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Terms and Definitions Related
Terms and Definitions Related to New Drugs
Terms and Definitions Related
Terms and Definitions Related to New Drugs
【Update Date:
2018-10-18
】
unit:藥品組
New Drug-related:
New drugs: The term "new drugs", as defined in Article 7 of the Pharmaceutical Affairs Act, refers to drugs that involve preparations having new compositions, new therapeutic compounds, or new methods of administration, as verified and recognized by the central competent heath authority.
New indications: Includes supplements or amendments to indications.
Bio-pharmaceuticals: Sera, antitoxins, vaccines, toxoids, bacterial liquids and other products manufactured in accordance with principles of microbiology and immunology.
Radiopharmaceuticals: Radioactive material-containing drugs that meet the definition of drugs stated in Article 6 of the Pharmaceutical Affairs Act and which can be used to diagnose, monitor, treat or relieve diseases or have other medical efficacies upon use within the human body.
Batch-sealing of biological preparations (Article 74 of the Pharmaceutical Affairs Act): No serum, antitoxin, vaccine, toxoid or drug produced either microbiologically or immunologically may be put to sale, unless each lot of such drugs has been sample-tested after importation or manufacturing, and then found to meet standards and batch-sealed by the central competent health authority.
Pharmacovigilance period: For a new drug having been approved during registration review and issued a permit, the pharmacovigilance period is 5 years starting from the date the permit is issued.
Pharmacovigilance period: For a new drug having been approved during registration review and issued a permit, the pharmacovigilance period is 5 years starting from the date the permit is issued.