A bill has been proposed to strengthen institutional support for Korean contract development and manufacturing organizations (CDMOs) of biopharmaceutical products, helping them sharpen their competitiveness in the global market.

Rep. Han Ji-ah of the ruling People Power Party (PPP), a member of the National Assembly Health and Welfare Committee, introduced the “Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations (Enactment Bill)” on Wednesday.

CDMO combines contract manufacturing organization (CMO) and contract development organization (CDO), which provides a service that provides drug production, development, and analysis support. The biopharmaceutical CDMO industry has been booming since the Covid-19 pandemic, and companies are increasingly entering the CDMO business.

Last year, the U.S. House of Representatives passed the Biosecurity Act, restricting transactions with Chinese companies. The move raised expectations that global CDMO companies will benefit and stressed the need for government support for Korean companies' strategies to expand exports and strengthen competitiveness.

The bill includes the establishment of an export manufacturing industry to promote biopharmaceutical exports and grounds for GMP compliance certification, operation of a biopharmaceutical raw material manufacturing and quality certification system, special import procedures for raw drugs and raw materials used in biopharmaceutical contract development and production, and customized technical support for CDMOs to build production facilities and strengthen their capabilities.

“We are proposing this bill to collect industry opinions on the support measures needed to survive competition in the CDMO industry with major developed countries and provide legal and institutional support for these measures,” Rep. Han said.

“Establishing a legal framework to support Korean CDMO companies will contribute to securing Korea's biopharmaceutical supply chain in terms of public health while creating an institutional environment for companies to expand exports and preempt global markets in a proactive and predictable regulatory environment,” Han added.