Page 117 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Date Event summary
Revised drug categories applicable for Rare Disease and Orphan Drug Act (API name: Teri?unomide; Part III - Major Events
April 21
indication: complex, multiple sclerosis).
April 27 Revised Sanitation Standard for Food Cleansers.

Organized the APEC Conference on Management and Related Scienti?c Detection of Food Additives in
April 29
Foods.
May 5 Organized the International Conference on Drug Supply Issues.
Revised Article 9, Article 39 Article 2 and Article 40 Attachment 4 of the Regulations for Registration of
May 7
Medicinal Products.
Revised the Fee-charging standards for registration and review of modern pharmaceutical products and
May 13
medical devices.
Formulated Fee-charging standards for registration, review, and certi?cation for food products and food
May 26
additives.
Revised the Compliance items for the labeling of packaged foods containing genetically modi?ed food
materials and compliance items for the labeling of food additives containing genetically modi?ed food
materials.
May 29
Revised the Compliance items for the labeling of bulk foods containing genetically modi?ed food
materials.
Announced the Labeling requirements and enforcement date for class 3 food containers of reusable
plastic plates, bowls, and dishes described in Article 18 of the Act Governing Food Safety and Sanitation.
June 10
Announced the Scope and categories of medical devices of speci?c classes that may be sold via retail
at pharmacies. Pharmacies no longer need to re-submit applications for retail permits for class 1 medical
devices and class 2 and class 3 non-implanted medical devices.

Announced that from 2013, the proportion for the collection of funds for drug hazard relief shall be
adjusted to 0.0005 of the total sales of pharmaceuticals of the previous year.
June 14
Announced the addition of the MAT heat source testing method to the Chinese Pharmacopoeia.

Revised the Article 2 Attachment Table 1 and Article 3 Attachment Table 2 in the Standards for
June 18
Speci?cation, Scope, Application and Limitation of Food Additives.
Revised Articles 3 Attachment Table 2 of the Standards for Speci?cation, Scope, Application, and
Limitation of Food Additives.
June 24
Revised full text of the Standards for Pesticide Residue Limits in Foods.
Established the Inventory Data of Burn Medication and Medical Supplies on TFDA of?cial website to
June 28
provide information and allocate medical supplies for burn treatments.
Initiated emergency acquisition of skin tissue in separate batches to treat victims of the Formosa Fun
Coast dust explosion.
June 30
Regulations Governing the Labeling of Soup Bases of Hot Pot at Food Vending Locations.

Hosted the Press conference of the Food Safety Month to support the Food Safety Challenge and jointly
July 1
defend food safety for the general public.
Revision of the Import Regulation of F01 and F02 in Import Commodity Classi?cation of Republic of China
July 8
by12 custms commodity codes. Including Dates and so forth.
Revised Methods for evaluating age delaying functions of health foods and renamed it to methods for
July 9
evaluating age delaying and healthcare functions of health foods.
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