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PIC/S(ÀǾàÇ°»óÈ£½Ç»çÇù·Â±â±¸, Pharmaceutical Inspection Co-operation Scheme)¶õ ÀǾàÇ° Á¦Á¶¿Í Ç°Áú°ü¸®±âÁØ(GMP)ÀÇ ±¹Á¦Á¶È¿Í ½Ç»çÀÇ ÁúÀû ½Ã½ºÅÛ Çâ»óÀ» À§ÇØ 1995³â °á¼ºµÈ ±¹Á¦±â±¸´Ù.
ÇöÀç ÀÌ ±â±¸¿¡ 37°³±¹ 40°³ ±ÔÁ¦±â°üÀÌ °¡ÀÔÇÑ »óÅ´Ù.
PIC/S ȸ¿ø±¹µéÀº »óÈ£ GMP Á¤º¸¸¦ °øÀ¯ÇÏ°í ±¹Á¦ GMP±âÁØÀ» ÀÏ¿øȽÃÄÑ ´Ù¸¥ °¡ÀÔ±¹³» Á¦¾à¾÷üµé¿¡ ´ëÇÑ ½Ç»ç¸¦ »óÈ£ ÀÎÁõÇØÁØ´Ù.
ÀÌ¿¡ µû¶ó ¿ì¸®³ª¶ó°¡ PIC/S¿¡ °¡ÀÔÇÏ°Ô µÇ¸é ±¹³» Á¦¾à»çµéÀº ÇؿܼöÃâ»ó´ë±¹À¸·ÎºÎÅÍ ½Ç»ç¸¦ ¹Þ´Â ºóµµ°¡ ÁÙ°Ô µÅ ÀÌ¿¡ µû¸¥ ºñ¿ë Àý°¨½Ãų ¼ö ÀÖÀ» »Ó¾Æ´Ï¶ó ¼öÃâ ÃËÁø µîÀÇ ÇýÅÃÀ» ¹ÞÀº ¼ö ÀÖ´Ù.
PIC/S °¡ÀÔ ¼Ò¿ä±â°£Àº Åë»óÀûÀ¸·Î ½ÅûºÎÅÍ ½ÂÀαîÁö 3~4³âÁ¤µµ´Ù
Áö³ 1¿ù °¡ÀÔ ½ÂÀÎµÈ ¹Ì±¹ FDAÀÇ °æ¿ì 5³âÀÌ ¼Ò¿äµÆÀ¸¸ç ÀϺ»Àº °¡ÀÔ½Åû Áغñ Áß¿¡ ÀÖ´Ù.
¿ì¸®³ª¶óµµ PIC/S °¡ÀÔ½ÅûÀ» À§ÇØ ¹ë¸®µ¥À̼ÇÀ» ´Ü°èÀûÀ¸·Î µµÀÔ ÇÏ´Â µî ±¹Á¦±âÁØ¿¡ ºÎÇÕÇÏ´Â GMP Á¦µµ¿Í °¡À̵å¶óÀÎ ¸¶·Ã µî Áغñ ÁßÀÌ´Ù.
¶Ç °¡ÀÔ Çʿ伺¿¡ ´ëÇÑ Á¦¾à¾÷°èÀÇ ÀÌÇØ¿Í Áö¿øÀ» À§ÇØ ±¹³» Á¦¾à¾÷°è °ü°èÀÚ¸¦ ´ë»óÀ¸·Î 9ÀÏ~10ÀÏ ÃæºÏ ¿À¼Û ¼ÒÀç ½Ä¾àû¿¡¼ PIC/S Àü ÀÇÀåÀÎ ·Î¹öÆ® Æ®¶óÀ̺ê(Robert W Tribe)¸¦ ÃÊû, ‘ÀǾàÇ° GMP ¼±Áøȸ¦ À§ÇÑ ±¹Á¦ ¿öÅ©¼ó’À» °³ÃÖÇÑ´Ù.
À̳¯ ¡ãPIC/S °¡ÀÔÀÇ ÀÇÀÇ¿Í È¿°ú ¡ãPIC/S °¡ÀÔÀ» À§ÇÑ ±¸Ã¼ÀûÀÎ ÃßÁøÀü·« µîÀ» ½Éµµ ÀÖ°Ô ´Ù·ê ¿¹Á¤ÀÌ´Ù.
