DIA

Drug Information Association (DIA)

DIA is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow.

https://www.diaglobal.org/

DIA is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow.

https://www.diaglobal.org/

Articles: DIA

Collaborative Efforts and Regulatory Harmonization: Progress and Challenges in Latin America

LatAm / For the second consecutive year, DIA Europe hosted a Latin America Town Hall, a panel discussion to foster collaboration and share updates from regulatory activities in Latin America and Europe, and the intersections between them. MSD’s Leonardo Semprun, writing in the May 2024 edition of DIA’s Global Forum magazine, highlights his key takeaways.   Representatives…

Bridging the Open Innovation Gap Between Academia and Pharma in Japan

Japan / Writing in DIA’s Global Forum magazine for April 2024 on behalf of DIA Japan’s Open Innovation Community Fumitaka Noji, Takeshi Kono, and Makoto Nagaoka look at how the gap between Japan’s academia and pharma companies can best be bridged to fully reap the benefits of innovation.   Although open innovation in drug research and development has long…

New Drug Approvals in China Reach Record High in 2023

China / In 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year, write Chunrong Yu of Gracell Biotechnologies and Xu Wang of Novo Nordisk (China) Pharmaceuticals in the April 2024 edition of DIA’s…

Defining Gene Therapy Medicinal Products in the EU: Scientific & Regulatory Perspectives

Opinion / Writing in the March 2024 edition of the DIA Global Forum magazine, experts from Moderna, Cencora PharmaLex, CureVac, and BioNTech review the scientific potential and regulatory challenges, such as the lack of global harmonization, surrounding gene therapy-based medicinal products. Gene therapy medicinal products (GTMPs), which in the European Union (EU) are a subset of advanced…

Animal-Derived Ingredients in Medicines: A Call to Action

Opinion / Writing in the March 2024 edition of the DIA Global Forum magazine, Scott P. Commins of the University of North Carolina School of Medicine, Jasmine Uchi of VeganMed, and Sachin A. Shah of the University of the Pacific address the use of animal-derived ingredients (ADIs) in pharma and outline a call for regulatory action to…

US Drug Pricing and Reimbursement: Players, Payers, PBMs, and Prospects

USA / In late 2023, The Wall Street Journal published the article Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them. This article examined interactions between patient health insurance prescription benefits, pharmacies, and pharmacy benefit managers (PBMs), and their collective impact on the prices that patients pay for their prescription drugs in the United States.…

Drug Shortages in the Global South: A Proposed Parallel Tech and Reg Transfer Framework

Africa / Writing in the February 2024 edition of the DIA Global Forum magazine, Verena Pfaffinger and Ilona Baraniak-Lang of PharmaLex examine how the drug shortages seen in the global south during and after the COVID-19 pandemic can best be overcome through the adoption of decentralised manufacturing.   The COVID-19 pandemic exposed significant challenges in the pharmaceutical…

Rare Disease Moonshot: Europe’s Public-Private Coalition to Erase the Rare Disease “White Spots”

Europe / A new piece in the January 2023 edition of DIA’s Global Forum magazine lays out how a new coalition aims to transform the landscape for rare disease treatments in Europe and beyond.   The knowledge and infrastructure required to unlock rare disease “white spots,” diseases where there is currently no science or translational capability, call…

Japanese Academic Clinical Data Can Now Be Used for Drug Registration

Japan / Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised.   Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems fragmented. IITs are categorized as…

The Evolution of US FDA Diversity Requirements in Clinical Research

USA / The US Food and Drug Administration has increasingly recognized the importance of diversity and representation in clinical trials over the past few decades. This evolution reflects growing awareness across medicine that differences in age, gender, race, and ethnicity can impact disease risk, treatment response, and health outcomes. Darshan Kulkarni of Kulkarni Law Firm, writing in…

3 Essential Characteristics for AI Impact in Clinical Research

Global / AI is the buzzword du jour across all industries, but what is needed for it to truly make a difference in clinical trials? Writing in December 2023’s DIA Global Forum magazine, Lokavant’s Rohit Nambisan lays out the three essential characteristics for AI impact in clinical research, foregrounding the vital importance of providing a measurable return…

New FDA Guidance Addresses Challenges with Cell and Gene Manufacturing Comparability and Complexity

USA / Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT) products is often challenged by…

