Korean pharmaceuticals to benefit from expedited approvals in Ecuador and Egypt

The regulatory approval process for Korean pharmaceuticals in Ecuador and Egypt is set to become significantly faster, according to the Ministry of Food and Drug Safety (MFDS).

On Tuesday, the MFDS announced that Ecuador’s National Agency for Health Regulation, Control, and Surveillance (ARCSA) will officially recognize the Korean Pharmacopoeia as a reference standard starting June 30. This decision follows Ecuador’s revision of its biopharmaceutical sanitary regulations in December 2024, which formally acknowledged the credibility of Korea’s pharmaceutical testing methods.

With this change, pharmaceuticals adhering to the Korean Pharmacopoeia will be classified as “Official Medicines” in Ecuador, eliminating the need for additional validation of test methods.

Additionally, modifications related to pharmacopoeia standards in already-approved products will only require notification rather than a formal change application, significantly reducing time and costs for pharmaceutical companies.

Moreover, the World Health Organization (WHO) has included MFDS in its list of trusted regulatory agencies under the WHO Listed Authority (WLA) framework. As a result, pharmaceuticals approved by MFDS will qualify for expedited approval in Ecuador under the mutual recognition registration process.

In addition to Ecuador, Egypt has also strengthened its recognition of Korean pharmaceutical standards. According to MFDS, the Egyptian Drug Authority (EDA) added Korea to its “List of EDA Reference Countries” in July 2024.

The designation allows pharmaceuticals approved by MFDS to benefit from Egypt’s “Reliability-Based Expedited Review System,” which includes exemptions from manufacturing site inspections and simplified clinical documentation requirements.

“Ecuador’s recognition of MFDS as a reference agency and the inclusion of the Korean Pharmacopoeia in its regulatory framework is a major achievement in regulatory diplomacy.” Minister of Food and Drug Safety Oh Yu-kyoung said. “This accomplishment is the result of close cooperation between MFDS and the Korean Embassy in Ecuador and reflects international recognition of our regulatory expertise.”