Korea Pharmaceutical and Bio-Pharma Manufacturers Association and Korea Trade-Investment Promotion Agency (KOTRA) Join Forces to Support Overseas Regulatory Approvals, Move to Ease Export Hurdles

\ \ [Financial News] The Korea Pharmaceutical and Bio-Pharma Manufacturers Association and the Korea Trade-Investment Promotion Agency (KOTRA) will strengthen support for domestic pharmaceutical and biotech companies seeking to expand overseas. They plan to provide country-specific information on pharmaceutical regulations and approval procedures, and identify opportunities to cooperate with local organizations and companies, with the aim of reducing difficulties encountered during the export process.
The Korea Pharmaceutical and Bio-Pharma Manufacturers Association said it signed an MOU with KOTRA on the 14th at the Chuncheon Bioindustry Foundation in Chuncheon, Gangwon Province, to support domestic pharmaceutical and biotech companies’ overseas expansion and help resolve challenges they face.
The agreement was drawn up to support companies struggling with pharmaceutical regulations and approval procedures that differ from country to country. Commissioned by the Ministry of Food and Drug Safety, the association launched the Pharmaceutical Export Regulatory Support Office in January this year. The office provides country-specific regulatory information and helps address difficulties faced by companies.
The two organizations plan to strengthen their support system for overseas expansion by linking the association’s office with KOTRA’s K-Bio Desk. The K-Bio Desk is a network of trade offices specializing in the pharmaceutical and biotech sectors, established in seven countries, including the United States, Germany and Japan. It provides information and related support on local approval procedures for pharmaceuticals and medical devices.
Under the agreement, the two organizations will share country-specific market trends and information on regulations and approval procedures, and work to identify demand for cooperation with global pharmaceutical companies and pursue partnerships. They also plan to build a foundation for cooperation with regulatory agencies in major countries and run seminars and consulting programs on approval procedures in collaboration with foreign governments and relevant organizations, as well as local specialist consulting firms.
The plan is to coordinate services needed for overseas expansion, from providing regulatory information and identifying local partners to helping companies with difficulties that arise during approval procedures.
Noh Yeon-hong, chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, said, "To expand into global markets, it is important to improve access to information about each country's regulatory and approval environment and to build a foundation for effectively addressing difficulties in the process of expanding overseas." He added, "We will strengthen a support system that companies can feel the practical impact of."
Meanwhile, the agreement ceremony was held as part of the "Gangwon Region Growth Engine Bio Industry Promotion Agreement Ceremony." Attendees included Association Chairman Noh Yeon-hong, KOTRA President Kang Gyeong-seong, Minister of Trade, Industry and Energy Kim Jeong-gwan, and Minister of Food and Drug Safety Oh Yu-kyeong.

[email protected] Jeong Sang-hui Reporter