24.04.27 () 09:42

Dailypharm

X
㰡 ڷ , Ǿǰ ǰ񰻽 '˰'
ȣ 2017-01-24 06:14:57
㰡 ڷ , Ǿǰ ǰ񰻽 '˰'
ȣ 2017-01-24 06:14:57
"2017 ̰͸ '' ˾Ƶμ"



غ CTD() Ȯ ׸ ؿ յǴ 㰡 ڷ ̷ ̴.

2018 1 1 ǰ㰡 Ǵ  Ǿǰ ǰ񰻽 ϴ ȿⰣ 6 6 ûؾ Կ ǰ ȴ.

2014 ǰ ִ ľó GMP 簡 ص 110 GMPҸ ǽõǰ, ߱޵ ̴.

࿡ Ѱ 91% ̸ ǸŰ Ǹ, Ʈ ó 2 Ͽ 3 ¡ ȭȴ.

ѱȸ(ȸ ̰ȣ) '2017 ޶ ֿ ' پ å ȭ ̶ .

ǰ񰻽 2018 =5 Ǿǰ ȿ ؾ߸ 㰡 ǵ ϴ Ǿǰ ǰ㰡(2013 1 1 ) 2018 1 1 ȴ.

̿ ü ش ǰ 㰡(Ǵ Ű) ȿⰣ Ϸκ 6 û ۼ ǰǾǰó ؾ Ѵ.

ǰǾǰó 2013 1 㰡 ǰ Ŀ 㰡 ǰ ñ⸦ ǰ񰻽 ȹ̴.

̿ 2013 1 㰡 Ǿǰ 켱 2018 2023 ǰ񰻽 ޴´. Ǿǰ̸, Ǿǰ Ǿǰ ܵȴ.

CTD Ȯ ڷ ȭ=Ǿǰ ǰ㰡 Ű ɻ ʿ 2016 3 20Ϻ CTD(Common Technical Document, ) Ȯ, ڷ ȭ ̴.

CTD ICH(Ǿǰȭȸ) Ǿǰ νɻڷ ȭ ϱ ȭ ǥع, ڷİ ħ̴.

CTD 㰡û ǰڷüࡤӻ ӻڷ ࡤǰӻ躸ӻ躸 ȴ.

ž࿡ 2016 3 20 ž Ǿǰ ڷǾǰ, ׸Ǿǰ CTD Ǿǰ Ȯƴ.

, Ǿǰ, Ƿа, 缺Ǿǰ, Ǿǰ, ۿ üܿǾǰ ü ʴ ǰ ܵȴ.

׸Ǿǰ ڷ ǹȭƴ. ̿Ͱ 2016 12 24 ߰, Ǿǰ( ֻ ) , , ֻ ڷḦ, 2017 12 24Ϻ ǥǰþþ, ( ֻ ) Ǿǰ , , ȭ , ڷḦ ߰ ؾ Ѵ.

߸Ʈ ó ȭ, 2 3 ¡= 2016 12 2Ϻ Ʈ ó ȭƴ.

Ǿǰ Ǹ ҹ ϴ Ģ 2 ¡ Ǵ 3õ ݡ 3 ¡ Ǵ 3õ ݡ ƴ.

Ѱ 91% ̸ Ǹ = Ģ Ǿǰ 2017 1 1 Ǿǰ Ѱ 91% ̸ Ǹϴ ȴ.

Ǿǰ δϰ Ǹŵʿ Ȱ صǴ ϱ Ǿǰ ̴.

̿ Ǿǰ Ծڴ Ѱ 91% ̸ Ǹ ó(1 : شǰ Ǹž 1, 2 : 3, 3 : 6, 4 : 㰡) ް ȴ. ش 3 ϸ, 2019 12 31ϱ ȿ .

110 GMP ߱= 2014 10 10 Ǿǰ Ģ ǰǾǰó GMP(Ǿǰ ǰ) ߱ ؿ ȴ.

ľó 2015 122 Ǿǰ , 2016 122 ҿ ̾ 2017 110 Ҹ 縦 GMP ߱Ѵٴ ȹ̴.

3 ֱ ŵǴ GMP PIC/S GMP Ǿǰ ǰذ ȭ ȮѴٴ Եƴ.

ȿⰣ ִ ҿ Ǿǰ ǰ㰡 û Ǿǰ ǰ ǽûȲ 򰡿 ڷḦ ִ.

̷ Ǹ ǰ ǰ ʿ Ǿǰ(ž, , ֻ, ̽) ̿ܿ ǰ㰡ܰ迡 GMP򰡰 Ǵ ־.

PIC/S GMP  GMP Ե о 缺Ǿǰ Ƿа ش Ҵ 2017 12 GMP ߱޹޾ƾ Ѵ. GMP ߱޹ ϸ 2018ʹ ش ǰ ǸŰ ȴ.

߾డ ֱ 12 ȯ=2016 10 24 ء ǰŷ ֱ⡯ డ ֱⰡ 1⿡ 2 ȴ.

2017 6 30̸, 2 ֱ Ѵ. Ⱓ 1 , Ⱓ 2016 7 1Ϻ 2017 6 30ϱ ȴ.

Ǿǰ ǥ= 12 3Ϻ Һ ˱Ǹ Ǿǰ Ǵ  ҷ Ѹ ϴ Ī ǥⰡ ǹȭȴ.

̿ Ǿǰ ǰ㰡 ڿ ڴ ǰ㰡 ǰŰ Ī ȿ з(ȿ и ƴ ), з ǥؾ Ѵ. ٸ, ҷ Ѹ ϴ ִ.

Ǿǰ ۿ ر ޹ Ȯ=1 1Ϻ Ǿǰ ۿ ر Ȯȴ.

