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GOVERNANCE
Risk Management

Risk Management

Hanmi Pharmaceutical operates an integrated risk management system that reflects the characteristics and strategies of its business to prevent and manage potential risks that may arise throughout the entire business process. Risks for each division are identified, assessed, and their response plans reviewed/implemented by dedicated organizations for each area. The monthly Executive Meeting comprehensively manages company-wide risks, including actual and potential risks that may arise across the entire business.


Risk Management System

Potential Risks

To prevent and manage potential risks that may arise throughout its business processes, Hanmi Pharmaceutical categorizes these risks into areas such as climate change, unfair trade, production stoppage, safety and health, information security, and quality, with each risk type monitored and responded to by a dedicated department. In particular, each classified risk is managed through a global-level risk management system by applying international standard management systems.

Category

Risk

Opportunity factors

Response Plan

Climate
Change
Risks

ㆍStrengthening domestic and international
regulations on greenhouse gas reduction
ㆍIncreased stakeholder demands related to climate change
ㆍNegative financial impact due to the introductionof
renewable energy, etc.

ㆍMeeting stakeholder expectations through proactive
response
Minimization of mid- and long-term financial impacts,
such as loss of assets from energy saving/ reduction.

ㆍOperation of ISO 14001
ㆍEstablishment and implementation of
carbon neutrality strategy
ㆍOperation of COST-Innovation

Domestic &
International
Macroeconomic
Risks

ㆍUncertainty in domestic and international
business due to political changes
ㆍDecrease in sales due to global economic recession

ㆍOpportunity to expand export countries and share
ㆍOpportunity for business portfolio diversification

ㆍPromotion of business portfolio diversification
ㆍExpansion of global network

Unfair Trade
Risks

ㆍViolation of fair competition rules for pharmaceuticals
ㆍIncreased promotion costs due to overheated competition
ㆍDamage to brand image and reputation

ㆍEnhancement of corporate value through
strengthened ethical sales practices
ㆍReduction of legal expenses through compliance
with regulations

ㆍEstablishment of ISO 37001
ㆍEstablishment of ISO 37301
ㆍPreparation of fair trade guidelines
ㆍEmployee training and monitoring implementation
ㆍOperation of a whistleblowing system

Production
Suspension
Risks

ㆍFacility damage and production disruption due to
typhoons, earthquakes, etc.
ㆍNegative financial impact due to production schedule delays

ㆍDisaster prevention
ㆍIncreased competitiveness due to rapid production
normalization

ㆍEstablishment of ISO 22301

Information
Security
Risk

Occurrence of various financial losses, such
as R&D key technology leaks, due to IT security
errors, personal info leaks, unusable systems, etc

ㆍMinimizing financial losses through the prevention of
personal information breaches
ㆍProtecting intellectual property rights through
the prevention of cyber terrorism
ㆍEnsuring stable production and business activities

ㆍOperating a dedicated information protection
department
ㆍEstablishing ISO 27001

Tax Risk Management

Hanmi Pharmaceutical diligently adheres to national laws, files tax returns, and fulfills its tax obligations for transparent and legitimate tax practices. Furthermore, it promptly and transparently provides data when requested for investigation or information by tax authorities.

Management Principles

1. Compliance with National Laws

2. Prompt and Transparent Provision of Information to Tax Authorities

3. Prior Review and Analysis of Tax Risks Internally and Externally

4. Adherence to Arm's-Length Principle for Related-Party Transactions

5. Managing International Tax Risks according to OECD Transfer Pricing Guidelines

Tax Risk Management Activities

Hanmi Pharmaceutical conducts prior internal and external tax risk reviews to prevent tax risks that may arise from business activities. It regularly seeks review and advice from external experts on significant tax issues that may arise during business operations. Particularly for domestic transactions, it maintains fair transaction prices in dealings with third parties and related parties in accordance with relevant laws, and for global business transactions, it prevents international tax risks based on expert advice and the OECD Transfer Pricing Guidelines. Internally, tax personnel are assigned to proactively manage tax risks through review and analysis of tax law amendments that occur annually.

Tax Risk Assessment

Hanmi Pharmaceutical makes its best efforts to fulfill its social responsibilities based on transparent and legitimate tax practices and internal and external tax risk management through external experts and internal tax personnel. It proactively reviews tax risks for important business matters such as transactions of goods and services, acquisition of shares, international transactions, pursuit of new businesses, and changes in transaction structures, and reflects the results of these reviews in final decision-making.


