Not-For-Profit Launched to Improve Global Harmonization of Regulatory Requirements

Elmwood Park, N.J. – January 4, 2011 – The Regulatory Harmonization Institute (www.regulatoryharmonization.com), an international, not-for-profit association dedicated to global harmonization of drug and medical device regulatory requirements, today announced the launch of its Web site, programs and initiatives to affect the development and introduction of meaningful therapies to patients worldwide. Members include government organizations, public/private companies, patient advocacy organizations, not-for-profit entities, academic professionals and other industry groups.

The members of RHI share a deep, broad range of experience and interest in international regulatory requirements. RHI founding organizations and members include:

BIO
National Council for Prescription Drug Programs
GPhA
Korea Health Industry Development Institute
CPR Strategic Marketing & Communications
Pharma Intellectual Resource Services, LLC
Anthony Bonelli Associates, LLC
D2 Pharma Consulting, LLC
Centric Health Resources, Inc.
Kinexum
McGuire Woods
Martha Brumfield & Associates, LLC
Mission Pharmacal
Polaris Life Sciences
Peter Honig, M.D., M.P.H.        AstraZeneca
Kazuko Aoyagi, Ph.D.              Celerion
Colin Vickers Ph.D.                  Eisai
Mary Jane Nehring                  Bausch & Lomb
                             
“Our mission is to enable more efficient delivery of high quality, safe and efficacious therapies to all patient populations by advancing global harmonization of regulatory requirements for medical products and devices intended for human use,” says Dean Erhardt, president of RHI and principal at D2 Pharma Consulting. “Without greater support for international cooperation between and among regulatory authorities and their constituent stakeholders, patient access to important medical products will continue to be unnecessarily delayed -- particularly as staggering development requirements drive unsustainable cost models and significant delays in getting products approved across multiple countries.”

Building upon the work of other associations and organizations that continue to work independently on many differing aspects of harmonized regulatory requirements, RHI activities are tied to participation among industry regulatory representatives from drug manufacturers and researchers in all countries that have a stake in the outcome of how the quality, safety, and efficacy of drugs will ultimately be adjudged in their communities vs. the global community.

Erhardt concludes, “Quite simply, if industry and other interested stakeholders are interested in helping patients across the globe to gain access to innovative, high quality products, we need to increase our engagement with regulatory authorities in the multiple international forums in which they are already working.”

About Regulatory Harmonization Institute:
Regulatory Harmonization Institute, Inc. (RHI) is a non-profit association dedicated to global harmonization of regulatory requirements with a mission to influence the development and introduction of meaningful therapies to patients across the globe. RHI will advance global harmonization of regulatory requirements for medicines and devices intended for human use, enabling greater delivery of meaningful new therapies to all patient populations.


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