MFDS Simplifies Import Procedures for COVID-19 Vaccines... Supports Rapid Approval and Supply
Exemption from Submission of Exporting Country Government-Issued Certificate When Importing Biological Products
[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety announced on the 5th that it will exempt the submission of certificates issued by the exporting country's government when importing biological products such as COVID-19 vaccines. This is to support faster approval and supply by evaluating independently of the approval status of overseas regulatory authorities.
The Ministry of Food and Drug Safety revised and implemented the "Regulations on the Review of Product Approval for Biological Products, etc." on the same day, which includes these provisions.
Previously, only announced drugs could be used as reference drugs for equivalent biological medicines, but the ministry presented criteria allowing pharmaceutical companies to select new drugs or drugs equivalent to new drugs. Legal grounds were also established to allow Phase 3 clinical trials to be replaced with Phase 2 clinical trial data for evaluation when there are no alternative drugs or when the number of patients eligible for clinical trials is extremely small. This aims to alleviate difficulties in approving treatments for rare and intractable diseases and expand treatment opportunities for patients.
Precautions for use are to prioritize the use of international medical terminology, and adverse events have been improved to provide medical information by subdividing terms and incidence rates according to internationally harmonized standards. A "meeting application system" was also newly established to allow applicants to request explanatory meetings with the responsible department after applying for new drug product approval.
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An official from the Ministry of Food and Drug Safety said, "We expect this revision to contribute to improving public health," and added, "We will continue to refine the system to supply medicines with secured safety, efficacy, and quality through scientific review-based product approval and review of biological products, etc."
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