□ The Ministry of Food and Drug Safety (Director Kang-rip Kim) explained the future approval process for the COVID-19 vaccine and treatment currently being developed at home and abroad.
○ For reference, the Ministry of Food and Drug Safety is currently undergoing a preliminary review for three vaccines developed by overseas pharmaceutical companies, and domestic antibody treatment companies have announced that they plan to apply for approval for use within this month.
○ The drug approval process begins when a manufacturer or importer applies for an item permission, and the company submits the necessary data for the permission stipulated in Articles 31 and 42 of the ｢Pharmaceutical Affairs Act｣ to the’National Drug Safety Administration’ when applying for permission. You should.
< Drug approval process >
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① Receipt |
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② Preliminary examination |
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③ judge |
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④ advice |
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⑤ permission |
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National shipment approval (vaccine) |
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○ Major submissions include non-clinical, clinical, and quality data.
-Non-clinical data are data that verify safety and effectiveness through animal tests before administering drugs to humans.
-Clinical data are data that test the safety and effectiveness by administering drugs to humans (patients),
-Quality data are data on the manufacturing process management, standards and test methods for quality control of the drug.
○ The Ministry of Food and Drug Safety has formed and operates a team dedicated to approval for COVID-19 vaccines and treatments, and the final approval of the data submitted by the company by combining the review results of experts in each field and the opinions of external experts such as the Central Pharmacy Review Committee if necessary. Do it.
-The Ministry of Food and Drug Safety aims to shorten the existing processing period (180 days or more) and process it within 40 days through the preliminary review of each item and the expedited permit review by the exclusive approval team.
[국가출하승인 절차]
○ Vaccines, which are biological products, can be distributed and sold only after passing the national shipment approval, which checks the quality once more. This is a procedure to ensure the safety and effectiveness of the vaccine once more.
-National shipment approval must be applied by all domestic distribution companies, and the KFDA conducts and approves quality inspections by manufacturing number.
-In the case of the COVID-19 vaccine, we plan to shorten the existing treatment period (usually 2 to 3 months or more), with the goal of processing within 20 days.
[특례 제조·특례 수입 절차]
○ Pharmaceuticals can be manufactured or imported only after obtaining product permission, but Article 85-2 of the Pharmaceutical Affairs Act provides special manufacturing and import procedures.
-The heads of relevant ministries may request special manufacturing or special import from the Minister of Food and Drug Safety to appropriately cope with the pandemic of infectious diseases, and may manufacture or import pharmaceuticals that are not approved for product in Korea if special manufacturing or special import is approved. .
< Special manufacturing·Import procedure >
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① Request for drug introduction (Relations ministries → Food and Drug Administration) |
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② National Essential Medicines Deliberation by the Stable Supply Council * Feasibility, Measures, etc. |
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③ Special manufacturing·income Notice (Food and Drug Administration → Related ministries and manufacturing·importer) |
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④ Produce·importer domesticUse, etc. (Produce·importer → Related ministries) |
[국내‧외 코로나19 백신·치료제 개발현황]
○ In the case of vaccines, a number of companies such as AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson) are conducting phase 3 clinical trials.
-As of December 25, Pfizer vaccine has been approved for emergency use in eight countries* including the United States and the United Kingdom, and conditional approval in the European Union and Switzerland, and Modena vaccine has been approved for emergency use in the United States.
* UK, Bahrain, Canada, Saudi Arabia, USA, Mexico, Kuwait, Singapore
-In Korea, five products are currently undergoing clinical trials, and most of them are undergoing initial clinical trials (Phase 1, Phase 1/2).
○ In the case of treatment, Lily and Regeneron are conducting phase 3 clinical trials for antibody treatments, and we have received approval for emergency use in the United States.
-In addition, clinical trials are in progress to add the efficacy and effect of COVID-19 treatment to existing drugs such as’varicitinib’ (arthritis treatment).
-In Korea, clinical trials for a total of 15 products (13 ingredients), including antibody treatments being developed as a novel corona 19 treatment, are in progress.
