abracro (2011) guarantee of acces to post-clinical trial drugs

8/9/2019 ABRACRO (2011) Guarantee of Acces to Post-clinical Trial Drugs

1/30

Gaa Acc PCca Ta D

ABRACRO Aca Baa Oaa Raa Pa Cca [B A C O]

Sa Pa, 2011


2/30

2ABRACRO Gaa Acc PCca Ta D

Ic ....................................................................................................................................... 3

ABRACRO V Haaa .................................................................................................................... 4

D. F Gb Eac Ec .......................................................................... 7

D. L A Taa R Ec ........................................................................... 10

D. Sa Da Ec .................................................................................................. 13

D. N K O Taa .......................................................................................... 17

Paa G Saa a Maa Pca Sac ................................................ 19

D. Aa Fa C K La .................................................................................................... 22

ANVISA Paca Fa A a Fa Nac Ma Vaa ...................................... 25

I N P [Naa I Pbc Ha] (Mc) D. Ja I

Ca R ................................................................................................................................. 28


3/30


GAANEE OF ACCE O POCLINICAL IAL DG

T ca a a a c

ac a a b a a a

c.

O a cca, ca a a ac c, a a c

CRO, a, , a, ANVISA a CONEP, c

Sa c Sa (SUS) [ H ] ca.

I a a c a c

c, ABRACRO a a bca, c ca aa a, a a ca Ha La, a aca ca Cca

Rac, a a ANVISA, Aca Naca Vca Saa [N

A H ]. Ua CONEP (C Naca ca Pa),

N E C, a c a aca

bca a a a a a.

B bca, Caa Bc C

Naa I Pbc Ha Mc, a c cca a La

Aca .


4/30


INODCION

E acc aa c a ca ca a, ba b ab a ca. O a a

a cc ca.

C, CONEP a aa cca a a

aa a c acc aa c,

Pca Ia cb b a. T a a

a cca a cc Ba, acc , acc a

ca ac, ac ca, c c.

HE ANALI

I cca ac, a a ca acc, 1. F

a ac a, a aa a a c :

cac b a a a a b a ac

a. I baac b aab a ac a a

a a ab a aca ca.

A a cca , a II III, a a a a a

cac c, b a, ab a. D ,a a a a caa a a ca,

a ac a a b a a c.

I ca a aa a, ca c

a a , c ab acc. I

ca, cac a b a a a , a a a

.

I ca, cac ca, a ac a a c . I abc b a baac

b cac a a a a a aa a,

ca c b c a c a a

a.

1 Paaa 8 Dcaa H.


5/30


ACCE O HE CLINICAL IAL E POCLINICAL IAL ACCE

Aa, c ac a aa

aa c ca, b a b.

T b a c a a c

ca b a a bc a a b a ba. A CONEP

c a a b Ia, a a b

a b a, a c bc c ca .

I ca, aca b ca b a a ca a a aa

cca a, a a, bc, acac, aa

aa c.

I a ab ca, b a (acc, acc, c...), a cca a

Ba.

T c c a acc, b acc cca a

c. A cca a a a b ca

aa, a a b aca a

a a. O a ca Rbca Vc

P, a U Sa aca a cca a

a c a b cc Ba.

HE AL CONEPOIN

T Dcaa H, aaa 33, a a ac bc b

a a c a a b . O

Baa a a a .

Fac , I a, a a , 6 a a a bc

a a .

A a b, b b a bac, c

ca aa , a a ca a a

a.

T a c b, c a a a ca a bc,

a a c a.

T a a , b a ac aa a

c, a a a.


6/30


Sa ab a, a bac . T a

ca aa c , a ab a ca a a

a c bc a . T a a

a b a b c bc , c

a cc b ca a c a b.

HE PAIEN FEE ILL

O a a a ac bc cc c

c aca , b a b c a

a aa c a aac c

a' c. S a a a a.

CONCLION

T baac b a aa bc b a acc

b b a ca c a a a

aa a a a aa c a

cca a.

I ca, b ab baac b cac a a ac

bc a a a a

aa a c , a a a

/.

T ca c a a a b , a

a a a a , c b a a

cca a , a aa b Ec C, a ca b ca

ba.

P D ABACO

C O D ICON C B


7/30


.