EU Acts on the Promise of Artificial Intelligence for Medicinal Products

Europe / Pfizer’s David Isom and Monica Mihedji, writing in the November 2023 edition of the DIA’s Global Forum magazine, examine how the European Medicines Agency is attempting to integrate the use of artificial intelligence in its regulatory work.   Regulators are advancing information technology and data modernization initiatives to drive more efficiencies and to become more…

HTA: Australia’s Independent Review, New Zealand’s New Collaboration

Australia / Richard Day of the University of New South Wales, writing in the October 2023 edition of DIA’s Global Forum magazine, looks at updates to the health technology assessment (HTA) processes in Australia and New Zealand   In April 2023, the Australian Department of Health and Aged Care launched an independent Health Technology Assessment (HTA) Policy and…

Ensuring Quality in Real-World Data in Japan

Japan / Real-world data (RWD) offers the possibility of providing important information to help inform regulatory decision-making. But turning this possibility into reality still depends on the quality and reliability of the data, say J&J’s Yumi Wakabayashi and Vicky Han in October 2023’s DIA Global Forum magazine. With appropriate efforts to ensure data quality, RWD can support…

Brazil’s ANVISA On the Way to Becoming a Global Reference Agency

Brazil / The DIA Global Annual Meeting 2023 hosted DIA’s first regulatory Town Hall fully dedicated to one regulator from Latin America, as leadership from Brazil’s Health Regulatory Agency, ANVISA, shared updates on the country’s regulatory priorities, the agency’s strategic priorities, and local trends, as well as ongoing regulatory convergence and collaboration initiatives. This article, first published in the…

Expanding Patient Engagement and Patient Centricity in Clinical Trials in China

China / Writing in the September 2023 edition of DIA’s Global Forum magazine, Shuting Li of Anhui Jimin Cancer Hospital and Xinfang Fan of Bayer Health Care Ltd. examine how Chinese clinical trials are increasingly focusing on patient engagement and patient centricity.   In recent years, with the Chinese government’s vigorous support and all-round promotion for innovative…

Advancing Biopharmaceutical Innovation and Patient Access: Call to Action for Latin American Regulators

Americas / Writing in the August edition of DIA’s Global Forum magazine, Silvia B. Bendiner of WESSX Inc. and Belkis Romeu call for greater regulatory collaboration between Latin American countries, building on an initiative created by Dr. Rafael Pérez Cristiá at the Cuban Regulatory Authority (CECMED).   The need for further regulatory convergence and collaboration among regulators…

Implementation of China’s Marketing Authorization Holder System: Opportunities and Challenges

China / Writing in the August edition of DIA’s Global Forum magazine, Wen Yin of the Pfizer China R&D Center and Wanhe Deng of GSK China Investment look back on four years of China’s marketing authorization holder (MAH)-based regulatory system, including the opportunities it presents, and some of the implementation challenges.   After a four-year pilot program…

The African Medicines Agency and the Evolution of Continental Regulatory Systems

Africa / Writing in the July 2023 edition of DIA’s Global Forum magazine, Nevena Miletic of Roche and the IFPMA’s Africa Regulatory Network and Ian Hudson from the Bill and Melinda Gates Foundation look back on the progress made towards instituting an African Medicines Agency and the next steps in this important process.   From 22-24 March,…

Achieving Greater Competitiveness for Clinical Trials in Latin America

LatAm / Writing in the July 2023 edition of DIA’s Global Forum magazine, Mariana Abdala of Crystal Research outlines the vast room for improvement in Latin America’s clinical trial output, the region’s fundamentals as a research hotspot, and the strategies in place to bolster its global positioning.   Clinical trials in Latin America still face many challenges:…

Regulatory Reliance: Practical Solutions for Patients

Europe / Writing in the June 2023 edition of DIA’s Global Forum magazine, Angelika Joos of MSD and Susanne Ausborn Roche consider some of the key takeaways from a workshop on regulatory reliance at DIA Europe 2023 which brought together international representatives from both industry and regulatory bodies.   Reliance* is considered the hallmark of a modern, efficient…

Addressing Cancer Health Disparities in Latinos via Clinical Trials

USA / Although clinical trial diversity remains high on the agendas of industry sponsors, there is still a long road to travel towards more equitable and representative research – and ultimately safer and more effective medicines. On this theme, writing in the June 2023 edition of the DIA Global Forum magazine, Jorge Gomez of the Center for…

