Page 24 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

Registration applications 1,861
received

Review completed
(including applications received in 2015 1,870
and reviewed in 2016)

87.9％ Approved for registration 1,643

Note: Rate of approved for registration (%) refers to the number of
cases approved for registration to complete review cases

Figure 2-2 Registration of Food Additives in 2016

Section 2. Medicinal Products and Cosmetics Legal
Environment and Registration

Current Status

TFDA drafted the “Amendment of the Statute for Control of Cosmetic Hygiene”,
established the “Draft for Medical Devices Act” and revised management regulations
related to medicinal products to align with international management trend and improve
the comprehensiveness of the laws and standards. Pre-market registration and the
acquisition of marketing license are both required for the management of medicinal

products, medical devices and medicated cosmetics before manufacturing and sales.
Continuous and improved review and management are also required to ensure the quality
and safety of the products.

Policies and Outcomes

1. Medicinal products and cosmetics legal environment
(1) To improve the comprehensiveness of medicinal products legal environment

The added and revised medicinal product management laws and related
announcements in 2016 included 12 laws and regulations listed in Table 2-3:
“Determination Directions on Complex Drugs”, “Regulation for Drug Shortage
Management”, “Regulations for Medicinal Product Traceability or Tracking System
Management”, “Regulations for Implementation of Outer Box and Package Insert
Format of Western Over-the-Counter Drugs”, “Article 27.2 List of Essential Drugs in
Pharmaceutical Affair Act”, “Good Manufacturing Practice”.

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