ACCE O HE POCLINICAL IAL MEDICAION

T acc a a c a cca a a c bc ca, a, aaa, cc, a a ca ca. F a

b a a c aac, aa, ca a

ac ca ccac a ca.

I cca ac, ca c acc a c, a

ccac a ca a a a a

ca c, c a ca. Aa a a bca

/b a, , a b aa a aab,

c a a a ac a . T, a ac

a ba b , a a b

aa a b cb. O cca a ca, ca

c c , / /

, ,

,

.

T a a, bca a a ac b a caa a cca

a, b a a a a ca a cc.

Ta a a a a c a a a a b:

S a a cc a 2 ab a ca abc c

ac a a ca aaa ca a a

a, c a. T a 24 a a

a ca ca b b ba a

. S a a aca a (a a a) a ac,

aaa, aa ca b cc ,

c a c a. T a a b b a .

Ia a c, a c a

, a. A , ac ca ba cac, a a a a

a b cc a c . O a, a

c, a , b a ( a aac),

c a a aaa a ca ca, b a a

cca a c.

F a ca a

.


8/30


T a c Dcaa H, aaa 30, a a a

aca b a acc b ac . W

CNS 251/97 ( ) a

( 3). T a cca a ca

a a a aa b a, a ,

ab a.

I a, a a c a cca a a

c c a ca acc ac c. T a a ca a

a ab aa a a ca b a a

a.

T, a a a ca b ab

a ca b c a a c c

a ca a c ca ba b CONEP.

T b ca , bca a cca a,

b a a ca a cc

acc ab a c, b ca.

I c a c a ca a a a a

c . T, ca ca

b c a a c b a, a ca ca.

H, b, a b, a ca a a

a a a a a b c.

F a , a a a a

aa ca, c b ca, ca b

aa a a c b a a a

c a a b . I ca a acc

b b ANVISA b a a c.

I c ccac, acc a ca a aa

a a c .

I c, c a a a a a a a

a ca. Eca a c , c aca a

a aa b c.

I acc ca , b b a a

bac ca ca.


9/30


T b aa c acc a a a a

c a a a ca b a a a ca a a a

b a b c a a a a a b

.

.

M E P P

C D CPC C P C CPCL C C

APCB D A P C B B C A


10/30


.

POD ACCE: EACHING FO A OLION

T ba ab b a a cca a aaa a a a ca a cc ca.

A a c, , ca c a a a, a

aab a aa , aa a ca.

W c WMA1 (W Mca Oaa) a Dcaa

H, a a aab a a a aa b

a. T a a b a: b a

c a b a a a c a a,

a a c.

I Ba, a " a a c acc ac bc

ca c a" a b c ca aa

c ca c aca. I ca

, a a a a b a a

ac ( ac a aa), a,

b b a a (c a

a c a ca a ac)? F: b b

a aa cc a ?

T c acc a a a c

aa, c a bc, a b, ba ( a

bacac a b ca c aca)

a a a a aa cc c, c b

ca c b c2

HE MH OF FEE PPL

T ba aa a a a aca b

a cca aab . T a ca a a ac ca a a a a . O

a a ac c a ,

, a a a

a a aa, a acc a a a ac

a aca . I a a ac 3, aa

a b ca a, a a a a ca, cc, a ca

a aca b aa a c R

Ja, a cc, c a a a3 (a

a ac bc c).


11/30


Sa, acc aa a a c c,

c bc , b a a a b

Ec R Ba aa HIV/AIDS4. A a a

a c aca a a a ca

b ca, b b IRB/REC (I R

Ba/Rac Ec C) a a a ca a

a a a ca b aa.

EMAIAION

T, ca b c a a aaa a

acc a a a.

A aa c (c b a c a,

ca a a a a c cc ), ac cc a c ba Aca c c Fa R

Ea Acc Iaa D Iaa Ta D a Ca

b b FDA 20095 . I ac a aa a aa

aaa, ba cc c, c a a a

a a, a aca a aca c, c c

c. Saa ca a

ccac a b a, ab ca

acc a a c b c a a. A a

ac, a c a b a c ca c

c a aa a , c:

C a ca ab (..: , a a a c aa);

C a ca a a a ac (c a a);

C a (c a ca a c);

C a c a cca a a ( cac);

I a a c a ac, a

a a a aa a, ab, ca aa

b c;

ACCE FND

I a c ab a, c c ca b ab

ac b a a, a c c 2008/09 c,

ca ca c, a cc a c a, acc

aa c a c ( ).

