Sustainability
Society
Bonds with Customers
Provide Value for Society, Using High Quality Pharmaceutical Products and Services Backed by Unique Technology
At the Hisamitsu Pharmaceutical Group, we help contribute to extending customers’ health spans by leveraging cooperation between the actors in our value chain, such as R&D, procurement, production, logistics, and sales/marketing/service. Our goal lies in delivering a better QOL to the world by supplying customers with high quality pharmaceutical products and services backed by our unique technology.
Value to Be Presented to Society
Since our establishment, we have been engaged in product development to satisfy customers’ needs in accordance with the basic policy of “The Customer-first Principle,” with our main focus on transdermal patches through which pharmaceuticals can be administered on a stable basis and which can be patched with comfort. In addition, we promptly reflect customer needs into our products and quickly respond to changes in the social environment, such as the aging population. To do so, we conduct product sampling to let customers and medical workers directly know about the excellence of our products, and also ensure cooperation between the actors in our value chain. While continuing to create value that will contribute to improving the environment and society, we will achieve global application of our technology developed in Japan so that we can present the world with new value that will contribute to citizens’ healthy and rich lives.
R&D
Based on the fundamental technology platform for TDDS that we have developed over many years, the R&D Division is working to develop TDDS formulations of drugs that are difficult to absorb through the skin. We are engaged in the research, development, and improvement of drugs that are clearly differentiated from existing and competing products by maximizing the benefits of TDDS formulations, such as stable efficacy and reduced adverse drug reactions resulting from sustained drug concentrations in the blood.
Additionally, in order to launch new pharmaceutical products in the global market as quickly as possible, we are striving to consolidate our R&D efforts made at our domestic R&D sites and our overseas subsidiary (Noven Pharmaceuticals, Inc.) and shorten the development pipeline period.
- Accumulated R&D know-how of TDDS products
- Ownership of the world’s No.1 brand
- Human resources with high-level expertise and experience
- Market growth due to "TE-A-TE" culture taking root worldwide
- Response to unmet medical needs
- Expansion through alliances with other companies
- Decrease in pharmaceutical prices due to the government’s medical cost reduction policy
- Change in the business environment due to intensifying competition with generic products
- Reinforcement and revision of pharmaceutical regulations in Japan and overseas
Drug Development
Hisamitsu Pharmaceutical Group is engaged in research and development of TDDS formulations (transdermal patches, gel, spray, and other topical formulations) to meet the fundamental needs of people around the world for “health, safety, and comfort” in their lives. By using TDDS formulations of drugs, we can respond to a wide range of medical needs regardless of the medical department, such as “maintaining appropriate drug blood levels for extended period,” “enabling drug administration to patients who have difficulty swallowing, such as children and the elderly,” and “allowing easy interruption of administration by removing or washing away the drug if adverse reactions develop.” In research and development, we are striving to develop highly useful TDDS formulations through exhaustive search for candidate drugs and active promotion of alliances. Furthermore, drugs are developed to meet the needs of healthcare community through the development of TDDS formulations that make full use of new fundamental technologies, such as microneedles for TDDS of a wider range of drugs, including polymeric drugs and vaccines.
R&D Pipeline
Click here for information on our R&D pipeline.
Expansion of Target Diseases for Hisamitsu TDDS
Microneedle Technology
HalDiscⓇ Technology
(Pinhold-shaped microneedle technology)
Realization of macromolecular drugs that are treated as injectable drugs such as vaccines, offering easy self-medication by anyone
SheetifyⓇ Technology
(Sheet-type microneedle technology)
Hisamitsu's proprietary sheet-type device for the realization of high-dose transdermal administration
HalDisc beauteⓇ
(Cosmetic Microneedle Technology)
Hybrid technology for cosmetic use that combines transdermal absorption technology and microspike substrates to create a pleasant stimulation sensation
Drug Improvement
In the improvement of drugs, we have continuously worked to choose the size and shape fit for the purpose and reduce the frequency of use of drug products in order to improve quality of life of our customers, mainly based on customer opinions (needs), the latest manufacturing technologies, and our research and development outcomes.
