Browsing items tagged “regulation | EVERSANA”

Japan Pharma Association Introduces Bold Policy Measures to Reform Sector

Country: JAPAN | Region: ASIA & SOUTH PACIFIC | Type: Policy | Keywords: #covid19 #drugsupply #innovation #jpma #marketentryrewards #mhlw #patientaccess #pharmasector #r&d #re-pricing #regulation #taxincentives #vaccines PRICENTRIC BRIEF: The Japan Pharmaceutical Manufacturers Association (JPMA) has proposed a new policy for economic and fiscal management and reform in Japan, which was mainly inspired by the effect of the coronavirus pandemic on the healthcare system and pharmaceutical industry in Japan The proposal first addresses the immediate need of […]

Biosimilars Saved Spain 2,400 Million Euros Between 2009 and 2020

Country: SPAIN | Region: EUROPE | Type: Biosimilar | Keywords: #inflammatorydiseases #monoclonalantibodies #oncology #regulation #sefh PRICENTRIC BRIEF: The Spanish Society of Hospital Pharmacists (SEFH) calculated that Spain has saved more than 2,400 million euros between 2009 and 2020 through the introduction of biosimilars for the treatment of inflammatory diseases and cancer In the article, published in the May/June issue of the journal Farmacia Hospitalaria, Dr. Miguel Ángel Calleja, former […]

FDA Publishes Final Rule on New Regulatory Pathway Shift for Insulin, Other Biologics

Country: UNITED STATES | Region: NORTH AMERICA | Type: Policy | Keywords: #biologicdrugs #biosimilar #fda #insulin #regulation PRICENTRIC BRIEF: On March 23, 2020, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulin and other biological products, will be deemed to be a license for the product under the Public Health Service (PHS) Act For the first […]

South Korea Agrees to Numerous Arrangements with European Counterparts

Country: FRANCE, SOUTH KOREA, SWITZERLAND | Region: ASIA & SOUTH PACIFIC, EUROPE | Type: Regulation | Keywords: #ansm #drugapproval #europeandirectorate #gmpinspection #swissmedic PRICENTRIC BRIEF: The Ministry of Food and Drug Safety agreed to a joint trust arrangement for good manufacturing practice (GMP) with the Swiss Agency for Therapeutic Products, Swissmedic, a deal that will lessen the drug approval procedure for local biopharmaceutical firms by excusing them from Swiss GMP assessment Moreover, […]