Korea To Bolster Fast-Track System With Speedier Drug Approvals In Mind
This article was originally published in SRA
South Korea plans to draw up detailed guidelines for a fast-track drug review and approval system this year to increase applications for such reviews, provide the pharma industry with a clearer understanding of the process, and provide timely patient access to more treatment options.
"We have actually been carrying out fast reviews for the drugs that need to be supplied quickly to the nation. We are planning to expand such reviews, but with limited resources we won't be able to increase them noticeably for now. But we are headed in that way," stressed an official at the National Institute of Food and Drug Safety Evaluation's (NIFDS) department of biopharmaceuticals and herbal medicine evaluation, during a recent briefing on the review and approval of biologics in 2016.
Since the briefing was organized by the biopharmaceuticals and herbal medicine evaluation department, officials only discussed plans for biologics; the NIFDS itself is part of South Korea’s Ministry of Food and Drug Safety.
For the industry, it has been unclear as to which medicines are eligible for the fast review system and how this actually works in practice. The MFDS plans to proceed with work this year to improve the understanding and clarity of the system, said the official.
Triggered By Need
Like the US and Europe, South Korea’s fast-track approval system is used when certain drugs need to be urgently supplied, such as when there is a massive outbreak of infectious disease, a terror attack, natural disaster or large-scale accident. It is also applied to drugs that can treat patients who can't be treated with any other existing products.
If the drugs are substantially more efficacious and safer than existing options, they should go through the fast review system, the official said.
South Korea has suffered from outbreaks of infectious diseases such as H1N1 and Middle East Respiratory Syndrome (MERS) in the past 10 years. The country had approved treatments during the outbreak of A/H1N1 in 2009, but it didn't have any specific treatments or vaccines during last year’s outbreak of MERS.
The country already has relevant laws to manufacture, import and use unapproved drugs in case of national emergency, but the fast-track system hasn’t been used widely amid the lack of understanding. "The government is now coming up with a detailed process to promptly supply drugs in such cases," said the official.
Other Regulatory Plans
During the briefing, the NIFDS also laid out other plans in the works for this year. The MFDS is planning to hold official meetings with the industry to deal with their complaints and increase the predictability and transparency of drug approvals.
The ministry plans to expand the scope of instructions for the use of medicine and unveil more information in announcing the results of its reviews. It also plans to operate a consultative group on the technology of cutting-edge, combined biologics.
In addition, it will also disclose English-language review reports of all biosimilar products developed in South Korea on the MFDS website by the end of this year. So far, English reports for Celltrion Inc.'s Remsima (infliximab) and Herzuma (trastuzumab) have been disclosed.
Meanwhile, the NIFDS has called for the need to increase the biologics review workforce to deal with rising complaints from the industry and to ensure the faster handling of reviews and approvals.
"As the biotech business is a new growth engine for the country, it has been under the spotlight," said another NIFDS official during the briefing. "We are making diverse efforts to support the industry from early stage product development to approval...However, our review workforce sharply falls short of our work, while complaints are increasing from the industry. Our workforce is less than one 16th of the US [Food and Drug Administration's] review workforce for biologics. We need to boost our workforce to meet such demand," the official continued.
South Korea has been accelerating its efforts to nurture the biotech sector. Among recent moves, the Ministry of Science, ICT and Future Planning said in March that the country will further support the biotech industry by setting up a “control tower” designed to hone government policies and resolve industry concerns.
The government will also form a state and private sector committee to speed up R&D in precision medicine, while injecting around $47.4m into R&D projects involving biomedical technology over the next five years.
This article has been published in Pharm Asia News. Scrip Regulatory Affairs brings selected complementary coverage from our sister publications to our subscribers.