2014 12 16 Ǿǰ ۿ ر Ģ 3(ر޿ ܰ ޹) Ͻú(2015), Ͻúݡʺ Ͻú(2016) ̾ 2017 1 1Ϻ ޹ Ȯȴ.

߰ ⳻ ۼ=Ǿǰڷ Ͽ ͵ ⺸ ۼ ǹȭ 2017 6 3 ϴ ȸ迬 ȸ迬 Ѵٴ ܼ׿ 2018 ȴ.

ش ο ٰڷḦ 5Ⱓ ϵ ߰, Ǻ ʿϴٰ ϴ ⺸ ϵ 䱸 ֵ ߴ. ⺸ ٰ ڷ 䱸 200 ΰ޴´.
ȣ (leejj@dailypharm.com) ٸ
  • μ
  • īī
  • ̽
  • Ʈ
  • 0
/home/dailypharm/issueData2017/
ǰ
0
͸ǰ | Ǹǰ߾ Ģ
ݱ

Ǹ ͸ , Ǹ ̸ ̵ ˴ϴ. ͸ ʸ ϸ, ͸ մϴ.

ڹ(-ڴϾ-ʱ ) ˵ ϸ ȸ Խ ⡯ ĺ Ʈ ׻ ֻܿ ˴ϴ. ο ø Ϲȸ Խ ĺ ڴϾ ȸ ϴܿ ǽð ˴ϴ.

뺸 ϰ ̵ ̿ Ǵ ֽϴ.

  • ۱ǡΰݱ Ÿ Ǹ ħϴ

    α׷ ϰ , ȳϴ Խù

    Ÿ Ǵ 3 ۱ Ÿ Ǹ ħ Խù

  • ٰ 桤 Ѽϴ Խù

    Ư ̿ ο ν 弳

    Ư 븳 ϴ

    Ȯ ȵ ҹ Ű

    弳 , Ӿ

    Ź, ɿ ˵Ǵ ( û )

    Ư ̳ ü ϴ

    Ư ѼϿ ش ûϴ

    Ư (ֹεϹȣ, ȭ, ּ ) Խϴ

    Ÿ ID Ȥ г ϴ

  • Խ Ư ѵǴ

    ʴ

    翡 ߺ

    κ Ͽ ݺ ϴ 쵵

    Խù,

    Ե Խù

    Խù б

  • û ִ

  • Ÿ

    ʿ伺 ̸

    Ÿ ˵Ǵ 縦

    Ÿ  ڰ ʿϴٰ ǴܵǴ

  • Ȯ

    ۱ڷκ , , ϴ

    Ÿ ʻ ħϰų ϴ

    翡 ̿ (Ÿ ID, йȣ )

  • ̻ Ϻ ׿ ̿ 縦 , Ρ ó ֽϴ.

    õ ̴ ҹ Ǵܵǰų ϸ 񽺿 ٶ ʴٰ ǴܵǴ ġ ϰڽϴ.

    رŸ ϸ ڿ ֽʽÿ. ּҴ dailypharm@dailypharm.comԴϴ.

ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 04)
౹ 31
ǰ ְ
ѽŻ÷(10) 3,500 2,500 1,000 3,009
޾(100) 24,000 23,000 1,000 23,200
Ʒγΰ(100) 30,000 28,000 2,000 28,500
īɾ(10g) 7,000 6,000 1,000 6,559
Ľõ򿬰(5g) 5,000 4,500 500 5,138
Ź(4) 5,000 4,000 1,000 4,438
ڶ(20) 6,000 6,000 0 6,000
(10) 6,000 4,500 1,500 5,071
Ժ(10) 4,000 3,500 500 3,712
ڱ׸(20) 5,000 4,500 500 4,717
ť(10) 3,000 2,500 500 2,990
Ȱť(1) 1,200 900 300 1,182
Ǯɾ(3.3ml) 26,000 23,000 3,000 24,250
޵𿬰(10g) 7,000 5,900 1,100 6,289
öŸ(34) 13,000 11,000 2,000 11,866
뽺ī(20g) 22,000 18,000 4,000 20,184
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 8,500 1,500 9,205
ͺ(10) 3,500 3,000 500 3,196
ݿ(1ڽ) 3,000 3,000 0 3,000
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,524
߽Ÿ(120) 70,000 50,000 20,000 60,385
Źĸ(10ĸ) 3,000 2,000 1,000 2,989
Ÿ̾(120) 60,000 50,000 10,000 51,538
տ(60ĸ) 29,000 25,000 4,000 27,600
Ÿ̷ER(6) 3,000 2,500 500 2,750
ٿ(30g) 12,000 9,000 3,000 11,444
(120) 25,000 22,000 3,000 24,991
Ʒ(6) 4,000 3,000 1,000 3,262
ǽõĸ(270ĸ) 110,000 110,000 0 110,000
B(120) 70,000 70,000 0 70,000
׳(10) 3,000 2,500 500 2,778
6̺(10) 3,000 3,000 0 3,000
(60) 230,000 220,000 10,000 223,333
Ⱦ 12,000 10,000 2,000 10,143
̰źĸ(60ĸ) 35,000 30,000 5,000 33,231
Ųť(20) 5,500 4,500 1,000 4,903
λ絹÷(100) 35,000 32,000 3,000 33,297
ü



ͳݽŹϹȣ: 00048 | 2005.09.09 | 2005.09.09 | : | : ȣ
ּ: ı 128 SK V1 GL ƮνƼ A 401ȣ
ȭ : 02-3473-0833 |ѽ : 02-3474-0169 | ûҳ⺸ȣå(å ű)
Contact dailypharm@dailypharm.com for more information
ϸ () ϴ ۱ǹ ˵Ǹ, 縦 ֽϴ.