The MFDS announces it will shorten the lot release period

Upon submission of non-clinical, clinical, and quality data, final approval after consultation

Domestic antibody therapy, scheduled to apply for approval during this month

The MFDS announced on the 27th that a preliminary review is currently underway for three items of COVID-19 vaccines developed by overseas pharmaceutical companies, and that a domestic antibody treatment development company is planning to apply for use approval within this month.

 

The MFDS said that it would approve the COVID-19 vaccine with a target within 40 days after application for approval and within 20 days of national lot release.

 

According to The MFDS, the drug approval process begins when a manufacturer or importer applies for product approval, and the company submits the data stipulated in Articles 31 and 42 of the Pharmaceutical Affairs Act to the MFDS' Integrated Drug Information System.

 

The main data to be submitted are non-clinical, clinical and quality data.

 

Non-clinical data is to verify the safety and effectiveness through animal testing before administering a drug to humans, and clinical data can be viewed as data that test the safety and effectiveness of administering drugs to humans (patients).

 

Quality data relates to the manufacturing process control, standards and test methods for quality control of the drug.

 

The MFDS operates a dedicated COVID-19 vaccine/treatment approval review team, and final approval is given by combining the review results of experts in each field and the opinions of external experts such as the Central Pharmaceutical Affairs Review Committee if necessary.

 

The MFDS aims to shorten the existing processing period (180 days or more) through rapid approval review and process it within 40 days.

 

In addition, vaccines, which are biological products, can be distributed and sold only after the national lot release, where the country checks the quality once more.

 

This is a procedure to go through the safety and effectiveness of the vaccine once more.

 

National lot release must be applied by all domestic distributors and approved by the MFDS by conducting a quality inspection for each serial number.

 

In the case of the COVID-19 vaccine, it plan to shorten the existing treatment period (usually 2 to 3 months or more) to treat it within 20 days.

 

Pharmaceuticals can be manufactured or imported only after obtaining item approval, but Article 85-2 of the Pharmaceutical Affairs Law provides for special manufacturing and import procedures.

 

The heads of relevant ministries may request special manufacturing or special import from the head of the Ministry of Food and Drug Safety in order to adequately cope with the pandemic of infectious diseases, and may manufacture or import pharmaceuticals that have not been approved for special manufacturing or import.

 

.Meanwhile, the MFDS reported that a number of companies such as AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson) are conducting phase III clinical trials for COVID-19 vaccine

 

.As of the 25th, Pfizer's vaccine has been approved for emergency use in eight countries (UK, Bahrain, Canada, Saudi Arabia, the United States, Mexico, Kuwait and Singapore) including the United States and the United Kingdom, and conditionally licensed in the European Union and Switzerland

 

.And the Moderna vaccine was approved for emergency use in the United States

 

.In Korea, five products are currently undergoing clinical trials, and most of them are undergoing initial clinical trials (Phase I or Phase I/II)

 

.As for the treatment, Lilly and Regeneron are conducting phase III clinical trials for antibody treatments, and they have been approved for emergency use in the United States

 

.In addition, a clinical trial is in progress to add the efficacy and effect of COVID-19 treatment to existing drugs such as Baricitinib (arthritis treatment)

 

.In Korea, it is said that a total of 15 products (13 components), including antibody treatments being developed as COVID-19 treatment, are undergoing clinical trials.