The agreement is designed to facilitate the bilateral trade in medicinal products between Switzerland and Korea and reduce the workload of the relevant authorities in authorising and monitoring medicinal products. It creates the legal basis for enabling the contracting parties to mutually recognise inspection results relating to Good Manufacturing Practice (GMP) for medicinal products and share information, documents and inspection reports.
In Switzerland and Korea, medicinal products must be manufactured in accordance with international GMP regulations. Compliance with these regulations is essential for authorisation. Consequently, the production sites of the medicinal product manufacturers are regularly inspected by the relevant authorities.
To avoid time-consuming inspections in the other respective contracting state in the context of international trade, the agreement between Switzerland and Korea specifies that the relevant authorities will rely on each other’s inspection results relating to GMP in the form of certificates. Swissmedic is responsible for implementing the agreement.
In a constantly evolving regulatory environment, and given the increasingly complex requirements pertaining to therapeutic product development and production, international collaboration is vital for staying on top of the growing challenges. Swissmedic has thus been endeavouring to improve cooperation with partner authorities abroad for several years.