Tagged with regulation

MEA In the February edition of DIA’s Global Forum magazine Sybil Nana Ama Ossei-Agyeman-Yeboah of the West African Health Organization, Jane H. Mashingia from the East African Community Medicines Regulatory Harmonization Programme, and the Bill & Melinda Gates Foundation’s David Mukanga examine the state of joint assessment procedures in the East…

Singapore Writing in the December edition of DIA’s Global Forum magazine, Agnes Ho, Cindy Zen, and Tan Kwee Lan of Boehringer Ingelheim give an overview of the current regulatory framework for orphan drug registration in four ASEAN countries and what more could be done to improve it.   Regulatory authorities such…

Global The World Health Assembly Special Session on a Pandemic Treaty, which will convene health ministries from around the world in Geneva next week, offers a unique opportunity to take a look back and share some important lessons learnt from fighting the COVID-19 pandemic. James Anderson, Executive Director, Global Health, at…

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…