Page 133 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Annex

Time Summary
List of Article 102 of Pharmaceutical Affairs Act remote areas where practicing
October 5
pharmaceutical personnel are not available
Revise “Import Regulations for Commodities Containing F01 and F02
October 6
Category List Import Commodity Classification of Republic of China”
Promulgate “Regulations for Chinese package insert amendments on dose
October 12 forms of systemic administration (oral intake, injections and suppositories) of
NSAIDs (except aspirin) prescriptions”
October 14 Establish “Guidelines of Cosmetics for Safe Children Use”
TFDA food cloud was rewarded of 4 star certificate of the Euro Cloud Star
October 19 Audit (ECSA), Secretary-General of TFDA attended the ceremony for
certification
Host the conference of “2016 Global health forum in Taiwan – Medicinal
Product Accessibility and Quality Management”
October 24
Host the conference of “APEC Seminar on the International Cooperation
Experiences in Addressing Trade and Regulatory Issues of Medical Products”
Revise Table 1 in Article 3 and Table 5 in Article 6 of “Standards for Pesticide
October 26 Residue Tolerance”, add and revise pesticide residue tolerance of 14
pesticides in 85 vegetables, fruits and corn products
Revise “Import Regulations Containing 508 in Import Commodity Classification
November 1
of Republic of China”
Establish “Technical Guidelines for Cosmetics UVA Sunscreen Performance
November 8 Tests (Human Subject Test)” and “Technical Guidelines for Cosmetics
Sunscreen Performance Tests (Human Subject Test)”
Host the international conference “2016 International Conference on TPP/
November 10
RCEP, Medical Products and Food Safety”
Promulgate “Regulations for package insert outer box format of Over-the-
November 16
counter drugs – Staged (in years) schedules and measures”
November 23 Promulgate “Revision of Chinese Package Insert of Corticosteroid Injections”
November 30 Host 2016 “Seminars of ASEAN Medicinal Products Provisions”
Establish “Pharmaceutical Affairs Act Article 2.2 - List of essential medicinal
December 6
products ”
Revise Article 3, Table 1 of “Standards for Pesticide Residue Tolerance”, add
December 12 and revise 8 pesticide residue tolerances in 25 vegetables and fruits, and
define pesticide residue of Metolachlor.
Revise “The Food Businesses Which Import Food and Genetically Modified
Food Raw Materials Shall Keep the Relevant Records, Documents and
December 14 Electronic Files or Databases of the Imported Products”
Host the wrap-up presentation of “Improvement of Food Distributors
Management” during 2016
Revise “Regulations of Labeling Requirements for Special Dietary Food for
December 19 Patients", and rename the regulations as "Regulations Governing the Labeling
of Formula for Certain Disease”
Revise part of the regulations for “GMP (Part I. General Principles) and (Part
December 26
II. API)”

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