Healthy Societies Need Healthy Women; The Importance of Equitable Clinical Research

USA / Sanskriti Thakur of decentralised clinical trial platform provider Medable, writing in the May 2023 edition of DIA’s Global Forum magazine, argues for an urgent rethink of clinical research to better include a more diverse patient population and protect women, mothers, families, and society at large.   This Mother’s Day, women across the US and in…

Improving Vaccine Access in Asia Pacific: A Call to Action

APAC / As the COVID-19 pandemic showed, vaccination is perhaps the most important tool a country has in maintaining the health of its population. Writing in the May 2023 edition of DIA’s Global Forum magazine, Jun Feng and Alex Best of Janssen Singapore and Kristy Lim of Janssen South Korea highlight how countries in the Asia-Pacific region…

Middle East Regulatory Landscape: Collaboration, Agility, and Adaptation

MENA / Amira Younes of AbbVie UAE examines how the COVID-19 pandemic highlighted the need for new ways of thinking about delivering regulatory effectiveness and efficiency in the region, and for flexibility from all stakeholders to ensure that therapies continue to reach patients in a timely manner.   Most countries in the Middle East already had priority or…

Maintaining Good Clinical Practice During War

Ukraine / Igor Bondarenko of Ukraine’s Dnipro State Medical University, Evgeny Levenko from clinical trials company, ARENSIA, and Olena Popova from IQVIA offer their perspectives on maintaining quality and ensuring participant protection in clinical trials in Ukraine during wartime.   The ongoing war places unprecedented pressure on the healthcare system and clinical trials in Western Ukraine, and…

Ethical Considerations: Clinical Research in Wartime Ukraine and Beyond

Ukraine / The March edition of DIA’s Global Forum magazine features a special section on clinical research in Ukraine, over one year on from the beginning of the Russian invasion. Here, Chieko Kurihara of Kanagawa Dental University, Japan; Victoriia Dobrova of Ukraine’s National University of Pharmacy; Francis P. Crawley of the Good Clinical Practice Alliance – Europe…

From COVID-19 Pandemic to War: Clinical Trial Industry Powers on Under Extreme Conditions

Ukraine / The March edition of DIA’s Global Forum magazine features a special section on clinical research in Ukraine, over one year on from the beginning of the Russian invasion. Anina Adelfio of the Association of Clinical Research Organizations (ACRO) looks back on an extremely challenging two years for the clinical trial industry, which has managed to…

Africa: Reversing the Impact of Omitting More than One Billion People from Global Research

Africa / As part of a special focus on drug development and clinical research in Africa in February 2023’s DIA Global Forum magazine, Lisa Ursella Collins of Innomas Clinical Research, Leslie Sam from Leslie Sam and Associates, Jayesh Pandit, a Patient Safety Advocate from Kenya, Helen Ndagije of the Uganda National Drug Authority, and Wangui Mathenge from…

Japan’s Next-Generation Medical Infrastructure Law: Appropriate Use of Individual Medical Information

Japan / Writing in the February 2023 edition of DIA’s Global Forum magazine, Yumi Wakabayashi of Janssen, Takahiro Horimatsu from the Institute for Advancement of Clinical and Translational Science at Kyoto University, Hiroshi Asai of Astellas, Yasuhiro Himeno from the Government of Japan’s Cabinet Office, and Hiroyuki Taruno of the Cancer Institute Hospital at the Japanese Foundation…

The New EU Health Technology Assessment Regulation: Building Optimal Regulatory & HTA Collaboration

Europe / Edward Mc Gettrick and Sharon Gorman of Pfizer, writing in the January 2023 edition of DIA’s Global Forum magazine, examine the scope and impact of the European Union’s new Regulation on Health Technology Assessment.   In December 2021, the European Commission (EC) adopted the Regulation on Health Technology Assessment (EU HTA Regulation; No. 2021/2282). Its main…

Pharma R&D in Japan: In Need of an Upgrade

Japan / MSD KK’s Fumitaka Noji, writing in the January 2023 edition of DIA’s Global Forum magazine, outlines some of the key upgrades that Japan’s innovation ecosystem needs to become globally competitive once again, namely around strategy and information, investment, and finding qualified experts.   Although the importance of open innovation in drug research and development has…