L c a a 1,6, c aac

, c a T HIV Na Aaa Taa Rac Caba (HIVNAT)

a a a aac a ab,aca c a b (


12/30


a ). T a b a a, a a

b , a, ca b ab, a

a , b a!

CONCLION

T c a ab b a a cca a

b ac b a bc ac aa ca c c

acc b , a a , , a

a. Ob a c a aa ba b a a

: a, ac, a Baa c. T ca a

acc , ac a ca c a bc a

a aca a a a a acc, a a

C.

EFEENCE

1.

Aaac J ET c. Ca a cca a Acc aa..ac.c V 364 J 3. 2004.

2.

T F. Gbaa Cca a. Na V 7 . Ja 2008.

3.

Lacaa P, R LA, c. P S Pa Cca C AbaaI. R. Cca Sa Ca, 13(3)2008.

4.

Pac c. Pa Acc I: T V IRB/REC Ca, Ia, aRac Paca a Maa HIV/AIDS S.

5.

Fa R Ea Acc aa D Ta U a Ca

Iaa Pc. .a./D/D.Fa R V 74 . 155. A 2009.6. Caa a. HIV C Ta 10(1):1324;2009.

. .

APCB D A P C B B C A

D FC C C H

A P P C J

E D IEDEJ

D CCB B C A P CC A C CCB B


13/30


.

GAANEE OF POD ACCE

T baa cca a, a b c a, b c a c a aa , a c a

ac, . I Ba, aa a a, R Ec Ba, CEP

(IB/EB), a aca C Naca ca Pa [N C

E], CONEP, ba aac a

cca a c. A ba a ca c a cca

ac (Dcaa H a CIOMS, a, a Ba, R 196/96 a

251/97), acca c a, ca ca

cc a.

T c ca ca, c a, ba ca b

ca a a a aca ac

cc, a a , aa a c,

ab ab a a , a . Aa, ac

aca a a, c , acc c aca

c c ca ca . T cc ca a

c bca ac aca (a a ) a aca

ab a a , ac, c, a c acc

aca, a ac aa c ac.

I a Ma 2011, a Fac Mc USP ( P),

c a aa. T bc ac a

c a c a a aa c a

caac a c aa cca ac ca, .. ac, b

R Ec Ba (IRB/REB), a a. A a b cc a

, a a a , a aa a, a

c ac, a a c b a a/

accb ca, a a aca aa.

Qa ba a a aa c a a b a, a c F a I C F (ICF), b

Ocb, 2009 a Jaa, 2010, b CEP (IRB/ERB) (a acc b CONEP b

a a), ac ( ac aa, HIV/AIDS a ab ) a

(a aacca ca ac Ba a a Cca Rac

Oaa, CRO). T ac a a a ac

a a a.

T a IRB/ERB a 20.7% (124 599 a a

), 20% ac (58 290) a 45.3% (24 53). F

a b ca a . W c a ca


14/30


ICF, ab ba a a

. Ra a a aca a ac, 96.2% a

a " a" c, ac b ca ca a a

a; a 94.2% ac cb cc (a). H,

a a: , a a

aca cca ac ac b ca ca a a

a, b ac acc a aa a.

W a ab c aa a , a

a c a (60.4%); a ac,

(43.1%) a b aca a 39.7%

a b b ca.

T a IRB/REB a a a a c ,

b a c (35.3%). T a ca b

aca b (50%). T a c a a, c a, b b a ca.

W a b , ac a

c a b aaab bc ,

IRB/ERB b a a a a c a

b . Pa a b b .

D a a (a a, a c

I , cc Ba, a a), ca b

a, b cb c c, aa

a caac aa cca ac ca.

