Dr. Frances Kelsey played a pivotal role in shaping modern drug regulation. Early in her career, she contributed to the investigation of the Elixir Sulfanilamide tragedy in 1937¹, where a toxic solvent led to over 100 deaths in the U.S., prompting significant legislative changes to the 1906 Food and Drug Act. Later, as an FDA reviewer, she famously blocked the approval of thalidomide in 1960² due to insufficient safety data, preventing a potential public health disaster in the United States.
She wasn’t alone. Between the 1960s and 1990s, several events forced the world to re-examine how clinical research was conducted.
The Tuskegee syphilis study (1932–1972), where treatment was knowingly withheld from participants, led to the Belmont Report in 1979³—a foundational document promoting three principles in research: respect for persons, beneficence, and justice. Meanwhile, the World Medical Association introduced the Declaration of Helsinki in 1964⁴—a set of global principles to protect people involved in medical research. It emphasized informed consent, independent ethics review, and balancing risks and benefits.
But while ethics were improving, each country still had its own way of testing and approving medicines. The technical standards remained disconnected, and that slowed everything down.
The world needed more than ethics—it needed a shared process.
By the late 1980s, that realization had become urgent. Drug development was going global, but regulations remained local. Pharmaceutical companies faced rising costs and long delays, often repeating the same trials in every region. Regulators, too, saw the inefficiency and risk in working in silos.
It was time to align—not just in principle, but in process.
The U.S. Food and Drug Administration (FDA), established in 1906 and headquartered in Silver Spring, Maryland, had long served as the country’s gatekeeper for drug safety. It worked closely with pharmaceutical giants like Pfizer, Merck, and Johnson & Johnson, who were key members of PhRMA (Pharmaceutical Research and Manufacturers of America), founded in 1958 and based in Washington, D.C.⁵
On the other side of the world, Japan’s Ministry of Health and Welfare (now the Ministry of Health, Labour and Welfare), established in 1938 and headquartered in Tokyo, followed a more cautious path, often requiring local clinical trials before allowing new medicines on the market. Well-known Japanese firms like Takeda and Daiichi Sankyo were instrumental in shaping JPMA (Japan Pharmaceutical Manufacturers Association), founded in 1968 and also based in Tokyo⁶.
Europe, considered the historical heart of modern medicine, carried its own legacy. The European Commission, established in 1958 and headquartered in Brussels, which would later evolve into the European Medicines Agency (EMA), partnered with industry through EFPIA (European Federation of Pharmaceutical Industries and Associations), founded in 1978 and also based in Brussels. EFPIA included major players such as Novartis, Sanofi, and AstraZeneca⁷.
Each of these six bodies—three regulatory authorities and three industry associations—held substantial influence over how medicines were developed and approved across the globe. And for the first time, they came together with a shared goal: to build a common scientific and regulatory language that could speed up innovation, reduce duplication, and ensure patients gained access to safe, effective treatments more efficiently.
In April 1990, representatives from these six organizations came together for a quiet but decisive meeting. It was hosted in Brussels by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
This was not a political summit or media event. There were no public declarations. But the goal was clear: To begin building a shared framework for how medicines should be developed, assessed, and approved across borders.
This meeting marked the beginning of what would later be known as the International Conference on Harmonisation (ICH)—not yet a legal entity, but a structured collaboration.
They agreed to focus first on three core areas: Quality, Safety, and Efficacy—the pillars of every pharmaceutical product.
To turn this vision into action, they formed Expert Working Groups—teams of scientists and regulatory specialists tasked with drafting harmonized guidelines that could apply across regions.
It was a modest start, but it was a shared one.
And for the first time, science—not geography—would lead the way in how the world developed new medicines.
Table 1: ICH Founding Members
| Region | Regulatory Body | Year | HQ Location | Industry Association | Year | HQ Location | Notable Companies |
|---|---|---|---|---|---|---|---|
| United States | FDA | 1906 | Maryland, US | PhRMA | 1958 | Washington, DC | Pfizer, Merck, J&J |
| Japan | MHLW | 1938 | Tokyo | JPMA | 1968 | Tokyo | Takeda, Daiichi Sankyo |
| Europe | European Commission (EMA) | 1958 | Brussels | EFPIA | 1978 | Brussels | Novartis, Sanofi, AstraZeneca |
Abbreviations
Regulatory Bodies:
• FDA – Food and Drug Administration (USA)
• MHLW – Ministry of Health and Welfare (Japan)
• EC/EMA – European Commission / European Medicines Agency (Europe)
Industry Associations:
• PhRMA – Pharmaceutical Research and Manufacturers of America
• JPMA – Japan Pharmaceutical Manufacturers Association
• EFPIA – European Federation of Pharmaceutical Industries and Associations
In our next blog, we’ll explore the structure and framework of ICH — how the organization is organized, the roles of its Assembly, Management Committee, and Working Groups, and how these components function together to develop harmonized guidelines.
We’ll also look at how this framework has evolved to keep pace with the growing complexity and globalization of clinical research.
Stay with us as we continue the CRLA ICH Essentials Series.
📘 Previously: Why ICH Exists (Blog 1)
📘 Also Read: Understanding the Purpose and Structure of ICH (Blog 3)
🧭 Coming Up Next: ICH: The People Behind the Process – Roles That Drive Harmonisation (Blog 4) – coming soon.
- Frances Kathleen Oldham Kelsey – Biography. National Women’s History Museum.
https://www.womenshistory.org/education-resources/biographies/frances-kathleen-oldham-kelsey - Frances Oldham Kelsey: Medical Reviewer Famous for Averting a Public Health Tragedy. U.S. Food and Drug Administration.
https://www.fda.gov/about-fda/fda-history-exhibits/frances-oldham-kelsey-medical-reviewer-famous-averting-public-health-tragedy - The Tuskegee Timeline. Centers for Disease Control and Prevention (CDC), updated 2021.
https://www.cdc.gov/museum/online/story-of-cdc/tuskegee/index.html - Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. World Medical Association (WMA), originally adopted 1964, last amended 2013.
https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/ - About PhRMA and Member Companies. Pharmaceutical Research and Manufacturers of America (PhRMA).
https://phrma.org/About/Members - Pharmaceutical Regulations in Japan – JPMA Handbook. Japan Pharmaceutical Manufacturers Association (JPMA), 2020 Edition.
https://www.jpma.or.jp/english/about/parj/eki4g6000000784o-att/2020e_index.pdf - EFPIA Members – Companies and National Associations. European Federation of Pharmaceutical Industries and Associations.
https://www.efpia.eu/about-us/members/ - JPMA – Member List (English). Japan Pharmaceutical Manufacturers Association.
https://www.jpma.or.jp/english/about/members.html