A Viable EU Regulatory System Must be a Cornerstone for Innovation in Europe

Europe / Writing in the special December 2022 edition of DIA’s Global Forum magazine, Eli Lilly’s Mark Mayer, Pfizer’s Nick Sykes and Julie O’Brien, and the EFPIA’s Sini Eskola, Magda Chlebus, and Chloé Garay look at the EU regulatory system’s resourcing challenges and call for long-term multi-stakeholder engagement to help resolve them.   The European Union (EU)…

Decentralised & Digitalised: Patient-Centric DCTs in China

China / Writing in the special December 2022 edition of DIA’s Global Forum magazine – which focuses exclusively on decentralised clinical trials – on behalf of the DIA China Digital Health Community (DHC), Takeda’s Alicia He and Pfizer’s Mia Sun examine the progress made on decentralised and digitalised trials in China.   The concept of DCT is…

Right Time for Roadmap to Harmonising RWE? EU Industry Perspective on Future Directions

Europe / Writing in the DIA Global Forum’s special November 2022 issue on the Digital Virtuous Loop Karin Van Baelen and Susan Sandler – both of Janssen – and AbbVie’s Álmath Spooner look at Europe’s progress towards true real-world evidence integration and its potential impact on decision making across the healthcare continuum.   Real-world evidence (RWE) policy…

Four Fundamental Components of a Successful Decentralised Clinical Trial

USA / A boom in decentralised clinical trials was an unexpected effect of the COVID-19 pandemic and subsequent lockdowns. However, these trials require expertise and technology that can differ significantly from those needed for clinical trials, as Curavit Clinical Research’s Joel Morse writes in the DIA Global Forum’s special November 2022 issue on the Digital Virtuous Loop.…

China Sets New Record for Local Drug Approvals in 2021

China / DIA Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from 2019 through 2021: from 34 new chemical drugs and 19 biological products in 2019 to 37 new chemical drugs and 24 biological products in 2021. This podcast explores…

Evolving Compassionate Use and Named Patient Programs Across Asia Pacific

Asia-Pacific / Through compassionate use programs patients suffering from critical, life-threatening conditions can access potential life-saving therapeutic options which have not been formally approved by the responsible health authority in an ethical and regulated way. ChongXiang Tan, Fengyun (Vicky) Han and Annetta C. Beauregard of Janssen Pharmaceutical Companies of Johnson & Johnson discuss the need to evolve…

Japan’s New Emergency Regulatory Approval System

Japan / Pfizer’s Kaneko Miyuki, writing in the September 2022 edition of DIA’s Global Forum magazine, shines a light on Japan’s new emergency approval system for pharmaceuticals. Enacted in the wake of the COVID-19 pandemic, Japan hopes that this new regulation will allow for a more rapid and agile response to future health crises.   As of…

Digitalisation in the ASEAN Pharmaceuticals Market

ASEAN / Takeda’s Soon Yee Chow and Helene Sou, writing in the September 2022 edition of DIA’s Global Forum magazine, outline how digitalisation initiatives, if properly enacted, can help the ASEAN region achieve its vision of a free-trade market for high-quality and safe drugs across member states.   One key pillar of the Association of Southeast Asian…

Patient-Centricity and Product Quality: A Global Leadership Opportunity

Global / Sarah Pope Miksinski, executive director/CMS regulatory affairs, and Gregory Rullo, senior director regulatory affairs, at AstraZeneca discuss the need for common ground among regulators and industry when it comes to patient centricity and for strategic leadership to address differing regulatory control-strategy requirements. In today’s increasingly complex and intricate pharmaceutical landscape, industry and regulators alike frequently…

The Future of Healthcare Is … Inclusive, Global, Individual, Digital

Global / DIA 2022 convened with an opening plenary that explored the question What is the Future of Healthcare? from four connected perspectives—Inclusive, Global, Individual, Digital.   Barbara Lopez Kunz, Global Chief Executive, DIA “We’re here this week because we imagine a world where powerful health interventions and tools are rapidly discovered, developed, approved, and made accessible…

Patient-Centric Healthcare in India & The National Patient Safety Implementation Framework

India / Arshia Bhandari of patient safety thought leadership forum PhVFIT examines how India is embracing a more patient-centric healthcare model via the implementation of a national patient safety implementation framework.   In April 2018, the India Ministry of Health and Family Welfare launched the National Patient Safety Implementation Framework 2018-2025 (NPSIF), a comprehensive guideline and roadmap…