M aa (a aa) cc ac ac ab

ba. T a c a a, c a

c ca a/ a aa a . T c aa

, a cc , aa b a a

/ a aa a. I b a, a ca,

c a a a a b, a, cc. T ca a

"c" a "b" a ca, a aa, b b a

a acc (RDC 26/99). H, a aac, c a

cc a c a a aaab. I a cca, b

b, c a a a

c a ac, b a, acc La 6360/77,

c ca b b a aa b ANVISA, c a a

c a b ca. Ia, a a a III , a a

b a c b a c (a),

aa caacc a c cca a. O a,

a a a a b a a a, b, a

a a. O ca ab b c a

.


15/30


T bc c a a c a c a

a, c a c. Pbab, a , a ac

ac a a, c a cc, a a a

a a caacc, a ac a, . Ia, a c

c b, a ac, a ca c a aa a cca

a, b a a aa c, b .

I aca a c a, aa , b

aa b a a , . T ca ca HIV/AIDS

Ba. T ac a a cb aca. I ca b,

b, a bc a b. F a c,

a a cca a ca b aca aa a

a aa a c a ca ca a .

T b ac a ; a b a ac, a a a ca b ac

a a.

Rac a a b c a

ac, b ba c . Cca ac a

a c a a bc, , a c a . A

' b aa a ab ca ca a ac.

B a, b a (a ) a a a

a c c a a caac ac .

GGEED LIEAE

1.

Aca Mca Baa. AMB. Dcaa H. [c 18 2010]. Aaab a:://.ab..b/W/_JAMB.

2.

C Naca Sa. CNS. R C Naca Sa 196 1996. [c 18 2010]. Aaab a: ://c.a..b/c/Rc/R196.c

3. C Naca Sa. CNS. R 251 07 1997. [c 18 2010].Aaab a: ://c.a..b/c/_97.

4.

Cc Iaa Oaa Mca Scc (CIOMS), caba W

Ha Oaa (WHO). Iaa Eca G Bca Rac I HaSbc. CIOMS, Ga 2002. [c 25 A 2010]. Aaab a:://.c.c/bca/a_2002..

5.

Da SM. Fc ca a. [] S Pa: Faca Mca,Ua S Pa; 2011.

6.

G JR. O a aa a aca: a, ca ac a. R Paa Sa Pb. 2008; 23(3): 198206. A aaab a:://.c./c.?=S102049892008000300007&c=c_a

7.

Ga C. T ca a c a acc bca a. Ya J HaPc La a Ec. 2005; 1:42535.

8.

Ha EP, La GH, Pc J. Aaab a a c

a cca a U Sa. J C Oc 2010; 28(34): 506773.


16/30


9. Ma MS, Ra DD, La LD. Maa cca a c a a b c: a? E J Cac. 2006; 42: 26757.

10.

ScJ, BR. Ac a a a cca. Ra Bca. 2007; 15(2): 24866.

11.

Sc D. Oba a. RECIIS R E C I I Sa. 2008; 2(S1):S6677.

12.

Sa S. Pa ba aa ac. Pa a Da Bc,NIH Cca C, Oc 27 2010 a a Ha Sbc Rac C. [C 27 Dc10]. Aaab a: ://.bc../c/

.

M D B I

D P M F M P M

P

M BMF B 2003; E BMF (20042005)C NAP (N A P C C G)

HCFMP 2005 2007, N P C (MC/M/FINEP)

N C N, HCFMP,


17/30


.

ACCE O POD MEDICAION

Acc R N. 251/97 Naa Ha Cc (CNS), a ab aa ca a aa acc ca

b . H, a ca b c cc Ba

c . T, ca c a b

, a c b ac aa a a

, Ca Rac Cca Ta (CEPEC) a Naa Ha

Sac Ac (ANVISA ) b cc Naa Cc Ec (CONEP)

a a, c a acc b ac

bc, Ca Pa Ea Cc (CEPEC) [C

C ] a Aca Naca Vca Saa (ANVISA) [N A H

], cca a C Naca ca Pa (CONEP)

[N C E ] a a, c a

a acc b ac bc.

T a a b c a c. Acc a a a

ca aa a c a a

bc a a b a a .

I a c c c b , a c a

a c ca, c b , R a . T, a , a c a,

c . B bc a b caa

c a a b.

T acc aa a a aca

. Ta , a , a c, c a bc a,

c a aca cca ac, a , b

. T, Cc Iaa Oaa Mca Scc (CIOMS)

2002 acc a, a a ca

a a a c.

