Responsilbilities in Outsourcing Clinical Testing

Editor’s note: C&T magazine’s regular Bench & Beyond columnist Bud Brewster welcomes guest contributor and consultant Theresa Callaghan, PhD, to this month’s space.

In the major markets of Japan, the United States and the European Union, cosmetic manufacturers always retain full responsibility for the safety of their products. In Canada, that responsibility also extends to efficacy. Manufacturers are required to conduct testing to provide proof of a product’s safety—and efficacy, in the Canadian market—and they must produce that proof when called upon to do so by the authorities.

In the United States, for example, while the Food, Drug and Cosmetic Act does not subject cosmetics to premarket approval by the Food and Drug Administration, the agency has consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products. It remains the responsibility of the manufacturer to substantiate the safety of both ingredients and finished cosmetic products prior to their being marketed.

Companies developing cosmetic products have three options available to meet this testing requirement: in-house facilities, universities and commercial testing laboratories such as clinical research organizations (CROs). Regardless of the testing option selected, the testers will need to develop new methods and expertise for delivering scientifically sound studies. Some examples of innovative test methods developed by CROs are described in Innovating at CROs.

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