According to the Drug Administration of Vietnam (Ministry of Health), there are 114 recommendations from pharmaceutical enterprises in 2023 belonging to 4 major groups of issues: price management, pharmaceutical business, quality management, and drug registration.
Of which, the Department has resolved 63/114 recommendations related to procedures and regulations in pharmaceutical management and licensing; 51 recommendations were reviewed and feedback was exchanged.
Regarding the procedure for renewing the drug registration certificate (DKLH), the revised Pharmacy Law, effective from 2025, adds provisions: allowing establishments to continue using the DKLH after it has expired and has submitted an application for renewal according to regulations until it is renewed or has a document from the Ministry of Health; allowing renewal applications not to go through the Advisory Council for granting drug and pharmaceutical ingredient registration certificates (except in cases where it is necessary to continue assessing the quality, safety, and effectiveness). In addition, the time for processing applications is reduced from 3 months to 20 days for applications that change or supplement drug information, without affecting the quality, safety, and effectiveness of the drug.
The procedure for renewing the registration certificate aims to screen registered drugs to suit practical needs. Of the 13,974 drugs that have been granted registration certificates in the past 10 years, 1,685 drugs (12%) have never been produced.
Source: https://thanhnien.vn/nhieu-thu-tuc-hanh-chinh-thong-thoang-hon-sau-kien-nghi-tu-doanh-nghiep-duoc-185241222214701653.htm
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