Why RHI

  • RHI is a membership organization whose mission is singularly focused on matters related to regulatory harmonization.
  • RHI is open and inclusive; manufacturers, sponsors, distributors, consultants, academia, regulators, and other interested stakeholders are all invited to join. RHI has work streams under development to accommodate virtually every aspect of the biopharmaceutical and device industries, as well as others sectors developing products used to promote health.
  • There are a large number of regional harmonization initiatives among regulatory authorities having some political support, but little financial or technical support (e.g., APEC-LSIF, PANDRH, AU RECs, etc.) Representatives from both local and multi-national industry in these initiatives is extremely scarce, even though they are usually invited participants, are key stakeholders partners in regulatory decision-making, and are necessary for enhancing patient health across the globe.
  • Working together, representatives from local and multi-national industry can and must drive science and risk based regulatory requirements. Without their active participation, the likelihood for successful harmonization outcomes will continue to be a growing problem.
  • We must ensure that there is a global perspective brought to these important efforts (e.g., orphan drug in the US may be a major disease state in Africa or parts of China, and 'neglected diseases' are currently handled in varying ways by the US and the EU).
  • RHI is a bridge between the activities and efforts of the drug regulatory authorities and representatives of industry located all over the globe
  • RHI:
    • Works toward adoption of harmonized regulatory requirements
    • Provides topic driven workshops to enhance information exchange and increase opportunities to understand and address global harmonization issues
    • Develops a compelling business case for harmonization and disseminate it across industry and government agencies

Simultaneous Global Development

  • In any given market, drug discovery and development leading to regulatory approval is extremely risky and expensive.

    1 in 10,000 candidates (new molecular entities) obtain approval at a cost of approx. $1.2 billion in the US alone.

  • Due to lack of consistent regulatory requirements across national borders, the most pervasive drug development strategy is staggered development: first in the US and/or Europe, and then to other markets.

    This leads to long "drug lags" in even the most developed countries (e.g., 5 years in Japan), and much longer lags in other parts of the world.

  • A better development strategy is Simultaneous Global Development (SGD). Whether generic, innovative, small molecule or biotech, a necessary step in achieving SGD requires addressing the lack of globally consistent, science and risk-based, regulatory requirements.