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WHO ¹ÙÀÌ¿ÀÀǾàÇ°Ç¥ÁØÈ Àü¹®°¡À§¿øȸ(ECBS) °¡À̵å¶óÀÎ °ËÅä
½ÄÇ°ÀǾàÇ°¾ÈÀüó´Â ¼¼°èº¸°Ç±â±¸(WHO) ¹ÙÀÌ¿ÀÀǾàÇ° Ç¥ÁØÈ ºÐ¾ß Çù·Â¼¾Åͷμ ±¹Á¦ °¡À̵å¶óÀÎ Á¦¡¤°³Á¤¿¡ °øµ¿À¸·Î Âü¿©ÇÏ°í ÀÖ´Ù. WHO¿¡¼´Â ¾Æ·¡¿Í °°ÀÌ ±¹Á¦ °¡À̵å¶óÀÎÀÇ Á¦¡¤°³Á¤À» ÁøÇàÁßÀ̸ç, ÀÌ¿¡ ´ëÇÑ ÀÇ°ß Á¶È¸¸¦ °¢°¢ÀÇ ºÙÀÓ ¾ç½ÄÀ¸·Î ÀÛ¼ºÇÏ¿© Çѱ¹¹ÙÀÌ¿ÀÀǾàÇ°Çùȸ(johs8739@kobia.kr, 02-2088-3382)·Î 9¿ù 8ÀÏ(±Ý)±îÁö Á¢¼ö¹Þ°í ÀÖÀ½
1.
Establishing stability of in vitro diagnostic medical devices |
Stability(¾ÈÀü¼º)Àº ü¿Ü Áø´Ü ÀÇ·á±â±â(IVD)ÀÇ ½Ã¾àÀÌ ±× È¿´ÉÀ» Á¤ÇØÁø ½Ã°£ °£°Ý(interval 1, 2) µ¿¾È À¯ÁöÇÏ´Â ´É·ÂÀÌ´Ù. µû¶ó¼ ´ëºÎºÐÀÇ ¾ÈÁ¤¼º ¿¬±¸ ¸ñÀûÀº IVD°¡ ¾ÈÁ¤ÀûÀÎ È¿´ÉÀ» À¯ÁöÇÏ´Â ½Ã°£ °£°Ý°ú ÀúÀå Á¶°ÇÀ» È®¸³ÇÏ°í ÀÔÁõÇÏ´Â µ¥ ÀÖ´Ù.
ÀÌ ¹®¼´Â IVD Á¦Á¶¾÷ü¿¡ ¾ÈÀü¼º ÃøÁ¤À» À§ÇÑ Á¢±Ù ¹æ¹ý °¡À̵å¶óÀÎÀ» Á¦°øÇϱâ À§ÇÑ ¸ñÀûÀ¸·Î ÀÛ¼ºµÇ¾ú´Ù. ¶ÇÇÑ WHO PQ(»çÀüÀû°Ý¼º°Ë»ç) ½ÂÀÎÀ» À§ÇÑ °í·Á»çÇ×(expectations, º»¹® 4 Âü°í)µîÀ» Á¦½ÃÇÏ°í ÀÖ´Ù. |
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°¡À̵å¶óÀÎ Àü¹® ºÙÀÓ 1. ÆÄÀÏ È®ÀÎ |
°ËÅäÀÇ°ß¼ ¾ç½Ä ºÙÀÓ 2. ÆÄÀÏ È®ÀÎ |
2.
