This General Personal Information Protection Policy for Pharmacovigilance, Medical Information, and Product Quality Complaints ("Protection Policy") applies to:

●  Individuals reporting adverse events/special situations, providing safety information concerning our products, initiating medical information inquiries, and submitting product quality complaints; 

●  Individuals involved in adverse events/special situations, medical information inquiries, and product quality complaints.

Sumitomo Pharma strives to protect personal information and adheres to transparent principles for collecting and using personal information. This Protection Policy outlines how Sumitomo Pharma Co., Ltd., Sumitomo Pharma America, Inc., as marketing authorization holders, and their affiliates (including Sumitomo Pharma (China) Co., Ltd., Sumitomo Pharma (Suzhou) Co., Ltd., and Sumitomo Pharma Trading (Suzhou) Co., Ltd. in China (hereinafter referred to as "Sumitomo Pharma" or "we"), as personal information processors, handle your personal information.

We encourage you to carefully read this Protection Policy, as the protection of personal information of reporters/inquirers/complainants and patients (hereinafter referred to as "you") is extremely important. If you are not the patient, you should ensure that you have informed the patients of the contents of this Protection Policy and obtained the necessary and appropriate consent or authorization from them before providing us with the patients' personal information.

For any additional queries, please contact privacy.support@sumitomo-pharma.com.cn.

Why do we collect and use personal information?

Our purposes for processing personal information are set out below. We will not process personal information without appropriate legal basis.

What personal information do we collect and use?

For the purposes stated in this Protection Policy, we gather and utilize the following types of personal information:

●  Information pertaining to individuals who report adverse events or special scenarios (drug exposure during pregnancy and lactation, overdose, off-label usage, ineffectiveness, etc.) or pose inquiries about medical information or lodge complaints about product quality, including medical personnel and caregivers. This enables us to respond to inquiries and seek further information as required. The personal information we collect may include your name, email, personal contact number, address, and fax number. If you're medical personnel, we might also authenticate your status by collecting personal information (feedback codes from your affiliated medical facility, workplace, department, profession, and position);

●  Patients' detailed information, including their name (abbreviated with the initial letters of Pinyin), age or birth date, gender, ethnicity, nationality, weight, height;

●  Information on patients' health and lifestyle, including but not limited to the characteristics of adverse events, descriptions of adverse events (commencement and conclusion timings, outcomes, gravity), clinical records, lab reports, past health issues, diseases or associated occurrences, risk factors, medication history (past drug usage, combined drug usage, suspected drug usage, therapeutic medications, frequency of drug administration, dosage, indications, drug titles, methods of administration, commencement and conclusion timings, etc.), bodily exercises, dietary intake and eating patterns, sexual activity/contraception, and smoking, drinking, and substance abuse (provided that gathering such personal information is absolutely crucial and beneficial for fulfilling the objectives outlined in this Protection Policy).

The bold personal information above represents your sensitive personal information. We solely handle your sensitive personal information when we possess a distinct objective and ample necessity, and we implement rigorous safeguarding measures. These handling activities are anticipated to have no detrimental impact on your rights and interests.

How do we entrust the processing and sharing of personal information?

We will not provide personal information to third parties or otherwise transmit personal information, except to the personnel/companies specified in this Protection Policy:

Entrusted Processing. We may entrust our affiliates and other service providers acting on behalf of Sumitomo Pharma Co., Ltd. to carry out related activities (such as IT system and data hosting providers, as well as adverse event collection and processing service providers (including call center providers)) to process your personal information for us. In accordance with applicable data protection laws, these third parties are contractually bound to protect the confidentiality and security of personal information.

Sharing. Additionally, we may share personal information with the following individuals/organizations:

●  Medical personnel involved in adverse events, information requests, or complaints;

●  Affiliates within the Sumitomo Pharma Group. For a complete list, please visit: https://www.sumitomo-pharma.com/profile/office/;

●  Regulatory bodies, including the National Medical Products Administration (NMPA) of China (https://www.nmpa.gov.cn/), the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the European Medicines Agency (EMA) (https://www.ema.europa.eu) which manages the EU EudraVigilance database, and the U.S. Food and Drug Administration (FDA);

●  National and/or international regulatory authorities, law enforcement agencies, public institutions, or courts, if required by applicable data protection laws or regulations, or upon request from the relevant authorities.

