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2015 Annual Report

Food

Management

Medicinal

Products

Management

Controlled

Drugs

Management

Medical

Devices

Management

Risk Assessment

Management and

Research Outcomes

Cosmetics

Management

Appendix

National

Laboratory and

Testing Network

Risk Communication

and Consumer

Protection

International

Cooperation and

Cross-Strait Exchange

7

The safety, quality, and efficacy of food, drug and cosmetics are intimately related to public health.

A competent authority with comprehensive product management capabilities must effectively

control and manage marketed food, drug, and cosmetics, counter illegal drugs and violative foods,

conduct product health risk assessment and management, and prevent abuse of controlled drugs.

At the same time, in order to promote national biotechnology development, strengthen consumer

protection, and align the country's laws to global food and drug safety management trends, the

original Food and Drug Bureau was restructured to form the Taiwan Food and Drug Administration,

Ministry of Health and Welfare ("TFDA") with the goals of strengthening food and drug safety

management and establishing a unified regulatory mechanism.

Section 1. Policy Objectives and Focus Areas

The TFDA takes reference from administrative guidelines of the Executive Yuan, implementation

and development of related policies, and current social conditions to enhance food and drug

regulations, strengthen management over manufacturing plants, raw materials, and imported

products, effectively track product distribution, and establish transparency of product information

to safeguard consumer safety and provide the general public with an environment that promotes

Safe Food

and

Safe Drug

.

Administrative Objectives

1. Improve the comprehensiveness of management and risk assessment systems for food, drug,

and cosmetics; strengthen the management of raw materials and sources of food, drug and

audit the distribution of these products; rebuild the reputation of Made in Taiwan (MIT) food and

drug.

2. Promote interministerial collaboration; prohibit illegal drugs and intentionally adulterated food

products; strengthen controls over food and drug advertisements; achieve effective reduction in

drug abuse.

3. Establish a medicinal product review mechanism aligned with international trends; simplify drug

review procedures; achieve effective drug production management and safety monitoring; and

provide the public with safe and effective drug.

Administrative Highlights

1. Amendments to Product Management Regulations;

(1) Enhance the legal context for modern product review and management;

(2) Enhance the legal context for food management;

(3) Develop medicinal product technologies and conduct regulatory science research.

1

Policy and Organization

Policy and

Organization