Until now, the focus has been on the perspectives of manufacturers and users, but it is important to proactively consider new perspectives as the Hisamitsu Pharmaceutical Group works to promote ESG and the SDGs. We will continue to consider the environmental impact of our products and actively work to improve them into ECO products with the purpose of reducing CO₂ emissions. In addition, the “standardization of product specifications” is being promoted as one of our measures to reduce environmental impact through a joint project among R&D, Production, and Sales divisions. Furthermore, from the perspective of open innovation, collaboration is promoted with suppliers, utilizing a broad range of technology information.
Ethical Drug Development
Ethical and Scientific Clinical Studies
To ensure human rights and safety of patients participating in clinical studies, clinical trial protocols are prepared in compliance with the Pharmaceutical Affairs Law and the GCP*1 while obtaining informed consent from the patients. Additionally, the Internal Institutional Review Board is established to assess the ethical and scientific validity of studies with outside medical experts as members. When conducting clinical studies outside Japan, we observe the ICH-GCP*2 and comply with the regulatory requirements and guidelines of each country.
*1 GCP:Good Clinical Practice Standards for practice of clinical studies of drugs.
*2 ICH-GCP:International GCP Guidelines on the practice of clinical trials and clinical studies agreed at the Japan, the U.S. and EU ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
Ethical Accommodation for Animal Welfare
Hisamitsu Pharmaceutical has formulated the Animal Testing Guiding Principle in line with the Act on Welfare and Management of Animals to ensure that respect for animal welfare is completely shared and that animal testing is performed properly with accommodation for animal welfare. For animal testing to inspect drug efficacy and safety, we have a system requiring all such testing to be reviewed by the Animal Testing Committee, and research is conducted under the 3R Principles: Replacement, Reduction, and Refinement.
In addition to conducting regular self-inspection, our animal testing operations underwent third-party review and are accredited as an animal testing facility. We intend to ensure further appropriateness of animal testing and maintain and improve animal welfare.
Procurement
At our procurement departments, not only do we strive to maintain a stable procurement of quality raw materials, reduce costs, and ensure that delivery deadlines are strictly met (and cope with natural disasters), but we also improve our supply chain, collect information from suppliers, and share such information with other in-house departments. From the phases of product planning and research, our procurement departments engage in discussions on raw materials in cooperation with related departments in order to establish a stable supply structure. At the same time, we strive to promptly reflect customer needs in our product development.
Based on our global strategies, we select appropriate raw materials so that people in many countries can use our products without worry, for example, in terms of human rights risks in our supply chain and conformity with Halal standards. We also procure items in light of their environmental friendliness, such as their contribution to reducing resource use, reducing waste generation, and increasing the use of recovered paper.
In December 2021, in response to the growing importance of sustainable procurement, the Company established the “Sustainability Procurement Basic Policy,” and the “Sustainability Procurement Standards for Suppliers,” which suppliers are required to understand and comply with, as the “Sustainability Procurement Guidelines.”
Sustainable Procurement Guidelines
- Firm relationships of trust with business partners established over our long history
- Conducting discussions on stable supply from the research stage
- Cross-sectional communication to promptly respond to customer needs
- Enhancement of our competitive edge by ensuring further transparency in the procurement of raw materials
- Stable supply of environmentally friendly raw materials
- Enhancement of our reputation through appropriate responses
- Reinforcement of our management foundation by ensuring greater transparency
- Impact from fluctuations in the cost of raw materials, packaging materials, etc. as well as exchange rates
- Dependence on external sources for the procurement of raw materials
- Malfunction in the procurement of raw materials due to climate change
- Changes in supply chain environment and the emergence of human rights related risks
Declaration of Partnership Building
This time, we announced the “Declaration of Partnership Building” on July 26th, 2023, in agreement with the aims of the “Council for the Building Partnerships to Lead the Future”, which is promoted by the Cabinet Office and The Small and Medium Enterprise Agency. We aim to build new partnerships by promoting cooperation and mutual prosperity with our suppliers in the supply chain and with businesses that create value.