attachment
Current status of clinical trials for vaccines and treatments for Corona 19 in Korea (as of December 27, 20)
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attachment |
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Domestic corona19 vaccine·Current status of clinical trials for treatment(‘20.12.27.standard) |
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Serial number |
Requester |
product name |
Clinical trial contents(summary) |
step |
Approval date |
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One |
International Vaccine Research Institute |
INO-4800 |
Electroporation after intradermal vaccination for healthy adults(Electroporation, EP)Corona using19 Vaccine safety, Tolerability and immunogenicity evaluation |
1/2aPrize |
2020-06-02 |
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2 |
SK Bio Science(week) |
NBP2001 |
Healthy bay 19~55Corona for three adults19 Vaccine safety, Tolerability and immunogenicity evaluation |
OnePrize |
2020-11-23 |
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3 |
(week)Celide |
AdCLD-CoV19 |
Corona for healthy adult volunteers19 Vaccine safety, Immunogenicity check |
1/2aPrize |
2020-12-04 |
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4 |
Jinwon Life Science(week) |
GLS-5310 |
Corona inoculated intradermally to healthy adults19 Vaccine safety, Tolerability and immunogenicity evaluation |
1/2aPrize |
2020-12-04 |
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5 |
(week)Genexin |
GX-19N |
Corona for healthy adults19 Vaccine safety, Tolerability and immunityOrigin search |
1/2aPrize |
2020-12-11 |
□ corona19 remedy
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Serial number |
Requester |
product name (Ingredient name) |
Clinical trial contents(summary) |
step |
Approval date |
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One |
Bukwang Pharmaceutical(week) |
Levovir capsule30mg (Clevudine) |
Moderate corona19 Marketing to patients medicine(BHepatitis drugs)Safety·effectiveness evaluation |
2Prize |
2020-04-14 |
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2 |
NG Chem biology |
EC-18 |
corona19 Clinical trial drugs for pneumonia patients(Neutropenia)Safety·Effectiveness evaluation |
2Prize |
2020-05-12 |
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3 |
Shinpoong Pharmaceutical(week) |
Piramax tablet (Pyrraridin, Altesunate) |
Mild or moderate corona19 patient object Commercially available drugs(Antimalarial drugs)Safety·Efficacy and safety comparative evaluation |
2Prize |
2020-05-13 |
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4 |
(week)Chong Kun Dang |
CKD-314 (Napamostat) |
corona19 Marketed for inpatients with pneumonia medicine(Anticoagulant)Safety·Effectiveness evaluation |
2Prize |
2020-06-17 |
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5 |
crystal Genomics(week) |
CG-CAM20 (Camostat) |
corona19 Commercially available drugs for patients(Pancreatitis drugs)of safety·effectiveness evaluation |
2Prize |
2020-07-01 |
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6 |
(week)Daewoong Pharmaceutical |
DW1248tablet (Camostat) |
Mild and moderate corona19 Marketing to patients medicine(Pancreatitis drugs) safety·Effectiveness evaluation |
2/3Prize |
2020-07-06 |
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7 |
(week)Genexin |
GX-I7 |
corona19 Clinical trial drugs for patients(Anticancer drugs)Safety·Explore preliminary effects |
1bPrize |
2020-08-07 |
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8 |
(week)Green cross |
GC5131 |
corona19 Patient target H-Ig(High immunoglobulin)Capacity setting and effectiveness·Safety evaluation |
2Prize |
2020-08-20 |
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9 |
(week)Celltrion |
CT-P59 |
corona19 Mild patient Target safety·of mineWeakness And virology assessment |
OnePrize |
2020-08-25 |
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Mild, Moderate corona19 Safety in combination with standard treatment for patients·Effectiveness evaluation |
2/3Prize |
2020-09-17 |
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corona19 Preventive for patient contact effectiveness, Virology and safety assessment |
3Prize |
2020-10-08 |
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10 |
Lily Korea |
LY3009104 (Varicitinib) |
corona19 Commercially available medicines for patients(Arthritis medication)Therapeutic Confirmation Test of |
3Prize |
2020-09-07 |
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11 |
(week)Daewoong Pharmaceutical |
DWRX2003 (Niclosamide) |
Commercially available drugs for healthy adults(helminthic)of safety·Evaluation of tolerability and pharmacokinetic properties |
OnePrize |
2020-10-08 |
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12 |
MSD Korea |
MK-4482 |
corona19 Clinical trial for adult inpatientsTest drug(Influenza drug)Safety·effectiveness, Pharmacokinetic evaluation |
2/3Prize |
2020-10-29 |
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13 |
New Gen Therapeutics |
New Genna Pharmost Tablet (Napamostat) |
Commercially Available Drugs for Healthy Adult Men(Anticoagulant)Safety·Tolerability and agitationEvaluation |
OnePrize |
2020-11-03 |
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14 |
Dong Wha Pharm(week) |
DW2008S |
Moderate corona19 Clinical trial for patients medicine(Asthma medicine)Safety·Effectiveness comparison evaluation |
2Prize |
2020-11-23 |
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15 |
(week)Immunmed |
hzVSF-v13 |
corona19 Moderate and severe patients Target clinical trial drugs(Influenza drug)of Standard regimen and for each dose hzVSF-v13 Safety when administered in combination·Effectiveness and safety Comparative evaluation with standard therapy group alone |
2Prize |
2020-12-07 |