Progress Toward African Medicines Agency & Vaccine Manufacturing in Africa

Africa / David Mukanga of the Bill and Melinda Gates Foundation gives an overview of the latest developments on the long road towards the creation of an African Medicines Agency and the push to establish vaccine manufacturing facilities on the continent.   Since the minimum number of 15 ratifications by African Union (AU) countries was reached to…

Regulatory Trends in LatAm & the Caribbean

Americas / Collaboration, convergence, and other best practices have been at the center of discussions related to the regulatory environment in Latin America and the Caribbean, including DIA’s Latin America Regulatory Conference (LARC) 2022, where voices from global regulators, regional and international organizations, industry, and academia discussed the strategies supporting current practices and future trends in regulatory activities…

Real-World Evidence Regulatory Landscape in Asia Pacific

Asia-Pacific / Writing in the June edition of DIA’s Global Forum magazine, Ellen Sem, Fengyun (Vicky) Han and Annetta C. Beauregard from Janssen Pharmaceutical Companies of Johnson & Johnson, outline the real-world data (RWD) and real-world evidence (RWE) regulatory landscape in Asia Pacific.  Real-world data (RWD) and real-world evidence (RWE) have played an increasingly important role in regulatory…

Drugs Approved by the Chinese NMPA in 2021

China / Writing in the May edition of DIA’s Global Forum magazine, Xu Wang of Novo Nordisk China looks at the new drug approvals in China in 2021. Among other highlights, the approval of two CAR-T products signal that CAR-T treatment has finally entered the commercialization stage. The number of new drug approvals in China set a…

How to Future-Proof the EU Medicines Regulatory System

Europe / Nick Sykes of Pfizer discusses the European Commission’s intention to “future-proof” the EU regulatory system and the suggestions for changes that were discussed througout the DIA Europe 2022 meeting. From the May edition of DIA’s Global Forum magazine. In its Pharmaceutical Strategy, the European Commission intends to “future-proof” the EU medicines regulatory system. What does…

Shaping Future-Oriented R&D Talent Innovation in China

China / Writing in the April edition of DIA’s Global Forum magazine, the DIA China Leadership and Career Community look at the Chinese pharmaceutical innovation ecosystem’s R&D talent gap and the China Pharmaceutical R&D Talent Innovation Research Project that was launched to address it.   Over the past five years, China’s pharmaceutical innovation industry has experienced what has been…

Australia National Medicines Policy Revision Reshaped by Community Feedback

Australia / Writing in April edition of DIA’s Global Forum magazine, the University of New South Wales’s Richard Day looks at Australia’s National Medicines Policy (NMP) and how it is being reshaped by community and stakeholder feedback.   Australia’s National Medicines Policy (NMP), gazetted in 2000, is being revised and the draft policy was made available for final, widespread…

Faster and More Flexible: Regulatory & Industry Leadership in Latin America During the Pandemic

LatAm / Writing in the March edition of DIA’s Global Forum magazine, the University of Southern California’s Viktoria Magyar looks at how Latin American regulatory bodies adapted to the COVID-19 pandemic and what some of its longer-term impacts on regulatory activities in the region might be.   Driven by increasing workloads, limited medical supplies and expertise, and…

Over a Billion COVID-19 Vaccine Doses: How Did India Do It?

India / Writing in the March 2022 edition of DIA’s Global Forum magazine, Ananya Chakraborty from the Vydehi Institute of Medical Sciences & Research Centre outlines the key factors behind India’s successful COVID-19 vaccination program.   January 16, 2022, was a proud day for India. The country achieved the milestone of completing one year of the world’s…

Implementing New GVP in China Requires Digitalisation and Training

China / Writing in the March 2022 edition of DIA’s Global Forum magazine, Jessie Zhu of Deltamed Co. Ltd./Pharmaron Clinical and Monica Juping Xu of Taimei Medical Technology outline the progress of pharmacovigilance standards in China, and make the call for greater levels of digitalisation and training.   Since China joined ICH in 2017, much effort has…

Oncology: Ripe for Decentralised Research

Global / Writing in the February edition of DIA’s Global Forum magazine, Candice Del Rio of Curavit Clinical Research examines the applicability of decentralised clinical trials in oncology research, and their positive impact on both decreasing patient dropout rates and increasing patient engagement. Oncology represents the largest research area globally, with 6.5 percent annual growth from 2000 to…