Human immunodeficiency virus (HIV) rapid diagnostic tests
for professional use and/or self-testing |
ÀÌ ¹®¼´Â IVD Á¦Á¶¾÷ü¿¡ HIV °ËÃâÀ» À§ÇÑ ½Å¼Ó Áø´Ü Å×½ºÆ®(RDTs)ÀÇ WHO PQ ÀÎÁõÀ» À§ÇÑ ±â¼úÀûÀÎ °¡À̵å¶óÀÎÀ» Á¦°øÇϱâ À§ÇÑ ¸ñÀûÀ¸·Î ÀÛ¼ºµÇ¾ú´Ù. WHO PQ ÀÎÁõÀ» À§ÇÑ ÃÖ¼Ò ¼º´ÉÀÌ ¿ä¾àµÇ¾î ÀÖÀ¸¸ç, ÇØ´ç ¿ä±¸»çÇ×Àº HIV °ËÃâ¿ëÀ¸·Î¸¸ Àǵµ µÈ RDTs¿Í ´ÙÁß Å½Áö ºÐ¼®(¿¹. HIV/syphilis ÀÌÁß Å½Áö RDT)¿¡ µ¿ÀÏÇÏ°Ô Àû¿ëµÈ´Ù.
¡ØÇöÀç ÀÌ ¹®¼¿¡¼´Â HIV-1°ú HIV-2 °¨¿°À» ±¸º°ÇÏ¿© °¨ÁöÇÏ´Â IVD ¹× È®ÀÎ ½ÃÇè¿ë IVD, µ¿¹ÝµÈ Ç°Áú °ü¸® ÀÚ·áÀÇ ¿ä±¸»çÇ×Àº ´Ù·ç°í ÀÖÁö ¾Ê´Ù. |
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°¡À̵å¶óÀÎ Àü¹® ºÙÀÓ 3. ÆÄÀÏ È®ÀÎ |
°ËÅäÀÇ°ß¼ ¾ç½Ä ºÙÀÓ 4. ÆÄÀÏ È®ÀÎ |
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°øÁö |
'17³â 2Â÷ ÷´Ü¹ÙÀÌ¿ÀÀǾàÇ° Çã°¡±³À° ¿öÅ©¼ó ÀÏÁ¤ ¾Ë¸²
- ÀÏ ½Ã: 9¿ù 28(¸ñ)~29(±Ý)
- Àå ¼Ò: ¼¿ï ¿¤Å¸¿ö
- ÁÖ Á¦: ºñÀÓ»ó½ÃÇè °í·Á»çÇ× ¹× °³¹ß»ç·Ê, À§Çؼº°ü¸®°èȹ ÀÛ¼º »ç·Ê
±³À°ÇÁ·Î±×·¥Àº È®Á¤µÇ´Â ´ë·Î °øÀ¯ÇÒ ¿¹Á¤ÀÌ´Ù. (¿ø¹®º¸±â) |
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½ÅûÀÚ |
½ÂÀÎÀÏ |
Á¦Ç°¸í |
ÀÓ»ó |
´Ü°è |
(ÁÖ)¸ÞµðÅ彺 |
20170818 |
°Ç°ÇÑ ¼ºÀÎ ³²¼ºÀ» ´ë»óÀ¸·Î ÇÑ ¸ÞµðÅå½Å?ÁÖ(Clostridium Botulinum Toxin Type A)ÀÇ ¾à·ÂÇаú ¾ÈÀü¼ºÀ» Æò°¡Çϱâ À§ÇÑ ¹«ÀÛÀ§¹èÁ¤, ÀÌÁß´«°¡¸², È°¼º¾à´ëÁ¶, ÆòÇ౺, ´ÜÀϱâ°ü, Á¦1»ó ÀÓ»ó½ÃÇè |
1»ó |
¸ÞµðÅå½ÅÁÖ |
ÄڹݽºÄÚ¸®¾Æ
¼ºñ½ºÀ¯ÇÑȸ»ç |
20170818 |
°íÇü Á¾¾ç ȯÀÚ¿¡¼ ÄÚºñ¸ÞƼ´Õ + ¾ÆÅ×Á¹¸®ÁÖ¸¿ÀÇ À¯È¿¼º°ú ¾ÈÀü¼ºÀ» Á¶»çÇÏ´Â II»ó, °ø°³, ´Ù±â°ü, ´ÙÄÚȣƮ ÀÓ»ó½ÃÇè |
2»ó |
ÄÚºñ¸ÞƼ´Õ(RO5514041),
¾ÆÅ×Á¹¸®ÁÖ¸¿ (MPDL3280A) |
ÄýŸÀÏÁî
Æ®·£½º³»¼Å³Î
ÄÚ¸®¾Æ(ÁÖ) |
20170818 |
ÀÌÀü Ä¡·á °æÇèÀÌ ¾ø°í ÀýÁ¦ ºÒ°¡´ÉÇÑ ±¹¼Ò ÁøÇ༺ ¶Ç´Â ÀüÀ̼º °£³» ¹× °£¿Ü ´ã°ü¾Ï ¹× ´ã³¶¼±¾ÏÀ» °¡Áø È÷¾Ë·ç·Î³ ¼öÁØÀÌ ³ôÀº(HA-high) ½ÃÇè´ë»óÀÚ¿¡¼ ½Ã½ºÇöóƾ+Áª½ÃŸºó°ú ºñ±³ÇÏ¿© ½Ã½ºÇöóƾ+Áª½ÃŸºó°ú º´¿ëÇÑ Æä±×È ÀçÁ¶ÇÕ »ç¶÷ È÷¾Ë·ç·Î´Ï´ÙÁ¦(PEGPH20) ¹× ¾ÆÅ×Á¹¸®ÁÖ¸¿°ú ½Ã½ºÇöóƾ+Áª½ÃŸºó°ú º´¿ëÇÑ PEGPH20¿¡ ´ëÇÑ Á¦lb»ó, ¹«ÀÛÀ§¹èÁ¤, °ø°³ ÀÓ»ó½ÃÇè |