½Ä¾àûÀº À̹ø ¿öÅ©¼óÀ» ÅëÇØ PIC/S °¡ÀÔÀ» À§ÇÑ ¼¼ºÎ ÃßÁø°èȹ°ú ºÐ¾ßº° ÁßÀå±â ¼¼ºÎ¾×¼Ç Ç÷£À» ¸¶·ÃÇÏ°í ÀÖÀ¸¸ç ÄÚÆ®¶ó(KOTRA)¿Í ÀǾàÇ°, ÀÇ·á±â±â, ÈÀåÇ° »ê¾÷ÀÇ ÇØ¿Ü ÁøÃâ È°¼ºÈ Áö¿øÀ» À§ÇÑ ¾÷¹«Çù¾àÀ» ü°áÇѹ٠ÀÖ´Ù.
PIC/S °¡ÀÔ±¹ ÇöȲ (2011³â2¿ù ÇöÀç)
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±¹ °¡
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±â°ü¸í
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1
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¾Æ¸£ÇîƼ³ª |
Argentinian National Institute of Drugs |
2
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¿À½ºÆ®·¹Àϸ®¾Æ |
Australian Therapeutic Goods Administration |
3
|
¿À½ºÆ®¸®¾Æ |
Austrian Agency for Health and Food Safety |
4
|
º§±â¿¡ |
Belgian Federal Agency for Medicines and Health Products |
5
|
ij³ª´Ù |
Canadian Health Products and Food Branch Inspectorate |
6
|
Å°ÇÁ·Î½º |
Cypriot Pharmaceutical Services |
7
|
üÄÚ |
Czech State Institute for Drug Control |
8
|
üÄÚ |
Czech Institute for State Control of Veterinary Biologicals and Medicines |
9
|
µ§¸¶Å© |
Danish Medicines Agency |
10
|
¿¡½ºÅä´Ï¾Æ |
Estonian State Agency of Medicines |
11
|
Çɶõµå |
Finnish Medicines Agency |
12
|
ÇÁ¶û½º |
French Agency for the Safety of Health Products |
13
|
ÇÁ¶û½º |
French Agency for Food, Environmental & Occupational Health Safety |
14
|
µ¶ÀÏ |
German Federal Ministry of Health |
15
|
µ¶ÀÏ |
German Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices |
16
|
±×¸®½º |
Greek National Organisation for Medicines |
17
|
Çë°¡¸® |
Hungarian National Institute of Pharmacy |
18
|
¾ÆÀ̽½¶õµå |
Icelandic Medicines Agency |
19
|
¾ÆÀÏ·£µå |
Irish Medicines Board |
20
|
À̽º¶ó¿¤ |
Israeli Institute for Standardization and Control of Pharmaceuticals |
21
|
ÀÌÅ»¸®¾Æ |
Italian Medicines Agency |
22
|
¶óÆ®ºñ¾Æ |
Latvian State Agency of Medicine |
23
|
¸®È÷ÅÙ½´Å¸ÀÎ |
Liechtenstein's Office of Healthcare |
24
|
¸®Åõ¾Æ´Ï¾Æ |
Lithuanian State Medicines Control Agency |
25
|
¸»·¹ÀÌ½Ã¾Æ |
Malaysian National Pharmaceuticals Control Bureau |
26
|
¸ôŸ |
Maltese Medicines Authority |
27
|
³×´ú¶õµå |
Netherlands' Inspectorate of Health Care |
28
|
³ë¸£¿þÀÌ |
Norwegian Medicines Agency |
29
|
Æú¶õµå |
Polish Main Pharmaceutical Inspectorate |
30
|
Æ÷¸£Åõ°¥ |
Portuguese National Institute of Pharmacy and Drugs |
31
|
·ç¸¶´Ï¾Æ |
Romanian National Agency for Medicines and Medical Devices |
32
|
½Ì°¡Æ÷¸£ |
Singapore's Health Sciences Authority |
33
|
½½·Î¹ÙÅ°¾Æ |
Slovak State Institute for Drug Control |
34
|
³²¾Æ°ø |
South African Medicines Control Council |
35
|
½ºÆäÀÎ |
Spanish Agency of Drugs and Health Products |
36
|
½º¿þµ§ |
Swedish Medical Products Agency |
37
|
½ºÀ§½º |
Swiss Agency for Therapeutic Products |
38
|
¿ìÅ©¶óÀ̳ª
|
Ukrainian State Inspectorate for Quality Control of Medicines |
39
|
¿µ±¹ |
United Kingdom's Medicines and Healthcare Products Regulatory Agency |
40
|
¹Ì±¹ |
U.S. Food and Drug Administration |