Regulatory processes for new technologies

Ensuring safety and effectiveness of health technologies

Before new technologies can be used, they must be assessed and approved by authorized regulatory agencies. Detailed safety review during research and development stages, regulatory approval, and legal registration are necessary parts of product development. These regulatory processes ensure that products are safe and effective. National and regional agencies—including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national regulatory authorities in the developing world—manage regulatory processes.

Safe for widespread use?

Often, products must be reviewed and licensed by the national regulatory authority of the country in which they will be marketed and distributed. These authorities study whether a product is safe for widespread use and whether manufacturers can consistently produce high-quality products. Among the issues regulatory authorities consider are:

  • Whether the design for clinical testing is safe enough to warrant human participation.
  • Whether there is enough data to ascertain risks and benefits, and whether the benefits from any given product outweigh the risks that may be associated with its use.
  • Whether data collected in one country can be applied to the use of a product in another country.

After a product is approved, licensed, and marketed, it must be monitored to ensure that its benefit matches expectations.

Review in the developing world

Regulatory review of products designed for use in the developing world can be particularly challenging. To reflect local priorities and health conditions, regulatory review ideally is managed by the government or regional authority of the people for which the product has been designed. Challenges arise when regulatory authorities in developing countries do not have the skills and/or resources to manage the review. As additional products are developed for low-income countries, the strain on the agency’s resources may become even greater.

The FDA and other regulatory authorities can support these regulatory processes, ultimately ensuring that products reach those who need them most. Some mechanisms, such as the EMA’s Article 58 and the World Health Organization Prequalification Programme, help assure safety and efficacy of products designed exclusively for the developing world.

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