The government will ease regulations to allow biopharmaceutical contract development and manufacturing organizations (CDMOs) to produce products in line with the regulatory standards of overseas clients. By moving away from applying only domestic facility standards to also recognizing importing countries' regulations, the change is expected to reduce the burden on companies during global contract processes.
The Ministry of Food and Drug Safety announced on the 24th the legislative pre-announcement of the enforcement decree and enforcement rules for the "Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations (CDMO Special Act)." The move establishes detailed operating standards for the special act, which takes effect on December 31 next year, with the core aim of specifying a regulatory support framework tailored to Korea's export-oriented CDMO industry.
The most notable part of the proposed legislation is the facility standards for the "biopharmaceutical export manufacturing business." The ministry decided that while basic requirements such as workshops, testing and inspection laboratories, and storage facilities will follow Korea's Pharmaceutical Affairs Act framework, detailed standards may follow the regulations of the country to which drugs are exported. The measure reflects the characteristics of the CDMO industry, in which manufacturing and quality control standards differ from country to country.
Domestic CDMO companies often operate production facilities and quality control systems in line with the standards of client-country regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). With this improvement providing an institutional basis for operating production facilities in line with overseas regulations, it is expected to help win contracts from global clients.
Procedures to reduce companies' administrative burden were also prepared. Companies that undergo a preliminary review before applying for CDMO manufacturing and quality control conformity certification or raw material certification can omit some of the documents required for submission. Technical consulting will also be provided during the construction or expansion of manufacturing sites.
Active pharmaceutical ingredients needed for biopharmaceutical production, as well as raw materials such as cell lines and vectors, will be able to be imported more quickly through the "standard customs clearance report" of the Korea Pharmaceutical Traders Association.
In addition, the ministry plans to newly introduce CDMO manufacturing and quality control conformity certification and certification for raw materials such as cell lines and vectors, and to designate institutions such as the Vaccine Safety Technology Support Center as specialized personnel training bodies to operate field-oriented education.
"With the preparation of these subordinate regulations, we expect to specify the institutional foundation for the CDMO industry and enhance the global competitiveness of domestic companies," a ministry official said.
