Complying with Laws and Regulations and Upholding High Ethical Standards
Ensuring proper use
Astellas’ Medical Representatives (MRs) provide information on appropriate usage based on on-label information to healthcare professionals to ensure that Astellas pharmaceutical products are used safely and effectively. In promotion of Astellas products, MRs act with high ethical standards and strictly comply with the applicable laws and regulations, industry codes and company policies including Astellas Group Code of Conduct.
Medical Science Liaisons (MSLs) engage with healthcare professionals to exchange scientifically based information to advance their understanding and the safe and effective use of our products in patient care. MSLs also act with high ethical standards and provide reliable, clear, fair, balanced and unbiased medical and scientific information. MSLs refrain from promotion of products, and observe high ethical standards, making compliance their top priority.
Responding to inquiries
Astellas has a responsibility to provide truthful, balanced and unbiased medical information in response to inquiries regarding our products. By fulfilling this responsibility, Astellas supports the safe and effective use of our products.
In countries throughout the globe, we have Medical Information Call Centers that respond to a variety of inquiries. In our larger call centers, we have systems that allow for 24-hour responses to urgent inquiries, even on business holidays. In fiscal 2020, we responded to approximately 88,000 inquiries.
Astellas makes continuous efforts to improve its medical information services, with the aim of providing accurate, appropriate and consistent information. As part of these efforts, a global medical information system is used to receive inquiries for information and document medical responses from group companies around the world. This allows us to respond to inquiries in a simple, swift and accurate manner. At the same time, we can analyze feedback from patients and medical professionals and communicate these insights to support the life cycle management of our products.
We have recently implemented a new global medical information web portals for HCPs to allow for additional and direct access to information regarding our products.
Anti-counterfeiting activities
The infiltration of counterfeit/falsified medicines into the legitimate supply chain not only leads to the loss of opportunities for patients to receive effective medical treatment but could also pose severe adverse health consequences. This has become a serious problem worldwide.
Astellas has published a clearly defined Counterfeit/Falsified Medicines Position Statement*1 on our global website.
As an anti-counterfeit measure, Astellas commissioned a formal Committee comprised of leaders from multiple stakeholder functions (quality assurance, supply chain, etc.), and has also established a product security function to oversee daily activities relevant to product-related security risks. These entities monitor the global market for suspicious activities affecting Astellas products, and implement countermeasures targeting not only counterfeit/falsified medicines, but also diversion, theft and other illicit activities that potentially affect our products and/or present a potential risk to patients. Astellas systematically introduces anti-counterfeit measures, including, but not limited to, product serialization as stipulated by current regulations and pharmaceutical laws.
In addition, Astellas regularly engages in various collaborative activities with other members of the pharmaceutical industry to help prevent the spread of counterfeit/falsified medicines. We also proactively support and cooperate with national regulatory and judicial authorities in the prevention of counterfeit/falsified medicines.
*1 For details, please visit the following website:
Counterfeit/Falsified Medicines Position Statement
Product recalls
Astellas has a recall system in place that is activated when the safety, efficacy or quality of a product is brought into question. The system ensures relevant information is promptly passed on to medical institutions and other affected parties and that a recall of the product in question is instigated. Astellas voluntarily initiated 1 product recalls in fiscal 2020.
History of product recall
| FY | The number of recall | Severe (Class I) |
Moderate (Class II) |
Minor (Class III) |
Non Classified |
| 2014 | 3 | 0 | 1 | 1 | 1 |
| 2015 | 3 | 0 | 1 | 1 | 1 |
| 2016 | 3 | 0 | 2 | 1 | 0 |
| 2017 | 3 | 0 | 2 | 0 | 1 |
| 2018 | 7 | 0 | 4 | 2 | 1* |
| 2019 | 2 | 0 | 1 | 0 | 1 |
| 2020 | 1 | 0 | 0 | 1 | 0 |
* Authority-initiated recall
Improving the Pharmacovigilance (PV) System
Astellas is continuously improving its pharmacovigilance (PV) system by strengthening collaboration between its PV function and other relevant functions, affiliates and licensing partners. This is to respond to expansion of product strategies and advance the provision of trustworthy product information and proper product use, along with compliance with regulatory requirements.
Astellas has been building a system to collect product safety information from a variety of sources. The Company annually provides product safety awareness training not only to staff closely involved with the PV function but also to all employees and contractors including affiliate staff, to maintain and strengthen swift and appropriate collection of product safety information. For external service providers outsourced by functions other than the PV function, Astellas adds requirements for the collection of product safety information in their contracts as necessary.
Astellas has been maintaining safety databases and procedures used globally to respond to environmental change. In fiscal 2018, it completed a major upgrade of its safety database and procedures to meet regulatory requirement changes. In fiscal 2019 and 2020, it continued to enhance the safety database system to implement electronic submissions of safety reports in accordance with the regulatory requirements of each country.
Astellas is exploring utilizing real-world data such as large healthcare databases for evaluation of its product safety to help minimize risk by enhancing collaboration between PV and other functions. Furthermore, Astellas continues to explore automation technologies and artificial intelligence technologies that can be used for monitoring, intaking, processing and reporting of product safety information, and early identification and analysis of safety signals. We plan to use these technologies to strengthen our PV system.