China The following is an overview from Accestra Consulting* of Part 2 of China’s Center for Drug Evaluation (CDE)’s 2020 reporting, including an overview of administrative drug approvals and fast track review pathways by CDE. Abstract Despite severe challenges from the COVID-19 pandemic, the Center for Drug Evaluation (CDE) of…
USA PhRMA’s Lori Reilly warns that, as US policymakers seek to reduce drug prices, they must avoid policies that reduce access and choice. America is the centre of cutting-edge biopharmaceutical innovation. Not only are many of the latest treatments and cures developed in labs by researchers across the United States,…
Global Paula Barbosa, head of influenza policy and advocacy at the IFPMA and board member of the #TogetherAgainstFlu campaign, looks ahead to what could be a devastating 2021/22 flu season, with natural immunity among vulnerable populations down following the pandemic induced lockdowns and preventive measures of last year. Barbosa lays out…
Norway Norway has been a global frontrunner in collecting health data and building unique registries for decades but has struggled to utilise and benefit from them. Karita Bekkemellem, CEO of the Association of the Pharmaceutical Industry in Norway (LMI), examines how a new health data sharing platform can change that— to…
APAC Writing in the September edition of DIA’s Global Forum magazine, Rosilawati Ahmad of Malaysia’s National Pharmaceutical Regulatory Agency; Tharnkamol Chanprapaph of the Thai FDA; and Samvel Azatyan, Valerio Reggi, and Prapassorn Thanaphollert of the World Health Organization highlight the progress towards regulatory harmonization in ASEAN and work between country-level regulatory…
Canada Writing in the September edition of DIA’s Global Forum magazine, Dr Judith Glennie examines the specific steps that have been taken in the journey towards a National Pharmacare program in Canada, including the creation of a Canadian Drug Agency, a National Strategy for High-Cost Drugs for Rare Diseases, and an…
Sweden Anders Blanck, CEO of Lif, the trade association for the research-based Swedish pharmaceutical industry, writes about the challenges the world faces from antimicrobial resistance (AMR). Sweden has for decades been a pioneer in the field, and Blanck believes that Sweden is an excellent test market for various incentive models that,…
China Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), picks out the key learnings from recent legislation to improve China’s drug regulatory capacity and why it potentially marks a new era for the country’s innovative pharma industry. On April 27, 2021, the General Office of…
Global Bill Sibold, Executive Vice President and Head of Sanofi Genzyme, highlights the achievements of the company’s Rare Humanitarian Program over the last 30 years, bringing treatments to patients in developing countries with lysomal storage disorders who would otherwise not have access. Sibold outlines the persistent obstacles facing people with rare…
USA John M. O’Brien, recently appointed president and CEO of the US National Pharmaceutical Council, calls for innovation in benefit design reform to match the unparalleled speed and ingenuity with which the biopharmaceutical industry developed vaccines and therapeutics to combat the COVID-19 pandemic. The biopharmaceutical industry developed COVID-19 vaccines and…
China The following is an overview from Accestra Consulting* of Part 1 of China’s Center for Drug Evaluation (CDE)’s 2020 reporting, including data on drug approvals for all application types (including Investigational New Drugs (INDs), New Drug Applications (NDAs), and ANDAs), hot topics within new drug approvals for 2020, and reasons…
Japan Writing in the August edition of DIA’s Global Forum, Kotone Matsuyama of the Nippon Medical School gives a run-through of Japan’s response to the COVID-19 pandemic, from the organisation and communication of the country’s public health apparatus to the rollout of treatments and vaccines and the growing use of remote auditing…
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