Sustainable Drug Supply

Guided by our mission” Contributing to Better Health All Over the World” we actively advance sustainability strategies, address stakeholder priorities, and pursue balanced growth across economic, social, and environmental dimensions.

Supply Chain Management

Product Quality and Safety

Responsible Product Sales

New Drug Research and Development

Access to Medicine

Zero

Serious customer complaints reported in 2024

Commercialized products in CDMO Business in 2024

Zero

Product recalls due to adverse events in 2024

Inspections passed globally
with all manufacturing sites meeting standards
from the USFDA, EMA and TFDA

0 +

ANDA demonstrating our proven development capabilities

Status	Concrete Actions for Legal Compliance	Pharmaceutical Product Lifecycle	International Local and Internal Ethical Standards
Before Market Launch	New drug development and preclinical research	Good Laboratory Practice (GLP) Non-clinical safety standards for drug testing established by regulatory agencies in each country’s animal laboratories	Ethical Guidelines for Preclinical Animal Testing Ethical Guidelines for Clinical Human Trials Conduct product evaluation, development, manufacturing, and application in accordance with regulations in various countries Establish a dedicated department for regulatory affairs Develop compliance procedures
	Clinical trials	Good Clinical Practice (GCP) Good Manufacturing Practice (GMP) Ethical principles of the Helsinki Declaration Regulations established by local authorities, such as Taiwan’s Regulations for Human Clinical Trials and Pharmaceutical Affairs Act
	Production and manufacturing	U.S. FDA 21CFR PIC/S GMP Japan’s Pharmaceutical Affairs Law Health Canada’s GMP Guidelines EU GMP
	Drug registration	US FDA 21CFR Pharmaceutical Affairs Act of the Republic of China Regulations for drug registration applications in various countries
After Market Launch	Marketing and sales	Internal Marketing Code of Conduct established based on international pharmaceutical marketing guidelines Pharmaceutical marketing must comply with the Pharmaceutical Affairs Act, and advertisement content must be reviewed by the Health Bureau Health supplements must adhere to the Food Safety and Sanitation Management Act and related health claims regulations, with misleading consumers strictly prohibited Good Distribution Practice (GDP) Ethical guidelines established by the World Health Organization (WHO) and various countries	Regular self-inspection and internal auditing Employee education and training Establishing and maintaining compliant distribution processes Selection and monitoring of suppliers and distributors Quality control and tracking systems Employee training and record-keeping
	Pharmacovigilance	Pharmacovigilance (Drug Safety Monitoring) Post-market safety monitoring of drugs or health supplements primarily relies on a pharmacovigilance system to ensure that the use of these products does not harm patients’ health. This includes collecting and reporting adverse reactions, efficacy, and safety data, and notifying relevant authorities. In Taiwan, relevant regulations include Article 64 of the Pharmaceutical Affairs Act, which requires drug manufacturers and importers to establish an adverse drug reaction reporting system. Good Pharmacovigilance Practice (GVP) Regulations established by local authorities, such as Taiwan’s Pharmacovigilance Management Measures The regulation of pharmaceutical advertising in the United States follows the Federal Food, Drug, and Cosmetic Act (FDCA), which provides the regulatory framework to ensure that advertisements must be truthful, fair, and accurately presented. Additionally, the Food and Drug Administration (FDA) imposes specific requirements on pharmaceutical advertisements, including risk disclosure and the presentation of information. The 2007 FDA Amendments Act (FDAAA) further reinforced compliance requirements for pharmaceutical advertising, significantly enhancing regulatory standards.	Good Pharmacovigilance Practice (GVP) Establish internal Standard Operating Procedures (SOPs) Adverse Events (AE) Management Develop cross-departmental collaboration processes to ensure the rapid transmission of safety information and decision-making.

Sustainable Drug Supply

Guided by our mission” Contributing to Better Health All Over the World” we actively advance sustainability strategies, address stakeholder priorities, and pursue balanced growth across economic, social, and environmental dimensions.

Supply Chain Management

Product Quality and Safety

Responsible Product Sales

New Drug Research and Development

Access to Medicine

Zero

Zero

Bora

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