MFDS to shorten fast-track review by a month

Temporarily prioritizing COVID-19 treatment and vaccine

NIFDS forms ‘Fast-track Review Division’ and ‘Preliminary Consulting Division’ and set relevant regulations

MFDS to give online presentation on Sept. 9

With the latest reorganization effective from Aug.

 

31, South Korea’s Ministry of Food and Drug Safety (MFDS) has formed ‘Fast-track Review Division’ and ‘Preliminary Consulting Division’ under National Institute of Food and Drug Safety Evaluation (NIFDS) to expedite the review process on innovative new drugs.

 

The pharmaceutical industry is expecting the fast-track review on Korean-made new drug and incrementally modified drug (IMD) would expand as MFDS has added ‘new drug developed by Innovative Pharmaceutical Company’ to the expedited review subject scope.

 

However, MFDS clarified only the drugs defined under the Article 58 of Pharmaceutical Approval Review Regulation are eligible for the fast-track review, which means even a new drug developed by an innovative pharmaceutical company may not be eligible for the fast-track review unless the regulation defines so.

 

Recently, the pharmaceutical industry’s anticipation was heightened as MFDS newly established an operational plan to provide fast-track review on healthcare products meeting any one of following conditions—pharmaceuticals aiming to treat life-threatening diseases or severe diseases (including orphan drug or orphan drug in development), and have no alternative option or demonstrate efficacy significantly better than the existing option; pharmaceuticals aiming to prevent or to treat infectious disease with risk of threatening public health, such as bioterrorism or infectious disease pandemic (including outbreak of infectious disease with potential to develop as a pandemic), and have no alternative option or demonstrate efficacy significantly better than the existing option; new drugs developed by an innovative pharmaceutical company; rare medical devices; innovative medical devices; and innovative healthcare products with convergence technology.

 

The MFDS operation plan would have the ministry to designate subjects for fast-track review among products the companies applied for.

 

A MFDS official said, "The operation plan would cut the current fast-track review period by 30 days from 120 days and complete it in 90 days.” And the applicant may accelerate the commercialization by having a pre-review consulting and fully preparing for the review without submitting supplementary materials.

 

The Korean pharmaceutical industry seems to be anticipating on adding ‘new drugs developed by innovative pharmaceutical company’ as subject for the fast-track review.

 

So far, 31 companies—mostly Korean companies like Hanmi Pharmaceutical and Yuhan—are designated as ‘innovative pharmaceutical company.’ Moreover, MFDS elaborated IMDs could also be designated to take the fast-track review.

 

Such MFDS regulation on fast-track review is nothing new.

 

But such specific application procedure for pharmaceutical company did not exist.

 

The fast-track review regulation is described in Article 58 of the Pharmaceutical Approval Review Regulation According to the regulations, companies with following pharmaceuticals may apply for the fast-track review—pharmaceuticals with treatment efficacy expected on life-threatening or severe diseases such as AIDS or cancer; urgently needed pharmaceuticals due to existing treatment options unable to treat or tend to develop resistance; and pharmaceuticals the Minister of Food and Drug Safety deems necessary for patient treatment or industrial development, such as anticancer treatment, orphan drug and DNA chip.

 

Some of evidential materials can be submitted after the market release, and the review process can be prioritized to accelerate the procedure.

 

Moreover, the regulation clarifies, the fast-track review would be accessible to pharmaceuticals meeting the following conditions—new drug or IMD; pharmaceuticals submitted evidence on clinical trial outcome conducted in South Korea; pharmaceuticals underwent preliminary review on evidential material submission standards regarding toxicity, pharmacology test, and clinical outcomes according to the Article 35-2; pharmaceuticals, applicable by Item 3 of Paragraph 2 of Article 25, that submitted common technical document (CTD) according to Paragraph 1 of Article 6.

 

But as the fast-track review is not stipulated in the Pharmaceutical Affairs Act, the ministry would have limitations in expanding the system.

 

Regarding the limitation, the ministry is in process of supporting a lawmaker’s bill.

 

On the contrary, fast-track reviews on cell and gene therapies are stipulated under the recently legislated Advanced Regenerative Medicine and Biopharmaceutical Act.

 

The newly established Fast-track Review Division would not handle pharmaceuticals managed under the Advanced Bio Act, but the Cell and Gene Therapy TF Team would process their fast-track review under the new law.

 

For the time being, the Fast-track Review Division plans to prioritize and review COVID-19 treatments and vaccines over other subjects.

 

A MFDS official noted, "The COVID-19 treatment and vaccine would be processed first,” and “the fast-track review subjects stated by the operational regulation would be processed under the Article 51 of Pharmaceutical Review and Approval Regulation." Meanwhile, MFDS plans to hold an online seminar on the issue from Sept.

 

9 to 10 to inform about the preliminary consulting and fast-track review system and related procedure in detail.