Production
While ensuring cooperation with manufacturing contractors, our domestic production is centered on the Tosu Factory (Saga Prefecture) and the Utsunomiya Factory (Tochigi Prefecture), both of which are in compliance with the GMP(*), so as to maintain a stable supply of products.
In addition to ensuring a stable supply, we are also working to improve productivity. We are raising the efficiency of the entire production process not only by carrying out KAIZEN (improvement) activities on continual basis , but by reviewing the production system through consolidation and elimination of production lines, improving individual processes, and increasing operating rates.
Moreover, we have introduced an IoT-based production system, thereby promoting KAIZEN activities using big data accumulated in the production system and further improve productivity.
We globally sell pharmaceutical products, many of which are directly exported from Japan. To establish an even more stable supply system, however, we also have production sites in the U.S., Brazil, Vietnam, and Indonesia. While ensuring cooperation between our domestic and overseas production sites, we are localizing production and expanding our production capacity so that we can reinforce our global production system.
*GMP:Good Manufacturing Practice
- Production technology developed over our long history
- Environmentally friendly product design
- Technology to realize product improvement from the perspective of customers
- Environmentally friendly production efforts
- Technology-based upgrade of production facilities
- Establishment of a global production system
- Soaring logistics, labor, and raw materials costs
- Impact of large-scale disasters on production facilities
- Emergence of product accidents with impact on customers
- Emergence of problems related to the environment or human rights in the supply chain
Logistics
We have logistics centers in eastern Japan (Kuki City, Saitama Prefecture) and in western Japan (Tosu City, Saga Prefecture), which underpin our logistics structure to maintain a stable supply of our products. We ensure that the pharmaceutical products manufactured by our contractors also pass through these logistics centers as part of our supply chain.
Staffed by supervising pharmacists to manage the quality of our products, each center shares information on its shipment volume together with relevant factories. This enables a wide variety of pharmaceutical products to be stored and managed properly and to be supplied to customers on a stable basis. For employees involved in the management of this system, we implement manual-based training in order to reduce human error and ensure a stable logistics structure.
Although many of our products are transported by land, we are making a modal shift in the main transportation arteries for the shipping of large-volume items from road transport (trucks) to sea transport, which has less impact on the environment. While expanding this modal shift on a continual basis, we will increase our loading efficiency and leverage a joint delivery system, and thereby strive to raise our transportation efficiency.
- Logistics structure underpinned by the two bases in the east and the west to ensure a stable supply
- Increase in transportation efficiency through modal shift and joint delivery to reduce environmental impact
- Training programs for employees involved in the management system
- Higher efficiency and cost reduction by using technology
- Prompt and well-tuned response backed by the logistics network
- Innovation of the conventional business model through logistics reform
- Enhancement of our reputation through environmentally friendly efforts
- Appreciation in logistics costs and labor costs
- Product price fluctuations and excessive inventory
- Impact of large-scale disasters on our supply chain
- Emergence of problems due to tightening of laws and regulations
- Emergence of problems related to the environment or human rights in the supply chain
Sales/Marketing/Service
At sales/marketing/service, we provide and collect information on the effectiveness and safety of our products to enable medical workers and patients to use them with peace of mind and also to ensure appropriate use of the products. Additionally, requests from healthcare professionals collected by MRs are shared with related departments to further improve products, and the OTC business also promotes “Jissen” in which samples are distributed to directly communicate the superiority of products to consumers.
We help not only patients in the medical field, but also other people around the world maintain and improve their good health.