T b a a ANVISA c. E

b c, a a b.

Sc a , a a

cc a . T ac a, ba a , b a

a, aca a b a b a

a a b a. D , ca, ca c a a

c.


18/30


W cc a R a b ac bc, bca

ca b a, a bc c a, a a

a c. H, c a cca a ,

a a a cc a a.

EFEENCE

1.

.acb.c.b/a//52.

2. .aa..b/ca/a/aca_ca.

3.

.c.a..b/a_ca/2009/24_a_c.

.

A P, D, F C M C P

M C P

C E B C P

C H G C P

A P, D, F M ABC


19/30


GAANEE OF POCLINICAL IAL ACCE AIIC POIN OF IE

W cc a cca a, a b a a

a . T, . A a ca b a a b, a

c a a ba c b a, c c

ab a caacc ca b a. A a b a. Ta a

a a a ca ca a a . T aca

c a, a a a, cc ba

a a. T cc a a , c

aab a a, a c ab aa a

a . A a a a a a b ba a

ca a a.

T ca ca ca a acca aa ac c a

a b a ca cc a a c b a aa

ac c.

A a a ab caca, c a c a

ca a ca c ba aa. F a, a a

a aba , ab. T caca aa b, b

c b a a aaab aa cc a

b ab.

I ab b c, c ab a ?

Saca a, a aca aa a,

a aca c c a c. I

aca ca , a cc a a : I a cac

aca ? I a 71 ac a aca

ca, Fa a. (1974) cc a a ac cac, a

ab c c. T ab a c a

a. A a cc ac a ca ac c a b

aa . M a (1994) cc a "a ab aca

a a b ". I ac, aa cc a a

a a a a a a a . A a,

caca a a c c a ca a a a

ac' a aca.

T a a a cca a ac c a ca b

a a ca caca, b a a a c c accac

a cc . T a a ab,bc, a b a a b a a c


20/30


a c a c. I ca caca a

a a ca ba a ab

cc ac, a a ca a ca b.

I a a ac caca a ,

c b a, a ca ca cb a .

T cc a a caca ca ca.

T a a caca a a ca b acc

aab , a , c

ac .

I a a, a aa c. Aba a a,

a ca c c a c a a cca a

b aca ca a, , a ca a c (,

c, ). E a a, b ba a b a

a c . O a, a a b

a a c a a a a a c c.

T ba a a a ca ; , ba

a a a b a a aca "a".

T ac a a a ac a c

a a a a cac, a. W cc a aa a

a, c ca (a ) ac, b a a

a c, a cc c b a a b a. T a b c a ba a aca aa a a.

T a a a a caca c a ab

a ab a cca .

Ra ca , ac a cca b

ba ba a a ac c a aca a a

aa a ab. T ba a a

a caca, aca aa, a b ab c ca

cac.


21/30


EFEENCE

1.

Fa JA, Ca TC, S H, Kb RR. T ac ba, II , a a a a a c a: 71 a a. N E JM. 1978;299(13):6904.

2.

M D, C DJ, Ea S, O I, R D, a. (1994) I a

aaa a c a: T QUOROM a. Lac 354: 18961900.

CEO PG M

PG P

G P E F P

P H .

PG


22/30


.

GAANEE OF POD ACCE

LEGAL APEC

Cca ac "a ac a b c aacac, aacca, cca a/ c c a/ a ac ac c aca a a/ cac.(EMEA, 2007)1. Cca ac ca a c, a c, a aa a c b a a.

T ca c cca ac a b a ab

Dcaa H. A c a a acc

ac b bc a cc .

I Ba, ca ba Dcaa H a c

C Naca Sa [N H C ] (CNS) a a

ca aa cca ac. U CNS R N. 196/96, ac

a b b ac c,

ca , acc c, c ac a. I c b

CNS R N. 251/97, ab a , ca c,

, ac, , acc ca,

ca a .

T CNS R, , "acc aa ", .., b a ca ba a a ac acc, b , b a a , c..

T C Naca ca Pa Cca [N C E C

] (CONEP) b a a a b a aa ,

c aa b ca ac a a c,

ca a, a c

ab a a aca b b b

a.

