Page 18 - 2017食品藥物管理署年報(英文版)

Regulation addition and amendment in 2016

Food

Food businesses that shall establish food safety
monitering plans and conduct tests and meet the Benefits
minimum testing cycle and other relevant matters ‧Construct food businesses mandatory
self-testing
Regulations Governing Traceability of Foods and
Relevant Products ‧Implement food traceability system, strength-
en raw material control
Rgulations for labeling of plastic utensils, containers or packaging, ‧Improve food labeling system, help consumers
special dietary foods, barley, tapioca starch, chocolate, fluorine and understand food information
iodine in salts, and creamer

Medicinal Products
Regulations for the format of outer box/package insert
of over-the-counter drugs
Benefits
‧Increase drug accessibility for the public
Expedited review system for new drug applications ‧Expedited review system for new drug
applications
Reporting and registration of essential drugs and ‧Reduce risks caused by medicinal product
Regulations governing project approval for drug shortage
manufacturing and import ‧Strengthen the needs of emergency drugs

Projects/regulations governing approval for manufac-
turing and import specific drugs

Medical devices

Guidance for Hyaluronic Acid Dermal Implant with
Drug
Pre-clinical Testing Guidance for Electrosurgical Benefits
Devices for General Surgery ‧Establish and recognize guidances for
medical devices, provide as references for
Technical Guidance for Human Leukocyte Antigen industries in product research and develop-
Typing System ment as well as preparation of documents
when applying for product registration.
List of Recognized Medical Device Product Guidances

Cosmetics

Safety guidelines of cosmetics for children use
Benefits
Baby Wipes are subjected to management as ‧Strengthen safety for children use
cosmetics ‧Strengthen safety management of national
cosmetic hygiene to better align with interna-
Add Ban on Animal Testing for Cosmetics in Statute for tional regulations
Control of Cosmetic Hygiene
Legal Environment and Registration
Registration 3,818 medical devices
Approve the 1 domestic “blood glucose monitoring system”
st
incorporating with a smart phone. The 1 global product
st
1,643 food additives “Testing reagents for methylated carcinogens” assisting physician in
performing cervical cancer screening. Strengthen review efficiency
1,172 medicated cosmetics 682 medicinal products
A total of 136 new drug approvals. Approval for new drugs with new
39 health foods ingredients account the most (44 cases). Actively
provide new treatment options to patients. Implement medicinal
product review system reformation