Accounts Receivable Risk Management

Hanmi Pharmaceutical manages accounts receivable risk for smooth fund operation through stable debt collection.

Accounts Receivable Risk Management Activities

Hanmi Pharmaceutical's accounts receivable management is carried out through business managers and the accounts receivable management department. Based on an 'accounts receivable management system' optimized for our business operations, we regularly check and manage same-day sales, revenue, adherence to client payment terms, client collateral management, and accounts receivable status. Furthermore, we make our best efforts to proactively respond to the risk of bad debt occurrence by cooperating with external credit rating agencies to frequently assess the management and business activities of our clients.


Risk Management through Global Standard Management Systems

Hanmi Pharmaceutical categorizes potential risks that may arise throughout its business operations into 6 major crisis response areas and 11 key risks, including environment, labor, fair trade, information security, disaster, and medical device quality. Each risk type is then assigned to a dedicated department for monitoring and response activities. By applying international standard management systems to address these classified risks, the company operates a global-level risk management system.

Hanmi Pharmaceutical's ISO (Global Standard Management Certification System) Certification Status

Key Risks

Certification
Name

Business Site

Validity Period

Content

Environment

Environmental
Pollution
Minimizing
Environmental
Impact

ISO 14001

Paltan Smart Plant
Pyeongtaek Bio Plant

2023.09.29~2026.09.28
2023.12.07~2026.12.06

- Establishment and application of control manuals/procedures/
guidelines for water quality, air, waste, etc.
- Systems for reducing the use of direct energy resources such as
electricity and water,
Establishment of action plans for waste reduction and increased
recycling

Human Rights/Labor

Industrial Safety
Safety & Health

ISO 45001

Headquarters
R&D Center
Paltan Smart Plant
Pyeongtaek Bioplant

2024.10.29~2027.10.28
2024.10.29~2027.10.28
2024.09.23~2027.09.22
2023.12.07~2026.12.06

- Expanded investment in safety and health
- Activities to build a safety culture
- Evaluation of qualified contractors
- Safety and health education

Information Security

Internal Information
Personal
Information Leakage
Virus Hacking

ISO 27001

R&D Center
Paltan Smart Plant

2024.12.19~2027.12.18
2024.12.19~2027.12.18

- First ISO 27001 certification in the domestic pharmaceutical industry
in 2018
- Security training, anti-phishing email drills, newsletters
- Security manager workshops, group training

Fair Trade and Compliance Management

Unfair Customer
Inducement
Corruption

ISO 37001

Headquarters
R&D Center
Paltan Smart Plant
Pyeongtaek Bioplant

2024.11.29~2026.11.27
2024.11.29~2026.11.27
2024.11.29~2026.11.27
2024.11.29~2026.11.27

- First introduced in the domestic pharmaceutical industry in 2017
and validated through post-audits
- Continuous enhancement of anti-corruption and ethical management
awareness among executives and employees
- Expansion of corruption management scope to reduce risks of legal
violations

ISO 37301

Headquarters
R&D Center
Paltan Smart Plant
Pyeongtaek Bioplant

2024.11.29~2026.11.28
2024.11.29~2026.11.28
2024.11.29~2026.11.28
2024.11.29~2026.11.28

- First ISO 37301 acquisition in 2024
- Purpose of establishing a compliance management system aligned
with international standards

Disasters

Production
Suspension

ISO 22301

Headquarters
R&D Center
Paltan Smart Plant
Pyeongtaek Bioplant

2025.12.13~2028.12.12
2025.12.13~2028.12.12
2025.12.13~2028.12.12
2025.12.13~2028.12.12

- Identify the impact on business operations when risks occur through
BCMS
- Establish a system to ensure organizational resilience
ㆍ Prevent in-house mass infections and manage human resources
ㆍ Company-wide history management for employee/visitor health
checks
ㆍ Real-time response by emergency response organization

Quality

Medical Device
Quality
Management

ISO 13485

Pyeongtaek Bioplant

2026.01.21~2029.01.21

- First acquired ISO 13485 in 2011, maintaining certification through
regular external audits
- Fulfillment of customer requirements/external regulations