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Japanese Pharmaceutical Market & Registration Strategies- Part 2
Deepak Hegde
November 12, 2024
The second article in the series focuses on strategies for success in registering products on the Japanese market.
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Japanese Pharmaceutical Market & Registration Strategies – Part 1
Deepak Hegde
November 12, 2024
The article provides an outline of characteristics、Regulatory bodies、 Pricing、Reimbursement、the process of registering an innovative drug and generic drugs in Japan.
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South Africa Ups Registration of New Pharmaceutical Products
SHEM OIRERE
March 13, 2023
SAHPRA has recently announced completion of a review of 16,000 applications for new products and variations nearly four years after it took over from the former regulator, the Medicines Control Council.
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Electronic Drug Registration and Listing (eDRLS)
Lin Zhang
December 02, 2021
Last month (October 13, 2021), the Food and Drug Administration (FDA) held a conference that is part of the CDER Small Business & Industry Assistance (SBIA) Regulatory Education for Industry (REdI) series.
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InnoCare Announces First Subject Dosed in the Phase III Registrational Trial of TYK2 Inhibitor ICP-332 for the Treatment of Atopic Dermatitis in China
PharmaSources
November 15, 2024
InnoCare Announces First Subject Dosed in the Phase III Registrational Trial of TYK2 Inhibitor ICP-332 for the Treatment of Atopic Dermatitis in China
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Australia Therapeutic Goods Administration (TGA) Grants Provisional Registration for Novavax COVID-19 Vaccine
prnasia
January 20, 2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Australia's Therapeutic Goods Administration...
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CStone announced two key phase 3 registrational clinical trials of sugemalimab completed patient enrollment
prnasia
January 18, 2022
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines...
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CStone announces the clinical data from registrational study of Sugemalimab in stage III non-small cell lung cancer published in The Lancet Oncology
prnasia
January 17, 2022
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines...
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IND Application for Phase 3 Registration Study of KN046 in Combination with Chemotherapy for the Treatment of Pancreatic Cancer was Approved by CDE
prnasia
November 24, 2021
Alphamab Oncology (stock code: 9966.HK) announced that the IND application for phase 3 registration study (KN046-303) of the PD-L1/CTLA-4 bispecific antibody KN046 plus nab-paclitaxel/gemcitabine...
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Electronic Drug Registration and Listing Instructions
FDA
November 10, 2021
There are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates...