rp Pp Ig ㆍ W Sdy Rp ㆍ S Sdy Sbj ㆍ Cp ㆍ Sdy Mg ㆍ Ad Ig ㆍ Sdy Rp ㆍ Ad-E Rp P Sb f Ig S ㆍ IRB ㆍ Ebh f SOP ㆍ C Ad Off ㆍ S Ad ㆍ P P Rgh ㆍ M C T d Ad W Ifd C P IRB KFA - P pp Ip g If A 12

13 Gd Add C I ff 1997 (dg) & 2006 (d d) A h qy f dg h q d qfy 1997(dg) & 2006(d d) Wh y b dd? Appp f d qp P f p pp h dy P IRB d Ed pg (KGCP) If f h g g If A 13

14 3. KFA Ip KFA S INSPECTIONS (CLINICAL TRIALS) g If A 14

15 Obj f Ip KFA p p d dd : - T p h gh, fy, d wf f bj d K - T fy h gy d by f d bd KFA pp f h/na - T f p wh h p d h g, gd d dd pg pd f Sp f p - S : C Ig, IRB - Sp : C Rh Ogz (f ppb), M g If A 15

16 KFA Ip Ip yp - Shdd(Rg) p - Uhdd(d) p f- Ip gy - Ip f -gg d pd - S f bd h k p d IIT p ph Pd yp (NCE, Rb pd, C hpy, g hpy, h) Cpxy f h dg Sbj Thp d Sdy pp (pd, h b, g) S xpd d dg h g If A 16

17 Ip Typ <Rg Ip> Tg Ip C Pd A Sp A dd ('07: b f 70) ('08: b f 43) ('09: b f 35) M h w p Ff f g O, O, N h 5 dy (p d b pppy hgd wh qd) g If A 17

18 Ip Typ <d Ip> Ef g f PAL A 32 / ML A 13 d KGCP p p A p Sfy p Cp p E - F bj gy - A p d pg f - T p - SAE p Idd SUSAR.g. h. - Rby f f p bd h KFA pp f NA - C p - Cf f p d k-bk d dd f IMP g If A 18

19 Ip P P Ip g Ip Af Ip 2 wk ~ 10 dy 1 ~ 5 dy 2 wk Pp Pg C bfg Fw-p g p (f p p pp h p) d ff b f IRBppd p Ip f w bkgd (.g., dy p, fd d, CRF) w p d b wh ff d f pg f y d fd dg p z d p f fdg fy h fdg g fy pp pd (Wg L N ) g If A 19

20 Ip P - Pp Pp Th A p p dpd d fzd by KFA Th p d gd d fd wh h p A N f p h p f h b pd wh 10 dy p h ppd d() f p Th p hd b L f ppd p by IRB KFA wh 5 dy f p f h N f p - T h d d q g d f p Chk- f p g, IRB d p h b pbhd gd h d khd f pp f KGCP p g If A 20

21 Ip P g Ip g Ip Opg Mg wh ky ff Fy T - V dg g & by & hg Rw - Sdy f f d, fd d - d d CRF - g by - Mg p - d Lby Iw wh dy ff d p Chk h d pb f dy ff g If A 21

22 Ip P g Ip g Ip Cg g f p - Thk ff f h p d f h p - Exp wh w wd dg h p - Exp p p f dy d h - dfd d fdg dg p - Exp gf fdg d - Mk g wh dy ff - F p d d h p g If A 22

23 Ip P Fw-p Fw-p A Ip p f h fdg d p wh 2 wk f p Th p hd b h C A d P A P KFA wh 30 dy f p f h p p O h C A d P A P dd b dq, p w b d. Appp w b k f -p dd g If A 23

24 Cf f p fdg V (C) A gf h p pb k - Cd, p p h dy ff h gh, fy w bg f h bj d/ h qy d gy f d - Id z f p f h pb d p qd h - Tk d dg h Ph ff Lw f y C (Mj) A h p h h p p hgh k - Cd, p p h gh dy ff h gh, fy w bg f h bj d/ h qy d gy f d - Rz f h pb d p qd h - C (Spp ) qd b bd KFA - Add p y h qd d fy bd (.g., p d/ d) g If A 24

25 Cf f p fdg C (M) A h p h h p p d k - Cd, p p h wd b xpd dy ff h gh, fy w bg f h bj d/ h qy d gy f d - Rz f h pb qd b d - P d p hw p qy d/ d h p f d h f Rd Th b h gh gg hw p qy d/ d h p f d h f - Pd wh fh g If A 25

26 Cf f p fdg - A A f - C f d d h g d g. Vy y. Oy, h q p f h IRB A wg - C f d d h g d g. A wg gy q pp d f w p KFA g If A 26

27 Ip 2011 INSPECTION PLAN g If A 27

28 2011 Ip P - Obj Ebh dd f p p pb Ip by f p qy Ebh p SOP f p C y fy g y Op h f f p(d d p) pb f pp h d b pd Ebh Ip Q&A I d Ebh y p SOP f Sgh h bj p by pdg f h bj Ip ICF d f bj Ip IRB pp f bj d bf dg Ip bg f g dg g If A 28

29 2011 Ip P - Tg Tg Rg(hdd) p Add d(hdd) p Sp, dd I Vy p Id d pfd by dd g If A 29

30 2011 Ip P Rg Ip Rg(hdd) Ip T/h 62 dd 58 dd f dg 27 dd f d d 23 dd f bh dg d d d I 22 h b pd f 3 h b pd d hy f dg Ex 55 pd 09, pd 09, 10 d h f p bd f NA I dg p g If A 30

31 2011 Ip P d Ip d(hdd) Ip Uxpd fy p SUSAR p (.g. dh.) I d fy Cp Sp b NA g wh f p f Rq f NA w d Tg bh p d g If A 31

32 5. Sgh h Cp f C T STRENGTHEN THE COMPETITIVENESS OF CLINICAL TRIALS g If A 32

33 5 I d k f 2020 C F C Pg Gp Sgh h gy p Ebh g p f d d dp 2020 C F C Pg Gp Sgh h pby f Eh h y f Sgh h fy p y f g If A 33

34 Nw KFA Off Og Hh Ad Tw Ck W Og d Hh M x y Ad Tw Sd Thd Fh» Ffh g If A 34

35 THANK YOU FOR YOUR ATTENTION g If A 35