The Korea Biomedicine Industry Association on the 3rd welcomed the passage in a National Assembly plenary session of the Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing corporations, known as the CDMO special act.
On the 2nd, the National Assembly passed as introduced a bill led by 12 members including Han Ji-a of the Health and Welfare Committee at the 14th plenary session of the 429th regular session, with 233 votes in favor and 2 abstentions out of 235. The law will take effect one year after promulgation.
With the enactment of this special act, the Ministery of Food and Drug Safety will introduce a registration system for biopharmaceutical export manufacturers to streamline customs clearance procedures and establish a legal basis for good manufacturing practice (GMP) compliance certification for CDMO manufacturing sites.
The special act also includes the introduction of a raw material certification system and the designation of institutions for training specialists, such as the Vaccine Safety Technology Support Center.
Calling it "the first standalone law for the domestic CDMO industry," the association said it expects "to reduce administrative expense caused by overlapping regulations and to create a predictable regulatory environment that reflects the characteristics of the CDMO industry."
The association added, "As the biopharmaceutical production cluster built around Songdo secures an institutional footing, international competitiveness will be strengthened and entry into overseas markets will accelerate," and analyzed that "establishing a legal basis for the raw material manufacturing and quality certification system will also contribute to promoting localization and stabilizing supply chains."
Lee Jeong-seok, president of the Korea Biomedicine Industry Association, said, "The passage of this special act is a historic turning point that completes the institutional foundation for Korea's bio CDMO industry to lead the global market," and added, "We will work closely with the government so that industry opinions can be faithfully reflected in the enforcement decree and enforcement rules during the implementation of the law."