Medicine manufacturers in Switzerland and South Korea have to comply with the standards of good manufacturing practice (GMP). The GMP rules are agreed at international level (PIC/s). They ensure that products are manufactured and continuously monitored according to the quality requirements designed to protect patient safety. These rules must be followed during manufacture as a precondition for the approval of medicines by the national regulatory authorities. Pharmaceutical production facilities are periodically inspected by the certifying authorities, i.e. Swissmedic in Switzerland.
In December 2019, Switzerland and South Korea signed an Agreementon the mutual acceptance of inspection results in relation to good manufacturing practice for medicinal products, meaning that these inspections do not have to be carried out on the territory of the other party.
The MRA requires the authorities concerned to refer to the results of inspections – in the form of certificates – carried out by the certifying authority of the other party. If necessary, the authorities will exchange the necessary documents concerning the inspection, provided that the company involved has given its consent.
The agreement thus facilitates trade in medicinal products between Switzerland and South Korea by reducing the administrative workload for both the industry and the competent authorities when authorising and monitoring medicinal products. In doing so, it also helps to strengthen global value chains and secure the supply of medicinal products.
Implementation of the GMP agreements in Switzerland is the responsibility of Swissmedic.
