Executive Leadership | Editor’s Message

To Our Readers

Harmonize, Converge, Rely: How Convenient!

Alberto Grignolo
Fellow of DIA


wenty-eight years ago, the concept of “regulatory harmonization” entered our vocabulary and daily lives when ICH (the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) was launched to add efficiency and reduce duplication of effort in drug development.

To date, ICH has produced more than 50 harmonized and profoundly impactful Guidelines, and has engaged an increasing number of members – most recently Brazil, China, and South Korea – and official observers. It’s a success story.

Then came the concept of “regulatory convergence” to reflect the alignment (not the full harmonization) of regulatory requirements based on shared principles for achieving public health goals. Many countries and regions (including parts of Africa, ASEAN, and the Americas) have adhered to this notion and have applied it to varying degrees.

“Regulatory reliance” has recently emerged as a driver of cooperation and efficiency among regulators. In this issue of Global Forum we publish a report from Swissmedic that illustrates the practical application of regulatory reliance in the review of the marketing application for a generic drug. This model will likely be applied in the future and to other products. Joining forces and sharing resources, regulators in Australia, Canada, Singapore, and Switzerland were able to review the application efficiently, share learnings, avoid duplication of effort, and build mutual confidence.

There are even more examples of “reliance” these days. Several are illustrated in this issue: the decade of work undertaken by CTTI (Clinical Trials Transformation Initiative) has relied on the work of numerous stakeholders; success in drug development relies increasingly on advances in translational science and on listening to the input of patients when sponsors design clinical trials; preparedness for pandemics relies heavily on global cooperation and rapid reaction times; the progress of innovation in Japan relies on the availability of (currently scarce) venture funding; even the move of EMA to Amsterdam relies on the availability of adequate office space there.

Reliance is frequently necessary, sometimes attractive and occasionally convenient. But is convenience always a good thing? Some have argued that convenience in our daily lives (including online shopping and the entry of intelligent devices into our homes) is depriving us of the satisfaction of finding solutions to difficult problems. No one would claim today that drug development is easy or convenient; but it is certainly far more convenient (and in some ways less satisfying and heroic) to submit an eCTD today than it was to physically compile and proudly ship to regulatory agencies a drug marketing application comprising hundreds of volumes of paper in the decades before ICH produced the Common Technical Document template and its electronic version.

Will precision medicine make it fast and convenient to match a patient to the right medicine within a few seconds? Will wearable devices and telemedicine eliminate the need for the patient to see a doctor, who will be replaced by an intelligent machine? Will convenience depersonalize our humanity, weaken our coping skills, and deprive us of the satisfaction of achieving difficult things?

ICH has taught us that overcoming inconvenience, inefficiency, and duplication by working together towards common goals is a rewarding achievement.

There is still a great deal of “inconvenience” to be overcome in healthcare product development and access today. Much more effort is needed.

We can rely on that.

Alberto Grignolo, PhD
Global Forum Editor
Fellow of DIA

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