Where is personal information stored?

To achieve the processing objectives set out in this Protection Policy, we may share the personal information we have collected about you through various channels in China (including emails, hotlines, public documents, follow-ups, regulatory sharing, etc.), which encompasses adverse event reporting information, with our affiliates outside China (including Sumitomo Pharma Co., Ltd. and Sumitomo Pharma America, Inc.), and process and store your personal information outside China. Regarding the cross-border transfer of personal information, if you wish to exercise your rights pertaining to personal information or contact the overseas recipient, you can do so via the contact details provided in the "How to contact us" or "How do we transfer your personal information from China to overseas" sections of this Protection Policy.

How do we transfer your personal information from China to overseas?

As Sumitomo Pharma is a multinational corporation, we may utilize the company's application systems located outside China for personal information processing to meet the global business operation and management requirements of Sumitomo Pharma. To fulfill the processing purposes stated in the "Why do we collect and use personal information" section of this Protection Policy, and in adherence to applicable laws and regulations, the personal information we gather or that you furnish to us (for patients, this includes patient ID/ abbreviation of initials, date of birth, ethnicity, gender, nationality, test reports, medical history, medication records, and descriptions of adverse events; for reporters/consultants/complainants, this includes name, occupation, feedback code of the affiliated medical institution, nationality, personal phone number, email, fax number, and address) will be transmitted to our overseas affiliates (names of overseas affiliates: ① Sumitomo Pharma Co., Ltd., contact information and right exercise channels: +81-3-5205-3728.  For further details on processing methods, please refer to its protection policy: https://www.sumitomo-pharma.com/privacy; and ② Sumitomo Pharma America, Inc., contact information and right exercise channels: +1-877-394-7377 (press #5). For further details on processing methods, please refer to its protection policy: https://www.us.sumitomo-pharma.com/privacy-notice/).

How long do we keep personal information?

We will employ commercially reasonable steps to safeguard your personal information, factoring in: (1) the level of technological advancement, (2) implementation costs, (3) the characteristics of personal information, and (4) the hazards linked to personal information handling. The objective is to shield personal information from accidental or unlawful destruction, alteration, loss, unauthorized disclosure or access, and other illegal activities. Moreover, we will retain the aforementioned personal information only for the duration we reasonably believe is necessary to fulfill the purposes stated in this Protection Policy as required by applicable data protection regulations.

How do we manage information of minors?

If you're a minor below 14 years old, please request your parents or guardians to peruse this policy and only supply us with your information after securing their consent. If your guardian disagrees with providing us information based on this Policy, please refrain from doing so; if already submitted, please inform us promptly so that we can undertake suitable actions.

When furnishing us with information of minors as a guardian, please also peruse this Policy. For any inquiries about information handling, please reach out to us using the contact details in the upcoming "How to contact us" section.

In cases where we gather personal information of minors with guardian's consent, we will only use, share, transfer, or disclose such information when sanctioned by law, with the guardian's consent, or as necessary to protect the minors.

What are your rights and how can you exercise them?

You have the right to:

●  Be informed about and determine how we process your personal information, or restrict or refuse our processing of your personal information;

●  Access your personal information and request corrections or updates if you believe it is incorrect, outdated, or incomplete;

●  Obtain a copy of your personal information;

●  Request the deletion of your personal information under specific circumstances;

●  Withdraw your consent at any time, if the processing of personal information is based on your consent, without affecting the legitimacy of the processing that occurred prior to the withdrawal;

●  Request explanations regarding our personal information processing rules; 

●  Request that we transfer your personal information to another specified personal information processor.

Please note that we may be unable to respond to your request to exercise your rights due to requirements under applicable data protection laws.

If you have any questions or wish to exercise the aforementioned rights, please visit: https://www.sumitomo-pharma.com.cn/privacy.

In any case, in addition to the rights mentioned above, you also have the right to lodge a complaint with the regulatory authorities.

How to contact us?

If you have any questions or concerns about how we process your personal information and this Personal Information Protection Policy, especially if you consider that our processing of your personal information impairs your legitimate interests, please contact us by sending email to privacy.support@sumitomo-pharma.com.cn. We will review your problem without delay and make a timely reply according to the applicable laws and regulations.

Last updated in July 2024