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Jane E. Henney, M.D. - ICH5

This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Remarks by:
Jane E. Henney, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration

The Fifth International Conference on Harmonisation of Technical
Requirements
for
Registration of Pharmaceuticals for Human Use

(ICH5)

The Common Technical Document
"Putting it All Together"
A Decade of Harmonization

"Science-based Regulation and International Cooperation"

San Diego, California, USA
November 9, 2000

Good afternoon. I'm delighted to be here today to reflect upon the great progress made by ICH, to congratulate those of you who've worked so tirelessly to make it happen, and to look ahead as we chart the next phase of this incredible journey.

Henry David Thoreau, a well-known American writer, naturalist and philosopher, once said, "If one advances confidently in the direction of his dreams, and endeavors to live the life which he has imagined, he will meet with success unexpected in common hours."

I can think of no better description than this, of the very ambitious goals that were set, the difficult challenges met, and the many accomplishments achieved on this 10th anniversary of the International Conference on Harmonization.

These accomplishments represent a decade of intense effort by an international community of science from both the regulatory and the industrial sectors. All have worked diligently to resolve very difficult and complex issues. After ten years of dedication and commitment--yes...long days and late nights, extensive travel and exhaustive meetings, what has been accomplished is what many believed in the beginning could never really happen. We've come from diverse cultures and many languages, different systems of government, and a widely varied array of regulatory philosophies. Yet our goal has been to harmonize, and make more efficient, our regulatory process.

We shared a vision. The vision of building a bridge that would span these many differences, and streamline the drug and biologic development process on an international scale.

A bridge that would provide a straight and consistent course for the review process, that would maintain our high standards of safety while bringing needed health care products to patients and consumers in a timely way.

The construction material used for building this bridge would be science for grounding our thinking and decision-making for it provides strength and stability through its objective methods and because it provides a language common to all.

This bridge also was designed to permit open access and encourage entry for all who seek to travel on it. As an international community, ICH benefits each of us, individually and collectively. As member countries, none of us considered the International Conference on Harmonization to be an exclusive club. One of the guiding principles from the inception of ICH has been that all the deliberative processes would take place in an open and transparent venue, and decisions and guidance would be available for comment and feedback from all countries, not just ICH member countries.

To this end, all the ICH documents and guidelines have been made available on our individual websites and on the website maintained by the ICH secretariat, through workshops, and with conferences such as this one.

The World Health Organization and the International Federation of Pharmaceutical Manufacturers Association also deserve credit for enhancing the transparency of the process and the availability of information. These two pivotal organizations have played critical roles in communication and in distributing the ICH documents to both member and nonmember countries.

To address the concerns raised by many countries who haven't been part of the formal ICH process, the ICH has charged a subgroup of the Steering Committee--the Global Cooperation Group--to identify approaches to respond to these concerns. The GCG's focus is on communicating and identifying ways to support those countries that are now actively involved in drug and biologic development, and want to use the ICH guidelines.

Today, we have much to celebrate. We now have over 45 topics harmonized in the areas of efficacy, safety and quality. We have a common international medical dictionary, MedDRA-an amazing accomplishment in itself, and electronic standards to facilitate the electronic transfer of information between regulators, and between industry and regulatory agencies. And now we have the Common Technical Document.

The Common Technical Document serves many purposes and, as we're seeing already, has benefits far beyond those originally envisioned. Our original goal was to create a simplified, harmonized system for submission of applications throughout our three regions. And we've succeeded.

By harmonizing scientific terminology and technical requirements, the regulatory maze has been greatly simplified for easier navigation by the pharmaceutical companies each time they develop data for an application to be submitted to the regulatory body in one or more of our regions.

The Common Technical Document will be enormously helpful to scientific and medical reviewers, and to the review process itself, because applications submitted by industry will be in a standardized format. This will bring uniformity to the documentation submitted to each region and potentially open the door to greater cooperation among our review activities in the future.

These successes have spawned even greater achievements and opportunities. The Common Technical Document and, indeed, all facets of ICH are providing regulatory guidance for countries around the world. While the initial participants of ICH include the European Union, Japan and the United States, ICH's influence is spreading far beyond these borders. The ICH guidelines are providing a blueprint for harmonization around the world.

Many countries in Asia, Latin America and the Middle East, for example, have already begun to use various ICH guidelines and now have a model to work from and to complement the documents provided by the World Health Organization. As the scientific progress of drug and biologic development matures in these parts of the world and as these countries enhance their regulatory infrastructures, they are looking to ICH guidelines for international standards and leadership.

The next powerful tool to come online will be the electronic submission of data. Imagine being able to submit essentially the same core sections of the application to several countries simultaneously. It sounds simple...it's a natural extension of the information age. We're accustomed to sending and retrieving vast amounts of information with the click of a mouse. But those of us here today realize and appreciate the immense effort required to bring this to fruition. Yet it's happening.

Another major area of ICH activity is in the post-market arena, where we're beginning to see the benefits of a harmonized adverse event-reporting document. The elements of this document will be the same for all three regions. Soon industry will be able to submit adverse event reports electronically, to all regions at the same time. Standardized terminology and the international dictionary that has been created and adopted will have a tremendous impact in this area.

Our success will be measured not only by our ability to receive this data but by how it will be used in our mutual efforts to manage the risks of products brought to market.

By sharing adverse event data in a timely way we will be better equipped to respond quickly to problems associated with the use of a particular product marketed anywhere in the world. This is an area where data shared and used in a proactive, well-harmonized manner will greatly benefit the public we seek to serve.

Before I close let me say that these great benefits of harmonization have, and will continue to have, a high cost. The cost is most apparent in terms of dollars--provided by both industry and regulatory bodies in the three regions. There is also the cost of time and energy that must be dedicated to this effort by many on our scientific and regulatory staff.

As leaders we must recognize this but also recognize the value that has been and will be achieved by these efforts. We must remain champions not only by our praise for what has been done in our yesterdays but unwavering in our support, dedication and commitment to the work ahead.

Let me assure you that FDA is deeply committed to this process.

We look forward to our continued harmonization activities in the days, months and years to come.

I'd like to offer a special thank you to the ICH steering committee for your vision and your devotion to the ICH. Without your years-long efforts we would have little to celebrate on this occasion. But these few also required the many of you who make up this audience and others who were unable to attend. We are in your debt as well for your talents, energy, and commitment to excellence.

Frank Lloyd Wright, an American architect of vision whose structures were known for being in harmony with their environment said, "I know the price of success: dedication, hard work and an unremitting devotion to the things you want to see happen."

Thanks to each and every one of you for paying that price - and thank you very much for inviting me here to celebrate with you.