T, CONEP, "acc aa " a a ca

a a. T acc

aa ac bc, CONEP , a a c ca aa

cca c, a , a a a c

a c aa a , a

c, a a aa .

1 Ea Mc Ac. ://.aa..b/ca/a/.


23/30


Ya a a b cc ac a a, ,

ac a cac, b a. T,

a , a c , c cca a c

b ca c a aaab.

F a , a a a b a

a a, Aca Naca Vca Saa [N A H

] (ANVISA).

La N. 6.360/76, c a a, ac 12 a ca

b b c a a M Ha. T ,

c a ca a a

a a a a b aa b M

Ha. A a , c b , a

cca, a b M Ha.

I , RDC R N. 26/99 ANVISA a acc a

a a a a c c, c

Ba c , abc aac

ac (a acc a). U La N. 6.360/76, c a a

a a.

T, La N. 6.360/76 a ANVISA RDC R N. 26/99, a

a Ba, ca b acc: () aa b

ANVISA a a a () a a a ca a , a () abc aac ac

aa.

T a ca a ab a a

aa ac, a La N. 6437/77 (Saa Iac La), a a a

c aa a, c, acc ac 273 Pa C, a b La

N. 9.677/98.

A b ca a

c ab, c b Baa a . Acc c

a, a c II Ac 5 Fa C, "

". T CNS R a ca aa

a a .

I c a CONEP c a cc b aa

caa aa acc, c a a caca

c, ca aa ac c. I a, c

c a c, b a,

c a.


24/30


CONEP, b c , a b a a,

a a c, c a , ab a a

a, c a a b c a ac a, ,

a caab a, a a bc a cb ba b a.

D a ca aa c a cc cca

ac Ba, La Pc N. 2.473/03 b D Cb Ma, PPS/BA, c a

a R CNS N. 196/96 c, c, a

D Cab. I c , D Ca D, a

CEP/CONEP b a.

T a ca c "acc aa "

a c a, La N. 6.360/76 b a, a ,

c a a La Pc N. 2473/2003, b ac ab a a

ba, a a aa a cca acc.

.

L, P N A

B L F D P

L P

M (LL.M.) C L , G H L F

P, P P H P

P P I E MBA P

I, FG/INDFAMA B P

P H L I D (IDIA) I H L


25/30


POIN OF IE OF HE NAIONAL AGENC FO HEALH EILLANCE EGADING HE IE:

GAANEE OF ACCE O POCLINICAL IAL MEDICAION.

I Ba, c, a a ca ca b a a a

a a b M Ha1. T ba , a a a

aa ac a a a c (c a

c), c cac a a ( ca ) a caab ( ca

c a a )2.

H, a a c , a cca

a, a acc a a caa a a. I c

ca, c b c a/ ca, ca

acc a a a a aa a

c.

T a a 1980 a c Ac I Dcc

S AIDS. G a a a b a a ab

a b a aca bca

c ca a/ c ca bca a acc

bca a ac . T ca a

a a b a b aca a b

3,4

.

Scca a c ca b ac aca a

c cca a, Dcaa H a aa aa

a ac c cb ca acc ac

bc a b . R N. 251/97 C

Naca Sa [N H C ] (CNS), a a a

acc aa a a b . CIOMS (Cc

Iaa Eca G) a a a c b aab aaab

c aba c a a c.

R N. 196 CNS c b c a ac " b ba ac a c c

a b ", b " ac bc b

c, ca , acc c, c ac a.

I a ca, aa , c b ANVISA a

ca ac a bc c,

a ca bc a a c. H, a a

b c cc Ba a .

I aa , a a a, a,

acc a, b a aa c, a


26/30


ac, a a c a c cca a.

I a , a a a a cac

a aca , a a b ac

ba a a . T a b b a a

aca aa ac aa a cca aa a

a5,6.

A a a aa, bca a c

b a b ca b aa aa a

a. I a, c a a a

a a a c4.

S a b ac a c a ac bc

a aca , b a a a a b c, c

a a aca , ac a ac, aa a aaab, bc a a, a 5. H,

a a ca a bc a cca b a

c c, a c, ca a a b a b

a, a b a a b c. I ca,

b cc , bca

c a a a a ca,

ac bc b a a7.

