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Food and Drug Administration
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Annex Table 7. Status of amendments of pharmaceutical affairs regulations
in 2014
Date
Regulation / standard name
Summary
22
January
Regulations Governing Warnings
in Advertisements for Orally
Administered western medicine
Containing Alcohol or Chinese
Medicinal Liquors
Advertisement regulations for orally administered western medicine
containing alcohols (including amino acids and multi-vitamin
nutrient supplements) were amended accordingly to prevent
excessive consumption and workplace accidents amongst the
workers
14
February
Regulations for Registration of
Medicinal Products
Added definitions for biosimilar and categorized such
pharmaceutical products as a genetically engineered drug
according to their characteristics. Amended Attachment 6
Information Documents to be Attached for the Registration of
Biopharmaceuticals in Article 41
21
February
Regulations Governing
Medicament Manufacturer
Inspection
Revised a number of articles in the Regulations Governing
Medicament Manufacturer Inspection according to the amended
Good Manufacturing Practices for Pharmaceuticals and
Regulations for the Issuance of Medicinal Products and Medical
Devices Manufacturing Licenses and Evidentiary Documents for
Good Manufacturing Practices
25
March
PIC/S: Guide to Good
Manufacturing Practice for
Medicinal Products (Part 1,
Annexes)
Promulgated amendments to a number of articles in the
PIC/
S Good Manufacturing Guidelines for Pharmaceuticals (Part 1,
Annexes)
. The title of the specifications was also changed to
PIC/
S: Guide to Good Manufacturing Practice for Medicinal Products
(Part 1, Annexes)
2
April
Penalty Standards for Violating
the Good Manufacturing
Practices for Pharmaceuticals
Stipulation of Penalty Standards for Violating the Good
Manufacturing Practices for Pharmaceuticals
7
May
Regulations for Registration of
Medicinal Products
Article 73 was amended, requiring all locally produced
pharmaceuticals to attach the entire prescription content when
applying for extensions
23
May
Regulations for Administration
Document Attachments for
New Drug Application and
Communication Channels
Provided by TFDA
Specification contents were revised to include
risk assessments
for delayed ventricular repolarization time, toxicological kinetics
testing
, and
immunotoxicity testing
guidelines and relevant
segments, and added Chapter V for
Specifications for Non-Clinical
Study of New Anti-Cancer Drugs
7
July
Guidelines for the Nonclinical
Pharmacology/Toxicology
Studies for Medicinal Products
Applications (Revision 5)
Specification contents were revised to include
risk assessments
for delayed ventricular repolarization time, toxicological kinetics
testing
, and
immunotoxicity testing
guidelines and relevant
segments, and added Chapter V for
Specifications for Non-Clinical
Study of New Anti-Cancer Drugs
17
September
Clinical Trial Application
Procedures and Review
Standards for Human Cell
Therapy Products
Defined and explained relevant information and contents required
when applying for clinical trials of human cell therapy products in
order to provide a reference for Principal Investigators preparing
application information for clinical trials
25
September
Regulations Governing Warnings
in Advertisements for Orally
Administered Liquid Agents and
Syrups Containing Codeine or
Caffeine
Formulated regulations on warnings that must be displayed
in relevant advertisements to prevent excessive or long-term
consumption of the specified pharmaceuticals as well as
subsequent addiction or dependence