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To ensure medication safety, NCPC has taken the lead in introducing the concept of "pharmacovigilance" in China and participated in the establishment of the "Guidelines for Rapid Reporting of Adverse Drug Reactions" in Hebei Province, which has been widely recognized by the industry.
NCPC’s pharmacovigilance system has recently obtained recognition from the Ministry of Health (MOH) of Moldova and NCPC has successfully passed the GVP system assessment and inspection from Moldova.
Early in in June 2022, MOH of Moldova reviewed the documentation materials provided by NCPC. In October, a remote inspection was conducted and the site evaluation and communication process were recognized by the Moldova authority and customer. NCPC International Corp. carefully reviewed the suggestions proposed by Moldovan authority during the inspection, compiled and submitted required supplementary materials to Moldovan authority.
Now, Moldova authority has issued positive results of evaluation on NCPC GVP system and approved that business in Moldova market can be continued and the renewal registration of related products can be initiated.
It is the first time that NCPC GVP system to be evaluated by foreign regulatory authorities. The positive inspection conclusion from Moldova authority demonstrates that NCPC GVP system has been established and run well and complies with international regulatory requirements. Experience in collecting adverse reactions overseas has been accumulated, the foundation for GVP system construction in NCPC International Corp has been built through this inspection and regulatory compliance are guaranteed for NCPC developing exporting business of finished pharmaceutical products.