By meeting all World Health Organization (WHO) requirements, the Republic of Korea has become a global leader in drug and vaccine regulation.

The Ministry of Food and Drug Safety in the Republic of Korea has reached the highest level of maturity (ML4) in the World Health Organization's (WHO) categorization of regulatory authorities for medical products. Only one of the 33 nations whose regulatory agencies for medical products have ...

COVID-19 SELF-TEST KITS GIVEN CONDITIONAL APPROVAL IN S. KOREA

Highlights –

• COVID-19 self-test kits given conditional approval in S. Korea.
• The test kits are developed by two biotech firms, SD Biosensor and Humasis.
• The tool however has a low accuracy rate compared to PCR tests.
• The te...

S. KOREAN EXPERTS TELL PFIZER VACCINES SHOWED A 95% EFFICACY RATE

Highlights –

• S. Korean experts tell Pfizer vaccines showed a 95% efficacy rate.
• The expert panel is the first step of three separate independent evaluations.
• The panel is said to have reviewed Pfizer's clinical trials conducted in...

SEOUL DISCTRICT COURT ACQUITTED KOLON LIFE EXECUTIVES ON FRIDAY

Highlights –

• Seoul District Court acquitted Kolon Life executives on Friday.
• The two executives allegedly made fraudulent reports in its gene therapy drug.
• A senior director at the clinical development team is made to pay a fine of 5 ...

S. KOREA APPROVES CELLTRION INC.’S COVID-19 ANTIBODY TREATMENT WITH CONDITIONS

Highlights –

• S. Korea approves Celltrion Inc.’s COVID-19 antibody treatment with conditions.
• The country’s drug safety agency has given conditional marketing authorization of CT-P59.
• Celltrion plans to conduct a global pha...

S. KOREAN GOVT. TO HAVE COVID-19 VACCINATIONS TO 70% OF ITS POPULATION BY SEPT.

Highlights –

• S. Korean govt. to have COVID-19 vaccinations to 70% of its population by Sept.
• The country is said to start its first vaccination next month.
• High-risk health care workers at hospitals, sanatoriums, and elderly care faci...

SOUTH KOREA’S OWN COVID-19 VACCINE TO BE DEVELOPED LATE NEXT YEAR

Highlights –

• South Korea’s own COVID-19 vaccine to be developed late next year.
• South Korean Prime Minister announced the same on Thursday.
• Whereas foreign vaccines are scheduled to be administered starting early next year.
...

COVID-19 VACCINE TO BE APPROVED IN A SHORT PERIOD BY S. KOREAN GOVT.

Highlights –

• COVID-19 vaccine to be approved in a short period by S. Korean Govt.
• Around 180 days is required for a vaccine to be approved on a standard licensing procedure.
• The Ministry of Food and Drug Safety is planning to shorten ...

SOUTH KOREA LIKELY TO SIGN COVID-19 VACCINE DEAL WITH J&J JANSSEN, PFIZER

Highlights –

• South Korea likely to sign a COVID-19 vaccine deal with J&J Janssen and Pfizer.
• The South Korean health ministry said to have procured vaccine deals from four pharmaceutical companies.
• The government has set aside 1.3...