New Group Targets Global Regulatory Harmonization

A new group has been formed to address global harmonization of pharmaceutical and medical device regulatory requirements.

Elmwood Park, N.J.-based Regulatory Harmonization Institute Inc. (RHI), an international, not-for-profit association dedicated to global harmonization of drug and medical device regulatory requirements, recently launched of its website, and has begun to work on 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. RHI founding organizations and members include:

Anthony Bonelli Associates LLC
AstraZeneca
Bausch & Lomb
BIO
Celerion
Centric Health Resources Inc.
Colin Vickers, Ph.D.
CPR Strategic Marketing & Communications
D2 Pharma Consulting LLC
Eisai
The Generic Pharmaceutical Association
Kazuko Aoyagi, Ph.D.
Kinexum
Korea Health Industry Development Institute
Martha Brumfield & Associates LLC
Mary Jane Nehring
McGuire Woods
Mission Pharmacal
National Council for Prescription Drug Programs
Peter Honig, M.D., M.P.H.
Pharma Intellectual Resource Services LLC
Polaris Life Sciences

“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,” said 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.

“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,” Erhardt added.

On a related note, late last year, the Global Harmonization Task Force (GHTF), which was founded in 1992, announced plans to rebrand and refocus itself as the International Medical Device Regulators’ Forum (IMDRF).

The IMDRF’s management committee will consist of regulators from Australia, Brazil, Canada, China, the European Union, Japan, the United States and the World Health Organization. Australia initially will lead the new group.

The group will continue the GHTF’s effort to push global medical device regulatory harmonization by developing guidance on strategy, policy, directions, membership and activities. The IMDRF also will form ad hoc working groups involving industry, academia, healthcare experts and patient groups to address various issues.

The GHTF announced plans to reorganize into a new organization in early 2011.