T, ca a a b aa ; c

aa ca b b ac aa a; a cc a a c , ANVISA, cc a

CONEP, c a c a . T ca a

c a ca a .

T Ac' a a a a cc a b

aa a b , acc ca c. I

ca a a c, ca c b

c a a. I ab a

a a. M, ANVISA cc a acc, b a

ab . T, b c a

a a a Aa. I a a b

aca c c ca cca

a a.

T b ca a a a ' c, ac a

b a, b ca , a a

a a; ca acc aac

c; ab ccc a ;

ca ca a a a a


27/30


b c ca, a , cca a

aa c .

S, c b c aa a c

ab a, a, b c. I a a, c

c c c (c ) a ( a a

) b 8. T a, ab a aa a b

aa a. T a c a

CNS R N. 196/96 a ac a aa a

ac bc ba b c, ca ,

acc aa a, a.

EFEENCE

1.

BRASIL. L 6360, 23 b 1976. D b a ca aa a ca

ca, a a, aacc ca, cc, aa , a ca. D Oca [a] Rbca Faa Ba, Baa, DF, 24 .1976.

2. BUSS, P. M.; CARVALHEIRO, J. R.; CASAS, C. P. R. Mca Ba: a & ac. R Ja: Ea FC, 2008, . 92, ISBN: 9788575411650.

3.

GROOPMAN, J. T a a: S a a acc a ? T NY, N Y, 18 c. 2006. Aaab a:. Acc : 16 a 2010.

4. GOLDIM, J. R. O a aa a aca: a, ca ac a. Ra Paacaa Sa Pbca, Wa, .23, .3, .198206, a. 2008.

5.

DAINESI, S. M. C aa bc a ac a a aca a cca?Ra a Aca Mca Baa, S Pa, . 52, .1, . 56, a./b. 2006.

6. DAINESI, S. M. C a a a a a ca ca P c a c ca aa c a a a ac a cca? Ra a Aca McaBaa, S Pa, . 55, .3, . 237238, 2009.

7.

JNIOR, B. R. S. Ac a a a cca. Ra Bca, Baa, C Fa Mca, . 15, . 2, . 248266, 2007.

8. CASTILHO, E. A.; KALIL J. ca a ca: c, aa. Ra aSca Baa Mca Tca, S Pa, . 38, . 4, . 344347, ./a. 2005.

.

C P E C M N C N

M COPEM

ANIA A N N A H

.

H COPEM

ANIA A N N A H


28/30


() .

ENING HE IGH O ACCE O MEDICINE AFE HE END OF CLINICAL IAL IN MEICO

Mc, a La Aca c, c a a a

aacca a cca a b a a a aba

. T bca c a a , a

cc c a cc a a ca a ac a a

a. I a, Mc a a ab a ac a a

a a a a cc ac cca ac

. Ca V Mca Ga Ha La a ba cc

cca a, c a c Dcaa H a

aa aa.

Cac a aa : 1) Fa C

Saa R Pc (COFEPRIS) c c a, c a a

a aa a 2) Naa Bc C (CNB) c

aa bc a a a a , c ac c c,

a b cca a. Acc c a, aa

cca a b a b b , COFEPRIS a a ac c c.

Acc CcaTa. aaba, Mc 1370 cca a b

aacca a a 70% a a cc bc a

a ac ; , Mc a bca accb aa ba cca

a ca b ca, aca a a T Dcaa H

(aaa 30) a a "a a, a bc aca a ac

b a b acc, ac a ac

a b ". I ca Mca Ga Ha La a

a a Ha Rac Ha Sbc ac a a

ac Dcaa H. T a a / a

a a a c aca c ,

a b c c a COFEPRIS cac

ca.

COFEPRIS c cac ca a ac

aa a cca a a c c aa a

c a bc c ( acb a

aa), c a a. T a a ca b aca

c a a a cc a a a c a cac, ab, a

a a AIDS, a .


29/30


T ca ab ca Mc a ca b

acc ca a cca a.

.

P.D, M , G

M B, CIEB C C

M , INP

P B C INP N, 2008

N L I, CONAC

M B C E M

P B , INP


30/30

abracro (2011) guarantee of acces to post-clinical trial drugs

Documents