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29
Food and Drug Administration
Publication
date
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Summary
June 25
Amendment for the Article
21 in the
“
Pharmaceutical
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Regulations
”
Excluding living animals for Pyrogen Tests is
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July 26
Regulations for Registration of
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Amendments for the articles 10, 46 and
70. Revise the rule for the pyrogen tests
preferred nonliving animal descriptions, and
the bioequivalence data requirements of
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post-market changes
July 30
Revise Article 3 of
“
Pharmaceutical
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Regulations
”
1. In coordination with the revision of Article 57
of the Pharmaceutical Affairs Act, the added
storage and distribution should be conform
to the provision of this guideline
2. Also, stipulate that operations and
regulations of manufacturing with
reference to the Pharmaceutical Inspection
Convention and Pharmaceutical Inspection
Co-operation Scheme (PIC/S)
August 14
Regulation for Accelerated
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Products
Created a mechanism for the express purpose
of meeting pressing medical treatment needs
of citizens. Used empirical evidence to select
surrogate endpoints which could reduce the
R&D timetable of medicinal products and allow
products to reach market earlier
September 4
Guideline for Review and
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Antibodies
A new guideline for the biological similarity
monoclonal antibody drugs for the
experimental and technical information
requirements for approval
September 25
The announcement regarding
the method and time frame on
good manufacturing practice
for
“
the manufacturers of Active
Pharmaceutical Ingredients
”
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and schedule in regards of the domestic
manufacturing and importing production
plants of western drug APIs