New Law to Shorten Time to Market for Biologics
The National Assembly is set to pass a bill on advanced biopharmaceuticals, which is intended to strengthen the global competitiveness of the Korean biotech industry.
The bill examination subcommittee of the Legislation and Judicial Committee of the National Assembly decided on April 3 to put the bill on “safety and support of advanced regenerative medicine and advanced biopharmaceuticals" (advanced biopharmaceutical law) on the agenda of the committee’s plenary session. As a result, the bill, which was proposed by Democratic Party lawmaker Jung Chun-suk in July 2017, is expected to pass the National Assembly's plenary session scheduled for April 5.
The advanced biopharmaceutical law unifies biopharmaceuticals-related regulations scattered in such laws as the Pharmaceutical Affairs Act, the Bioethics Act, and the Blood Management Act. The new law aims to update various drug regulations introduced long ago as biopharmaceuticals have emerged as Korea's next-generation growth engine.
The new law focuses on rational regulatory improvements. Through the newly introduced customized review system, biotech companies can submit their data at any time, even before the final clinical trial data is out, for review by the Drug Ministry. In addition, competitive new drugs get a priority over other drugs for screening, and new drugs that are essential to patients can be conditionally licensed without completing clinical trials.
Under the new law, it is also possible to prescribe biopharmaceuticals that are being developed or imported for clinical trials. This applies to life-threatening diseases that do not have alternative means of treatment, like patients suffering from terminal cancer or intractable diseases. In addition, biopharmaceuticals used as raw material pharmaceutical and produced in Korea for exports will be exempted from approval examination conducted every five years.
As such, once the new law is implemented, stem cell therapy companies, such as Medipost, Pharmicell, and Cha Biotech, as well as gene therapy companies, including Sillajen, Genexine, and Helixmith (formerly Viromed), will primarily benefit from it. The industry expects the law to shorten the time to market for advanced biopharmaceuticals by up to four years.