In order to understand if there is other unknown side effect during the clinical trail, the PMS (Post-Marketing Study) will be conducted to learn more treatment experiences on patients, and collect their information for further study.
No. 9 of IRPMA COP Benchmarks regulates that all PMS shall go through JIRB, IRB or Ethics Committee and must be registered on the website of IRPMA PMS registry system. It is to ensure the studies conducted on patients have been approved by JIRB, IRB and protect patient’s right of privacy. The public can also get the information and objective of the PMS through the registry system.
Title of Study
Observational study of atopic dermatitis patients treated with dupilumab in Taiwan 2023-08-24
An Observational Study of Enzyme Replacement Therapy-Naïve and Agalsidase beta-Treated Fabry Disease Patients with GLA IVS4+919 G>A Mutation in Taiwan 2023-08-24
A Post-Authorization, Multicenter, Multinational, Longitudinal, Observational Safety Registry Study for Patients Treated with Voretigene Neparvovec 2023-08-24
ON-TRK: PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with Larotrectinib / ON-TRK 2023-08-24
Pfizer Ltd. Taiwan
LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES 2023-08-24
Daiichi Sankyo Taiwan Ltd.
A retrospective, non-interventional, multicenter study to estimate the prevalence of HER2-low and describe the standard-of-care, treatment patterns and outcome in real-world practice among unresectable and/or metastatic breast cancer patients with HER2-low status in Taiwan – the RetroBC-HER2L-TW Study. 2023-08-24
Bayer Taiwan Co., Ltd.
AURIGA/An observational study program to investigate the effectiveness of intravitreal Aflibercept in diabetic macular edema and/or macular edema secondary to retinal vein occlusion in a real world setting. 2023-08-24
Novartis (Taiwan) Co., Ltd.
Evaluating the Safety of Myfortic (Mycophenolate sodium) in patients with Lupus Nephritis: a 12 Month, Single-arm, Observational Study in Taiwan population 2023-08-24
Janssen, Jahnson & Johnson
Multicenter observational drug registry of Opsumit® (macitentan) in connective tissue disease associated pulmonary arterial hypertension (CTD-PAH) in real world Taiwan clinical setting 2023-08-24
Bayer Taiwan Co., Ltd
Systemic treatment patterns of hepatocellular carcinoma (HCC) in Taiwan 2023-08-24
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