Regulatory Focus™ > News Articles > IOM Calls for Regulatory Harmonization

IOM Calls for Regulatory Harmonization

Posted 28 November 2012 | By

The Institute of Medicine (IOM) wants the practice of regulatory affairs to be a little bit easier, particularly for low-resource countries and companies conducting international clinical trials.

In an announcement on 28 November 2012, the prestigious healthcare agency said it plans to hold a meeting on regulatory harmonization, the process by which countries and organizations standardize their regulatory processes.

IOM has long been interested in regulatory topics. Within the last year alone, it has issued reports on regulatory in regards to disaster response, clinical trials, safety inspections, biomarkers, approval acceleration, drug safety, animal research, regulatory capacity, 'omics' test development and healthcare outcomes.

[Editor's note -- Full disclosure: RAPS is involved in some of IOM's regulatory efforts, particularly those related to regulatory capacity.]

Harmonization has the potential to affect nearly all of the above areas, IOM said in a statement. For example, clinical trials and investigational studies are often conducted outside the US, where the costs of conducting the trials are significantly less. If that country's trials requirements are different than that of the US or EU, companies could be forced to replicate or re-do trials for every country they wish to gain market access to, increasing both costs and the waiting time for patients to access a product.

Countries with limited regulatory capacity could especially benefit from regulatory harmonization, IOM wrote. Regulators have already put harmonization efforts into practice in some historically low-capacity regions, such as the Middle East, where a regulatory approval from the Saudi Food and Drug Administration (SFDA) can mean access to several other nearby countries. Similar models have been floated for adoption in Africa as well.

"There is a need for globally harmonized, science-based standards for the development and evaluation of safety, quality, and efficacy of medical products - both to enhance the efficiency and clarity of the drug development and evaluation process, and ultimately to promote and enhance product quality and the public's health," IOM explained in its meeting notice. "There is also need for harmonization of standards for ongoing safety and quality surveillance of marketed biomedical products."

IOM is hardly the only entity working in this space. The International Conference on Harmonization (ICH) and the International Medical Device Regulators Forum (IMDRF) harmonize, respectively, standards for pharmaceutical and medical device products. But more work is needed, IOM argues.

"This public workshop will address needs for international harmonization of regulatory standards to support the development, evaluation and surveillance of biomedical products. Specifically, the discussions at the workshop will help identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards."

The meeting will be held between 13 and 14 February 2013 at the National Academy of Sciences building in Washington, DC.


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