- High level of recognition and dissemination to medical professionals through "Jissen," distribution of sample to consumers
- Prompt reflection of customer needs in product improvement
- High-quality products that take into consideration the use process and even more pleasant feel of use
- Increased awareness of good health worldwide
- Increase in the number of those suffering from disorders due to changes in their lifestyles
- Increase in demand for patch products in response to medication adherence
- Impact on profits due to reduction in medical expenses and pharmaceutical prices
- Change in the business environment due to intensifying competition with generic products
- Reduced medical examinations and slow penetration of new products in the with COVID-19 era
Quality Assurance
Quality is assured through GMP-compliant and scientifically established methods of production to ensure the reliability and safety of drugs.
Our quality assurance operations range extensively from “preparing process charts related to production and quality,” to “inspecting, testing and evaluating products,” “analyzing defect trends,” “auditing and instructing business partners,” and “correspondence with customers after shipment.” Furthermore, we carry out a wide range of internal and external quality assurance, including the creation of a smooth transition from the formulation development stage to the production stage to ensure quality assurance structure and management and auditing of the production system of contractors that manufacture OEM (*) products.
We have established an internal compliance promotion organization to monitor compliance with strict laws and ordinances and voluntary regulations. Additionally, we are constantly striving to improve quality and safety of our drugs under the strict quality control system, including inspections of our quality system by public agencies.
*OEM: Original Equipment Manufacturer
- Integrated quality assurance framework from research and development to manufacturing and marketing
- Production of high-quality pharmaceutical products with scientifically established, GMP-compliant methods
- Quality audit framework designed for Japan and overseas suppliers
- Safety management structure enabling prompt, appropriate, cross-sectional responses
- Expansion of quality assurance and safety control frameworks to global bases
- Improvement of quality reflecting customer requests
- Reinforcement of our management foundation by ensuring greater transparency
- Enhancement of our reputation through appropriate responses
- Response to the tightening and revision of laws and regulations in Japan and abroad
- Emergence of product accidents with impact on customers
- Emergence of quality problems in the supply chain
Commitment to Product Reliability Assurance
Since pharmaceuticals are life-related products, strict management standards are established to ensure their reliability, including GLP*1 and GCP*2 at the research and development stage, GMP*3 at the manufacturing stage, and GPSP*4 and GVP*5 at the post-marketing stage. Our Quality Assurance & Pharmacovigilance Division conducts rigorous audits focusing on control standards at each stage of product development, ultimately ensuring product reliability through a system of reliability assurance covering the entire product lifecycle. Furthermore, in line with the globalization of the Company, we are working to strengthen our auditing system by expanding the scope of risk assessment as well as complying with the latest regulations and guidelines in each country.
*1 GLP:Good Laboratory Practice Standards for practice of nonclinical studies for the safety of drugs.
*2 GCP:Good Clinical Practice Standards for practice of clinical studies of drugs.
*3 GMP:Good Manufacturing Practice Standards for production management and quality control of drugs and quasi-drugs.
*4 GPSP:Good Post-marketing Study Practice Standards for post-marketing research and practice of study on drugs.
*5 GVP:Good Vigilance Practice Standards for post-marketing safety management of drugs, quasi-drugs, cosmetics, medical devices and regenerative medicine.
Supplier Audits
We conduct on-site or written surveys of approximately 70 raw material suppliers in Japan and abroad each year to confirm that the manufacturing and quality control of raw materials is being carried out appropriately. Audit items are set mainly on important matters related to the operations of drug substance and raw material manufacturing facilities, formulation manufacturing facilities, testing facilities, and other facilities based on the GMP and other standards.
We also conduct a special audit in the event of quality-related changes or complaints. We also perform similar audits of our production and operation contractors and service suppliers in order to ensure product quality and stable supply.
Inquiries from Customers
At Hisamitsu Pharmaceutical, we have the Customer Center as a contact point for customers to make inquiries about our products. We respond to not only inquiries through our website, but also inquiries from individual customers by phone and letter.
While striving to make attentive, prompt, and appropriate responses to such inquiries, we share feedback and indications from customers internally among related departments in order to help improve the relevant products or develop new products.