An Assessment of Regulatory Submissions in East & West Africa

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 African and West African communities.…

Artificial Intelligence Can Save Pharmacovigilance in Australia

Australia / Writing in the January edition of DIA’s Global Forum magazine, Julia Chan, David Liew, Jana Stojanova, and Chris McMaster of Austin Health, Melbourne and St. Vincent’s Hospital Sydney outline how artificial intelligence (AI) solutions can best be applied to pharmacovigilance in Australia, and the challenges that stand ahead.   For healthcare professionals in Australia, pharmacovigilance…

China: Emerging Pharmacovigilance Framework Ensuring Safe COVID-19 Vaccines

China / PPC China’s Sophia Duan, writing in the January edition of DIA’s Global Forum magazine, details how the emergence of an effective pharmacovigilance ecosystem is helping to safeguard the rollout of COVID-19 vaccines in China.   Since the breakout of COVID-19, many pharmaceutical companies in China have worked to develop preventative vaccines. In response, China’s regulatory…

EUnetHTA 21 Launches Joint Scientific Consultations for Regulators, HTAs, and Sponsors

Europe / Writing in the December edition of DIA’s Global Forum magazine, Thomas Kühler updates his August piece on the progress towards a unified HTA system in Europe and the objectives of the recently launched EUnetHTA 21 initiative.   Global Forum recently published a piece on Health Technology Assessment (HTA) in the EU and how a regulation that had been the subject…

Key Features of Orphan Drug Registration in Singapore, Malaysia, Philippines, and Vietnam

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 as US FDA, EMA, and…

Aligning Stakeholder Partnerships in Latin America: Best Practices from Cuba & Mexico

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 forward.   The COVID pandemic…

Australia Aiming Targeted Therapies Toward Truly Personalised Medicine

Australia / In conversation in the November issue of DIA’s Global Forum magazine, Australian Pharmaceutical medical and scientific Professionals Association (APPA) Past President David Grolman highlights the contributions that Australia is already making to the global innovative pharmaceutical industry and why his country remains a particularly attractive clinical trials hub.   “We are entering an extremely exciting…

CADTH CEO Suzanne McGurn on the Key Challenges in HTA Today

Canada / In conversation in the October edition of DIA’s Global Forum magazine, Canadian Agency for Drugs and Technologies in Health (CADTH) CEO Suzanne McGurn highlights how the work of HTA bodies like CADTH has evolved, the most significant challenges in their work, international collaboration, and RWE integration.   Health technology assessment (HTA) is the evaluation of…

PMDA Chief Executive Yasuhiro Fujiwara on Regulatory Utilisation of RWD & RWE in Japan

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.   Real-world data (RWD) and real-world…

Regulatory Cooperation & Joint Assessments in ASEAN

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 bodies on the joint assessment…

Concrete Steps Toward National Pharmacare in Canada

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 Advisory Panel for Pan-Canadian Prescription…

The COVID-19 Pandemic in Japan: Treatments, Vaccines & Remote Study Audits

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 tools in clinical studies. Patients…

Health Technology Assessment in the EU: Back and Forth in Giant Strides

Europe / Writing in the August edition of DIA’s Global Forum, Sanofi R&D’s Thomas Kühler outlines the bumpy journey towards the full adoption of Health Technology Assessment (HTA) across Europe.   More than three years ago, in January 2018, the European Commission published a draft Regulation on Health Technology Assessment for the EU. The intention was to secure…

Enhancing Patient Engagement in Clinical Trials in Japan

Japan / Writing in the July issue of DIA’s Global Forum magazine Pfizer R&D Japan’s Atsushi Kitamura examines how both pharmaceutical companies and patients in Japan can help increase patient engagement in the clinical trial process.   Patient engagement in clinical trials in Japan has been progressing steadily in the last few years. Pharmaceutical companies and patients…

Decentralised Clinical Trials in APAC Here to Stay

Asia-Pacific / Writing in the July issue of DIA’s Global Forum magazine Serene Ong and Gaurang Majmudar of clinical trial logistics specialists Marken outline why the shift to decentralised clinical trials brought about by COVID-19 is likely to stay in place post-pandemic.   The face of clinical trials has been changing rapidly, and while decentralised clinical trials…