1»ó |
PEGPH20,
¾ÆÅ×Á¹¸®ÁÖ¸¿ |
À̼ö¾ÛÁö½º
ÁÖ½Äȸ»ç |
20170817 |
ÁøÇ༺ °íÇü¾Ï ȯÀÚ ´ë»ó ErbB3¸¦ Ç¥ÀûÀ¸·Î ÇÏ´Â Àΰ£ ´ÜŬ·ÐÇ×üÀÎ ISU104ÀÇ ¾ÈÀü¼º, ³»¾à¼º ¹× ¾àµ¿ÇÐÀû Ư¼ºÀ» Æò°¡Çϱâ À§ÇÑ Á¦ 1»ó, °ø°³, ¿ë·®°áÁ¤ ÀÓ»ó½ÃÇè |
1»ó |
ISU104 |
»ï¼º¼¿ïº´¿ø |
20170816 |
¼ö¼úÀû ÀýÁ¦°¡ ºÒ°¡´ÉÇÑ ½ÄµµÀÇ ÆíÆò»óÇÇ¾Ï È¯ÀÚ¿¡¼ ±ÙÄ¡Àû µ¿½ÃÇ׾Ϲæ»ç¼±Ä¡·á¿Í Durvalumab + Tremelimumab º´ÇÕ¿ä¹ý¿¡ ´ëÇÑ ´ÜÀϱº Á¦ 2»ó Àӻ󿬱¸ |
2»ó |
MEDI4736
Tremelimumab |
¹Ú¼¿¹ÙÀÌ¿À |
20170814 |
Àç¹ß¼º ¶Ç´Â ºÒÀÀ¼º ´Ù¹ß°ñ¼öÁ¾ ȯÀÚ¿¡¼ ¼öÁö»ó¼¼Æ÷¿Í ·¹³¯¸®µµ¸¶À̵å/µ¦»ç¸ÞŸ¼Õ º´ÇÕ¿ä¹ý ¶Ç´Â ·¹³¯¸®µµ¸¶À̵å/µ¦»ç¸ÞŸ¼Õ º´ÇÕ¿ä¹ýÀ» ºñ±³ÇÏ´Â ¹«ÀÛÀ§ ÀÓ»ó 2»ó ¿¬±¸ |
2»ó |
Vax-DC/MM |
¾Ë¹ÙÀÌ¿À |
20170811 |
¡ºÅðÇ༺ ½½°üÀý¿° ȯÀÚ¿¡¼ ¡®Á¶ÀÎÆ®½ºÅÛ¡¯ÀÇ À¯È¿¼º ¹× ¾ÈÀü¼ºÀ» Æò°¡Çϱâ
À§ÇÑ ´Ù±â°ü, ¹«ÀÛÀ§¹èÁ¤, ÀÌÁß´«°¡¸², À§¾à ´ëÁ¶ Á¦2b/3»ó ÀÓ»ó½ÃÇè¡»ÀÇ
Á¦2b»ó ½ÃÇ豺¿¡ ´ëÇÑ °ø°³, ´Ù±â°ü ÃßÀû°üÂû ¿¬±¸ |
¿¬Àå |
Á¶ÀÎÆ®½ºÅÛ |
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FDA |
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Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
LYNPARZA
NDA #208558 |
OLAPARIB |
½Å¿ë·® |
ASTRAZENECA PHARMS |
08/17/2017 |
DRAX EXAMETAZIME
NDA #208870 |
DRAX EXAMETAZIME; |
½ÅÁ¦Çü ¶Ç´Â ½ÅÁ¦Á¶¿ø |
JUBILANT DRAXIMAGE |
08/17/2017 |
BESPONSA
BLA #761040 |
INOTUZUMAB OZOGAMICIN |
- |
WYETH PHARMS INC |
08/17/2017 |
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EMA |
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Name |
Active Substance |
Therapeutic areaCompany |
Date of authorisation/ refusal |
Ritemvia |
rituximab |
Lymphoma, Non-Hodgkin
Microscopic Polyangiitis
Wegener Granulomatosis |
13/07/2017 |
Blitzima |
rituximab |
Leukemia, Lymphocytic,
Chronic,
B-Cell Lymphoma, Non-Hodgkin |
