Commissioner Yoo-Kyung Oh Strengthens Ties with EMA and DG SANTE for Enhanced 해외 바카라 사이트 Sharing on Pharmaceutical Safety

해외 바카라 사이트

Commissioner Yoo-Kyung Oh of the Ministry of Food and Drug Safety (해외 바카라 사이트) embarked on a significant visit to Brussels, Belgium, on April 25th, aimed at solidifying a confidentiality agreement with the European Medicines Agency (EMA) and the Directorate-General for Health and Food Safety (DG SANTE). This pivotal agreement facilitates the exchange of non-public pharmaceutical information between South Korea and the EU.

Under the terms of the agreement, the 해외 바카라 사이트, DG SANTE, and EMA commit to sharing confidential data encompassing various aspects of pharmaceuticals, including safety, efficacy, and quality. This includes but is not limited to marketing authorization approvals, clinical trial authorizations, adverse event reports, pharmacovigilance data, regulatory policies, as well as information regarding investigations, recalls, and risk assessments.

The 해외 바카라 사이트 has been actively engaged in information exchange with the EMA since June 2020, particularly focusing on pharmaceuticals pertinent to combating the COVID-19 crisis, including vaccines. Since March 2021, collaborative efforts have intensified with working-level meetings aimed at expanding the scope of information exchange to encompass all pharmaceutical products. This has culminated in the preparation of a formal draft of the confidentiality agreement.

Notably, the 해외 바카라 사이트 expressed its satisfaction in fostering a robust relationship with DG SANTE and EMA, laying the groundwork for potential mutual recognition agreements (MRAs) across diverse fields, including medical products. Such collaborations are underpinned by mutual trust between institutions.

Commissioner Yoo-Kyung Oh emphasized the significance of the agreement, stating, "Through this partnership with European regulatory agencies, we anticipate that our capacity to swiftly address quality concerns and disseminate safety information pertaining to pharmaceuticals will be greatly enhanced. The 해외 바카라 사이트 is committed to proactive regulatory diplomacy aimed at bolstering global confidence in Korean pharmaceutical regulatory standards, thereby facilitating the international expansion of Korean pharmaceuticals."

Additionally, Commissioner Oh utilized the visit to discuss proposals for mutual recognition agreements (MRAs) and collaborative initiatives with key EU counterparts. These discussions encompassed proposals for the mutual recognition of Good Manufacturing Practice (GMP) inspections and joint efforts towards the development of guidelines for the regulation of AI-based medical devices.

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