COVID-19 Vaccine and Treatment Approval Review Period Reduced from 180 Days to 40 Days

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety (MFDS) has decided to reduce the approval review period for COVID-19 vaccines and therapeutics from 180 days to within 40 days.

On the 27th, the MFDS announced this while explaining the approval process for COVID-19 vaccines and therapeutics currently under development domestically and internationally.

Preliminary reviews by the MFDS are currently underway for vaccines from overseas pharmaceutical companies AstraZeneca, Janssen (Johnson & Johnson), and Pfizer. The domestic antibody therapeutic developer Celltrion has announced plans to apply for usage approval within this month.

The drug approval process begins when a manufacturer or importer submits an application for product approval. At the time of application, the company must submit data on non-clinical, clinical, and quality aspects required for approval as stipulated in Articles 31 and 42 of the Pharmaceutical Affairs Act to the MFDS's 'Drug Safety Korea' system.

The MFDS aims to shorten the existing processing period of 180 days to within 40 days through pre-review by product and rapid review by a dedicated approval team.

Biological products such as vaccines must undergo national lot release approval, where the government verifies quality once more before distribution and sale. For COVID-19 vaccines, the MFDS plans to shorten the usual national lot release approval period of 2 to 3 months or more to within 20 days.

Drugs must obtain product approval before manufacturing or import, but Article 85-2 of the Pharmaceutical Affairs Act stipulates a special approval procedure. Heads of related ministries such as the Korea Disease Control and Prevention Agency can request the MFDS Commissioner for special manufacturing or import approval to respond to infectious diseases. Upon approval, drugs without domestic product approval can be manufactured or imported.

Vaccines are undergoing Phase 3 clinical trials by many companies worldwide. As of the 25th of this month, Pfizer's vaccine has received emergency use authorization in eight countries including the United States and the United Kingdom, and conditional approval in the European Union and Switzerland. Moderna's vaccine has received emergency use authorization in the United States.

Domestically, five products are currently in clinical trials, most of which are in early stages such as Phase 1 or Phase 1/2.

For therapeutics, multinational pharmaceutical companies Eli Lilly and Regeneron are conducting Phase 3 clinical trials for antibody therapeutics and have received emergency use authorization in the United States. Clinical trials are also underway to add COVID-19 treatment efficacy to existing drugs such as 'Baricitinib,' a component used for arthritis treatment.

In Korea, a total of 15 products (13 ingredients), including antibody therapeutics being developed as new COVID-19 treatments, are in clinical trials.

This content was produced with the assistance of AI translation services.