13/07/2017 |
Maviret |
glecaprevir / pibrentasvir |
Hepatitis C, Chronic |
13/07/2017 |
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Clinical.gov ¹Ì±¹ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03255018 |
Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extra-Nodal Diffuse Large B-cell Lymphomas |
-Non-Hodgkin Lymphoma
-Lymphoma
-Diffuse Large B-Cell Lymphoma
-Gray Zone Lymphoma
-Primary Central Nervious System Lymphoma |
Drug: Pembrolizumab |
-National Cancer Institute (NCI)
-National Institutes of Health Clinical Center (CC) |
Phase 2 |
NCT03251924 |
A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors |
-Cancer
-Tumors
-Neoplasm
-Malignancy |
Drug: BMS-986226
Biological: Nivolumab
Biological: Ipilimumab |
Bristol-Myers Squibb |
Phase 1
Phase 2 |
NCT03256136 |
A Phase II Study of Nivolumab in Combination With Carboplatin and Pemetrexed, or Nivolumab in Combination With Ipilimumab, in Patients With Advanced, EGFR-mutant or ALK-rearranged, Non-Small Cell Lung Cancer |
Lung Cancer |
Drug: Carboplatin
Drug: Nivolumab
Drug: pemetrexed
Drug: Ipilimumab |
-Massachusetts General Hospital
-Bristol-Myers Squibb |
Phase 2 |
NCT03254927 |
A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma |
Advanced
Head and Neck Squamous Cell Carcinoma |
Drug: CDX-3379 and cetuximab |
Celldex Therapeutics |
Phase 2 |
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Clinical.gov À¯·´ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
Nation |
NCT03255382 |
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM? in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy |
Psoriasis |
Drug: risankizumab
Drug: Fumaderm |
AbbVie |
Phase 3 |
µ¶ÀÏ |
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