Looking at the review date for GIFT No. 1 Lunsumio

It takes 86 days

|Interview| Park Jae-Hyeon, Head of Rapid Review Division, Ministry of Food and Drug Safety

Roche's data preparation period was 7 months

The reason it took 11 months to obtain approval

"The goal of the GIFT program is to shorten the general review period by 25%.

 

The statutory review period is 120 days for chemical drugs and 115 days for biopharmaceuticals, but GIFT items In the case of, the goal is to complete the review within 90 days.” Park Jae-Hyeon, head of the rapid review division of the Ministry of Food and Drug Safety, announced on the 3rd that the actual review period for Roche Korea's Lunsumio Injection, the first GIFT product to receive domestic product approval, took 86 working days.

 

GIFT's goal was to shorten the general review period by at least 25%.

 

However, if you look at the period from the expedited review designation on November 29th of last year to the actual approval, it took 11 months.

 

At first glance, you may question whether the expedited review is appropriate.

 

Manager Park said in a recent interview with Dailypharm, "Lunsumio was reviewed for about 86 working days.

 

As it is GIFT's first product, the licensing manager worked together to process it quickly," adding, "It took 11 months from designation to approval.

 

“When I looked at the reason why it took, it took about 7 months to supplement the new application’s data,” he explained.

 

According to the 'Drug Rapid Review Report' published by the Ministry of Food and Drug Safety this year, the time taken for rapid review during the drug review period, which generally takes 120 days, was 26.9 days for COVID-19 vaccines and treatments, and 81.5 days for other products.

 

However, this statutory review period does not include the data supplementation period.

 

The Ministry of Food and Drug Safety does not include the supplementation period in the approval review period under the current legal system.

 

Therefore, the Ministry of Food and Drug Safety's shortened expedited review period refers to the pure review period excluding the data supplementation period.

 

Manager Park said, “Shortening the review period is not an easy task,” and added, “The key is how well the applicant understands the supplementary matters and prepares the materials.” In particular, this year's expedited review designation has more than tripled compared to last year, and Manager Park said, "The pharmaceutical industry is interested and is applying for expedited review designation." He added, "It officially takes 30 days to review the expedited review designation, but the current employees' “Through our efforts, we are completing the designation without completing 30 days,” he said.

 

These days, it is said that an increasing number of pharmaceutical companies do not immediately submit applications for approval even after receiving expedited review designation.

 

This is because each company has its own circumstances, such as taking the licensing step after understanding the global market.

 

Manager Park said, “After being designated for expedited review, the applicant must submit all documents related to the permit to the permit general manager before they are forwarded to the expedited review department.” “It’s going on,” he said.

 

As of November 6, there were 19 items designated as GIFT brands, but the rapid review department was newly established in 2020 and the number of items designated for rapid review is 44.

 

Once designated as expedited review, the Ministry of Food and Drug Safety shares the overall review schedule and holds product information sessions and supplementary information information sessions.

 

In addition, the review period will be shortened through 'rolling review', which reviews materials prepared through prior review.

 

Manager Park said, "It is meaningful that Runsumio was the first to receive approval under the GIFT name.

 

However, shortening the review period also requires efforts from the industry.

 

When the Ministry of Food and Drug Safety delivered the first review opinion, the parts that were not understood were discussed with the person in charge.

 

“I think it will be helpful if we communicate with each other to understand clearly and prepare materials,” he said.

 

Currently, items subject to GIFT are ▲medicines intended to treat serious or rare diseases such as life-threatening cancer, ▲intended for the prevention or treatment of infectious diseases that are likely to cause serious harm to public health, such as bioterrorism infectious diseases or infectious disease pandemics.

 

It is limited to ▲ new drugs developed by innovative pharmaceutical companies designated and announced by the Ministry of Health and Welfare ▲ combinations of drugs and medical devices subject to rapid review ▲ cases where there is no existing treatment or showing clinically meaningful improvement in effectiveness, etc.

 

compared to existing treatments.

 

Manager Park added, “We are receiving a request to expand the GIFT target as an industry suggestion,” and added, “It is not easy as we are conducting screening work with limited manpower, but we are making efforts.” ​.