Korean Regulatory Overhaul To Cut Drug RnD, Approval Time
This article was originally published in SRA
The South Korean government has unveiled a series of regulatory reforms that are designed to step up the competitiveness of the pharma industry and supply drugs in time for public health emergencies.
The government plans to shorten the approval time for conducting clinical trials by engaging in preliminary consultative discussions with companies, under which applicants may be asked to improve their clinical trial plans. As a result, it expects to shorten the average clinical trial approval period to 55 days, from 67 days now.
The government also plans to adopt a priority approval system for medicines that cannot undergo clinical trials for whatever reason, and will change rules to allow the granting of approvals to medicines for use in public health crises based on non-clinical results. Such drugs are expected to include those to treat or prevent diseases such as emerging infections, or for use in biochemical terror attacks, in both cases with a significant impact on public health.
To promptly supply these products during a time of public health crisis, their efficacy will be evaluated based on animal test results only, and then additionally verified when they are actually used.
Expanding Conditional Approvals
In addition, the Ministry of Food and Drug Safety said it would expand a conditional approval system for therapies for life-threatening diseases. Under this, approvals would be granted to products for disorders such as Alzheimer's disease or cerebral infarction based on Phase II clinical results only, on condition applicants submit Phase III and other necessary data after the launch.
At present, the government grants conditional approvals only to oncology and orphan drugs as well as autologous chondrocyte cell therapies.
By including products for life-threatening or irreversible diseases to the conditional approval list, the government expects to bring forward their market entry by two to three years. Going forward, the government also plans to include on the list novel biologics for infectious diseases.
Faster Drug and Device Approvals
To shorten the drug approval periods, the ministry will allow companies to conduct good manufacturing practice evaluations of biologics before they file for regulatory approval of the products, a step that is expected to bring forward market entry by up to 70 days.
The latest measures come after the National Institute of Food and Drug Safety Evaluation, which is part of the MFDS, said recently that the government will draw up detailed guidelines for a fast-track drug review and approval system this year1.
The hope is to increase applications submitted for review, provide the pharma industry with a clearer understanding of the process, and provide timely patient access to more treatment options.
For the industry, it has so far been unclear 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 NIFDS at the time.
Shortening Product R&D Periods
As one of its steps to shorten product R&D periods, the government will improve conditions for the use of embryos in the development of stem cell-based therapies. When it is difficult to confirm the medical history of embryo donors, the government will allow safety tests on the preserved embryonic cells to enable use.
At present, embryos donated a long time ago could not be used at all in the development of stem cell therapies due to scrapping of donors' medical records.
"In particular, social demand is rising for supply of therapies in time for outbreaks of new infectious diseases and biological terror attacks. The need to beef up competitiveness of the industry through prompt commercialization of latest biologic medicines is also increasing," said the MFDS.
South Korea has been notching up its fight against infectious diseases after suffering from a massive outbreak of Middle East respiratory syndrome (MERS) in 2015.
References
1. Korea To Bolster Fast-Track System With Speedier Drug Approvals In Mind, Scrip Regulatory Affairs, May 3, 2016
This article has also been published in PharmAsia News. Scrip Regulatory Affairs brings selected complementary coverage from our sister publications to our subscribers.