Responsible Product Sales

Bora Group is committed to conducting marketing activities with integrity, transparency, and compliance, ensuring that all promotional information is accurate and balanced while striving to protect patient well-being and social interests. We established the ‘Group’s Marketing Code’ and the ‘Code of Conduct for Pharmaceutical Marketing,’ which require all employees and business partners to follow relevant rules and local regulations. Bora Group is committed to ensuring that all employees and third parties are responsible for adhering to this Code of Conduct and any stricter local laws or standards.

For products represented or distributed by Bora, the relevant marketing guidelines of the original manufacturer will be followed. Upsher-Smith Laboratories, our U.S. subsidiary, adopts the PhRMA (Pharmaceutical Research and Manufacturers of America) Code on Interactions with Healthcare Professionals (HCPs) and complies with relevant U.S. Food and Drug Administration (FDA) regulations, ensuring ethical engagement with the medical community. The company provides internal training and holds regular meetings to strengthen employee awareness of responsible product promotion practices. In Taiwan, Bora Health adheres to the Taiwan Food and Drug Administration (TFDA) regulations and references the Marketing Code established by the International Research-Based Pharmaceutical Manufacturers Association (IRPMA) to develop comprehensive internal operating procedures.

Bora Health, a subsidiary of Bora group, markets its products through a dedicated sales team and a broad network of distribution channels, including various levels of healthcare facilities (such as medical centers, regional hospitals, area hospitals, clinics, and pharmacies) and distributors. The company organizes or sponsors various therapeutic academic exchange activities and conferences to enhance healthcare professionals’ understanding and proper usage of its products. All marketing and sales activities comply strictly with relevant laws, regulations, and ethical standards, ensuring that interactions with healthcare professionals are centered on patient welfare and healthcare advancement.

Accurate drug labeling is essential for safe medication use. Clear, complete, and accurate labeling provides healthcare professionals with objective, truthful, and correct information, allowing them to provide appropriate care to patients. Patients can clearly understand the therapeutic effects of products, with all label information supported by evidence or scientific data. All Bora Group products are labeled 100% according to review guidelines, including product composition, indications, usage instructions, dosage, and precautions, with package inserts or leaflets included. All packaging follows the content approved by the Taiwan Food and Drug Administration (TFDA).

From January to October 2024, Bora Group did not violate any laws related to drug information, labeling, or marketing communications.

Bora Group strictly adheres to drug advertising regulations to minimize misunderstandings from improper advertising and has established internal standard operating procedures (SOPs) for staff to follow. All drug marketing advertisements are subject to approval by the health authorities, as required by the “Pharmaceutical Affairs Act”. When marketing or promoting products, the primary considerations are patient health and enhancing the quality of patient care. All product sales personnel undergo comprehensive training on product knowledge and adhere strictly to marketing regulations, ensuring that promotional efforts meet legal standards and reflect professionalism.

Marketing information must be clear, easy to understand, accurate, balanced, and complete, allowing recipients to grasp the product’s effects. Information should be evidence-based, with no false, exaggerated, or misleading claims. Events, such as seminars and annual meetings for healthcare professionals, must prioritize product information or provide scientific or educational content as their primary purpose. Product sales activities must follow the marketing plan, with a commitment and responsibility to provide objective, accurate, and truthful information to healthcare professionals. Relevant sales personnel receive quarterly training on product and disease knowledge

To safeguard drug safety and user health, Bora Group strictly follows regulatory requirements, and all products manufactured or sold have obtained TFDA licenses. From January to October 2024, there were no violations of any health and safety laws.

Bora Group supports drug manufacturers and suppliers by monitoring and reporting adverse drug reactions and product defects, acting as a communication bridge to provide investigation feedback to the marketing authorization holder or to Taiwan’s Food and Drug Administration’s “Drug Quality and Therapeutic Inconsistency Reporting System.”

To ensure medication safety, Bora Group has established a “Standard Operating Procedure for Drug Safety Monitoring” with a Drug Safety Team dedicated to handling adverse drug reactions. All reported cases are handled and documented in compliance with regulations to ensure every case receives full attention and appropriate action. Throughout this process, Bora Group strictly complies with personal data protection laws to safeguard consumer privacy and rights. From January to October 2024, there were no reports of adverse drug reactions.

To protect consumer rights and demonstrate Bora Group’s commitment to consumers, the company has developed “Complaint Handling SOPs” and “Recall Handling SOPs” for managing customer complaints or reports of defective drugs. These procedures ensure prompt investigation and effective corrective actions, retaining customer trust and supporting the company’s reputation.

From January to October 2024, Bora Group received six reports of defective drugs related to packaging defects or appearance differences, none of which affected user safety. No product recalls were necessary from January to October 2024.

Bora Health Inc. has set up a customer service hotline and contact email on its website, with designated personnel promptly addressing and responding to inquiries to ensure consumers’ concerns are resolved quickly. From January to October 2024, the company received at least 28 proactive emails, including questions about purchase locations and cooperation opportunities, all addressed within one business day.