Impact of COVID-19 on US Clinical Studies Conducted by Japan-Based Pharmaceutical Companies

Japan / Writing in the June edition of DIA’s Global Forum magazine, representatives of Japanese pharmaceutical companies with US operations outline how the COVID-19 pandemic affected their ongoing clinical studies.   The spread of COVID-19 and the resulting social activity restrictions have severely impacted drug development and threatened the continuity of clinical trials in the US. Japanese…

China’s New Era of Reform Transforming Regulatory Professionals

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 years of China’s National Medical…

APAC: Self-Medication in the Age of COVID: The Country-Specific Role & Acceptability of OTC Medicines

Asia-Pacific / Writing in the May edition of DIA’s Global Forum magazine, Toshiyoshi Tominaga of the Asia-Pacific Self-Medication Industry (APSMI) looks at the landscape for OTC medicines in the Asia-Pacific region today. Tominaga highlights how, against the backdrop of a drop in formal medical interventions due to COVID-19 infection fears, countries are more than ever having to balance the…

Australia: Growing Clinical Trials Even in Pandemic’s Wake

Australia / In an exclusive new podcast, DIA Global Forum Australia/New Zealand Regional Editor Richard Day (University of New South Wales, Medicine, St. Vincent’s Hospital) and John Skeritt, Head of Australia’s Therapeutic Goods Administration (TGA), discuss regulatory strategies and other initiatives designed to help nurture clinical research and product development in Australia post-pandemic.   With “Australia having had many fewer…

USA: Importance of the Patient Voice in Drug Development: Eosinophilic Esophagitis as a Case Example

USA / Writing in the May edition of DIA’s Global Forum magazine, Erica Lyons, Sarrit Kovacs, Matthew Kowalik, and Jessica Lee from the Division of Gastroenterology, Office of New Drugs, CDER at the US FDA look at how patient input is increasingly being utilised in new drug development, its importance in assessing a drug’s benefit, and the…

Aligning Combination Product Regulations in Asia-Pacific: A Distant Dream?

Asia-Pacific / Writing in the April edition of DIA’s Global Forum magazine, Dhiraj Behl, Janine Jamieson, and Harikesh Kalonia highlight some of the regulatory challenges for drug-device combination products in APAC, including the lack of an international body dedicated to harmonisation in this field.   In the current innovation era and in the wake of COVID-19, two topics of…

Importance of Reliance to Support Strengthening Latin American & Caribbean Regulatory Systems

LatAm / Writing in the April edition of DIA’s Global Forum magazine, Maria Cristina Mota Pina of Abbvie on behalf of FIFARMA Regulatory & Biologics Working Group highlights the significance of regulatory reliance between regulators in the LatAm and Caribbean region and proposes how it can be strengthened.   Regulatory reliance is increasingly used around the world…

Canada: Federal Consultations on a National Strategy for Rare Disease Drugs

Canada / Writing in the March edition of DIA’s Global Forum magazine, Judith Glennie examines the findings of Health Canada’s consultation with Canadians on what a national strategy for high-cost rare disease drugs could look like.   On January 27, 2021, Health Canada launched a consultation on the development of a National Strategy for High-Cost Drugs for…

Accelerated Regulatory Assessment of Innovative Medicines in Latin America

Americas / Writing in the March edition of DIA’s Global Forum magazine, EMD Serono’s Ana Padua outlines the findings of a recent study into accelerated regulatory pathways in Latin America which aim to reduce approval timelines for innovative medicines.   The Latin America region offers a number of registration pathways to accelerate the regulatory assessment of innovative…

After Brexit: Focus on the New Pharmaceutical Strategy for Europe

Europe / Writing in the February edition of DIA’s Global Forum magazine, Thomas Kühler of Sanofi R&D looks at the future of European pharma post-Brexit, with the UK diverging from the rest of the continent in regulatory terms and the launch of the European Commission’s Pharmaceutical Strategy for Europe.   After four and a half years of…

New Drug Approvals in China in 2020

China / Writing in the February edition of DIA’s Global Forum magazine, Xu Wang of Novo Nordisk Pharma China and Xiaoxi Wang from the Shanghai Center for Drug Evaluation & Inspection analyse the Chinese NMPA’s drug approval list for 2020, including a surge in approvals for locally developed drugs.   In the tumultuous year of 2020, the…

See more