Fast-track Review of COVID-19 Vaccines in Korea

As the Korean government preorders COVID-19 vaccines ahead of formal regulatory approval, the Ministry of Food and Drug Safety (“MFDS”) prepares to speed up review for timely production and commercial launch of the vaccines.

The MFDS has indicated that the preordered vaccines will be reviewed under its fast-track review and approval system, which will shorten the standard review period to two months.

The Korean Government’s Preorder of COVID-19 Vaccines

On December 8, 2020, the Ministry of Health and Welfare (“MOHW”) stated that it has preordered 64 million doses of vaccines from four pharmaceutical companies – AstraZeneca Inc., Pfizer, Johnson & Johnson's Janssen and Moderna.

MOHW has reportedly executed an advance purchase agreement with AstraZeneca and is expected to execute a similar agreement with each of the other three companies by the end of 2020.  According to the government, the preordered vaccines, together with additional vaccines to be supplied through the World Health Organization’s global vaccine project (the COVAX Facility), should be sufficient to cover 88% of Korea’s population, and are expected to be produced in Korea or imported into Korea in stages starting as early as February 2021.

Regulatory Requirements for Vaccine Registration in Korea

Importing, manufacturing and/or selling pharmaceutical products in Korea involves multiple approvals and authorization from MFDS (i.e., marketing authorization), including import license, manufacturing license, and/or a license for selling products made by way of consignment manufacturing.  Each such authorization requires submission of various supporting documents to MFDS, including materials evidencing product safety and efficacy, quality control standards and clinical trial results.

Such an extensive review process typically takes at least 6 months or longer.  In particular, approval of vaccines additionally requires a final authorization step known as “lot release (or batch release)” prior to commercial launch.

The COVID-19 vaccines preordered by MOHW are yet to obtain MFDS’ marketing authorization.  However, given the urgent demand for a vaccine, MFDS has also been working in parallel to expedite requisite review processes.  In October 2020, MFDS formed a specialized team (the “COVID-19 Review Team”) for fast-track review and approval of applications to conduct clinical trials for COVID-19 vaccines.  With respect to MOHW’s preorder of COVID-19 vaccines, MFDS has indicated that it is set to conduct fast-track review of marketing authorization applications and lot release and grant approval within a couple of months. 

MOHW has also indicated that, if necessary, it will negotiate with additional vaccine manufacturers in the near future.

As such, pharmaceutical companies looking to export or sell COVID-19 vaccines in Korea should be kept informed of the relevant procedures to expedite any applicable review processes.

Considerations for Pharmaceutical Companies

• Fast-track review for clinical trial applications​
  

       - MFDS has formed the COVID-19 Review Team for fast-track review and approval of clinical trial applications for COVID-19 vaccines.

       - Additional information on the COVID-19 Review Team’s procedures can be found on MFDS’ (in Korean), or by email inquiry to.

      - MOHW has also formed a task force to assist facilitation of clinical trial processes.

• Fast-track review for marketing authorizations​
  

      - Expedited review of applications for marketing authorizations will also be available through MFDS’ fast-track review system.  Generally, fast-track review of marketing authorizations is available for a pharmaceutical product that is (i) developed to prevent or treat an infectious disease that may cause serious harm to public health, and (ii) if there is no existing treatment (alternatively, if the mechanism of the product is entirely new compared to any existing treatment or shows a substantial improvement in the effectiveness of treatment).

      - MFDS has stated that the production and commercial launch of vaccines would be significantly delayed under standard review processes as review for marketing authorization in principle begins after the completion of extensive three-phase clinical processes.  Under MFDS’ fast-track review system, MFDS would begin to preliminarily review nonclinical data about 90 days prior to the anticipated submission of a formal application for marketing authorization.  MFDS has confirmed in late October 2020 that it has begun a preliminary review of a COVID-19 vaccine being developed by AstraZeneca for fast-track approval.

      - MFDS has stated that the COVID-19 vaccines preordered by MOHW will be reviewed under its fast-track review system.  The vaccine suppliers (AstraZeneca, Pfizer, Janssen and Moderna) are expected to submit applications for market authorization around early 2021 for timely approval and launch in the Korean market.

      - To request expedited review of marketing authorization applications, applicants should request prior consultation with the MFDS and apply for such fast-track review in line with an.

• Mid-trial review of applications for marketing authorizations​
  

      - Although results of three-phase clinical trials are required to apply for a marketing authorization, upon consultation, MFDS may accept phase-2 clinical trial results for review and possible approval in case of confirmed efficacy by the phase-2 clinical trial.

      - Such mid-trial review is subject to the conditions of phase-3 results being submitted in due course and the approach and purpose of the phase-2 clinical trials being similar to those of phase-3.  (Submission of the phase-3 data may be post commercial launch in Korea, in case of a new imported drug.)

      - To request use of phase-2 results for review and approval of a COVID-19 vaccine, once efficacy is established by the phase-2 clinical trial, the applicant should consult MFDS’ COVID-19 Review Team.

• Special import exception​
  

      - For import of pharmaceutical products, special import exceptions are also possible based on exigent circumstances upon decision by the minister of MFDS.  For example, this was the case with the Korean government’s import of remdesivir for Covid-19 treatment, prior to processing of the marketing authorizations.

• Other considerations: protection of COVID-19 vaccine manufacturers​
  

      - Indemnity: there are no special laws in Korea that protect or furnish indemnity to COVID-19 vaccine manufacturers.  However, vaccine suppliers may seek contractual indemnity clauses.

      - Vaccine compensation system: Under the Infectious Disease Control and Prevention Act, the government is required to provide compensation for vaccine-related injuries, subject to certain standards. The government can then seek subrogation to right against the vaccine maker.

For any additional information or questions concerning COVID-19 issues, please reach out to the BKL COVID-19 Response Team ([email protected]) or your BKL contact.