Tagged with regulation

Mexico Writing in the November issue of DIA Global Forum, Lawrence Liberti, Mario Alanis, Pravin Chopra, and Silvia Bendiner examine how the COVID-19 pandemic facilitated greater inter-stakeholder collaboration across the healthcare ecosystems in Cuba and Mexico, and how the learnings from this period can be leveraged for better patient outcomes moving…

Japan Writing in the October edition of DIA’s Global Forum magazine, Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Yasuhiro Fujiwara outlines how his agency has begun to utilise real-world data (RWD) and real-world evidence (RWE) in its regulatory decision-making processes and how this will evolve moving forward.  …

Saudi Arabia Prof. Ahmed Aljedai, assistant deputy minister of therapeutic affairs for support services at Saudi Arabia’s Ministry of Health (MoH) outlines how the Saudi healthcare system is being restructured in line with the country’s Vision 2030 economic transformation programme and the three goals of improving access, improving quality, and improving value.…

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 Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval…

Denmark In a wide-ranging interview, incoming director general of the Danish Medicines Agency Lars Bo Nielsen discusses the challenges that personalised medicine presents to regulators, building a stronger international presence for the Agency, and better leveraging the country’s world-class data infrastructure while respecting the EU’s data protection regulation.   Within Europe,…

China In a comprehensive new piece, European Patent Attorney André Bourgouin and Adjunct Professor at CEIBS Eric Bouteiller examine the potential impact of China’s revision to its patent law on the country’s domestic biopharma innovation landscape and the ability of breakthrough drugs from MNCs to make it onto the Chinese market. …

Italy In recent months, a profound transformation has been occurring right at the core of the Italian pharmaceutical industry as the most significant reforms to market access within two decades start to take shape. While Mario Draghi’s energetic government has been dominating the headlines primarily for other reasons – namely sweeping…

Turkey TITCK is the regulatory agency in charge of ensuring the safety of medicines, health products, cosmetics, and personal care products in Turkey. Its recently appointed president, Dr Tolga Karakan, discusses the agency’s work with the WHO, ICH and EU Commission to help Turkish patients and consumers, their experience with emergency…

China Writing in the June edition of DIA’s Global Forum magazine, Harbour BioMed’s Fang Zhou, in conversation with Sanofi China’s Irene Deng, looks at how Chinese pharmaceutical regulations have evolved and what impact this has had on regulatory professionals in the country.   The Chinese pharmaceutical industry, through the first five…

Saudi Arabia In a recent conversation with PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA) outlined the organisation’s strategic priorities. As part of the Authority’s 2018-2022 strategic plan, it has set out a number of goals, ranging from setting clearer objectives to strengthening its capabilities,…

Saudi Arabia Speaking exclusively to PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA), outlines the SFDA’s key priorities under its current strategic plan. He also touches on why domestic pharma and medtech manufacturing is important to the SFDA, pricing issues for innovative new therapies, and…