Page 116 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

List of Major Events in 2015

Date Event summary
Revision of the Import Regulation of F01 and F02 in Import Commodity Classi?cation of Republic of China
January 15
by 23 customs commodity code. Including Cocoa powder and so forth.
Formulated the Regulations on Nutrition Labeling for Prepackaged Vitamin and Mineral Tablets and Capsules.
January 23
Terminated the Standards on the Nutrition Labeling and Contents for Prepackaged Vitamin and Mineral
Tablets and Capsules.
Terminated the provision of Article 3 Paragraph 1 Subparagraph 4 for the Regulations of Inspection of
Imported Foods and Related Products where central competent agencies may require the obligatory
inspection applicant to attach evidentiary documentation when necessitated by considerations for food
January 26 sanitation and safety.

Formulated Evidentiary documentation that must be attached by the obligatory inspection applicant when
importing edible oils, special dietary foods, food in tablet or capsule forms, and other speci?ed imports.

Revised Articles 8, 48, and 25 of the Act Governing Food Safety and Sanitation.
February 4 th
Hosted the 8 Asia Regulatory Conference in collaboration with the International Federation of
Pharmaceutical Manufacturers & Associations (IFPMA).

Revised Article 3 Attachment Table 1 and Article 6 Attachment Table 4 of the Standards for Pesticide
February 12
Residue Limits in Foods.
February 16 Revised the List of Carrying Limits for Personal Medication of Arriving Travelers.

Formulated records, documents, digital ?les, or databases that must be retained by food businesses for
February 24
food imports (including genetically modi?ed food materials).
Formulated the Regulations on Nutrition Claim for Prepackaged Food Products and Terminated the
March 3
Regulations on Nutrition Claims for Conventional Foods.
Formulated clinical literature and data that must be provided when applying for changes of in?uenza
March 5
vaccine viral strains.
March 6 Revised a number of articles of the Regulation of Bioavailability and Bioequivalence Studies.
rd
Hosted the 3 PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) for Medicinal Products
March 24
which was attended by 47 inspectorate representatives from 25 countries.
Published the draft of the bilingual version (Chinese and English) of the Good Manufacturing Practice (GMP)
March 26
for Modern Pharmaceutical Products - Good Distribution Practice (GDP) Guidelines for Medicinal Products.
March 27 Organized the GDP International Conference.

Promulgated the termination of the Interpreted regulations for contents and food additives that must be
labeled according to Article 22 Paragraph 1 Subparagraphs 2 and 4 of the Act Governing Food Safety
and Sanitation.
April 7
Revised the Fee-Charging Standards for the Review of Medicament and Cosmetic Advertisements and
Fee-Charging Standards for the Registration of Cosmetic Products and Cosmetic Colorants.

April 8 Revised Articles 1 and 2 of the Regulations for Drug Injury Relief Application.
Stipulation to give import regulation F01 to CCC codes 3505.10.90.90-4 Other modi?ed starches and
April 10
3507.90.00.00-3 Other enzymes, and prepared enzymes
Revised items for the re-evaluation of drugs containing metformin.

Revised Article 46 of the Regulations for Registration of Medicinal Products.
April 15
All imported food products from Japan must be accompanied with evidentiary documentation, and
speci?c food products from speci?ed regions must also be attached with proof of radioactive inspection
before initiating import applications.
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