PharSafer® is one of the leading Companies experienced in the Cosmetovigilance arena and with our 25+ years’ experience in post marketing drug safety, is appropriately placed to provide services to this new market.
In July 2013 new legislation came into play to regulate the cosmetic industry worldwide, in much the same way the pharmaceutical sector is regulated under the Pharmacovigilance banner.
Until then, the £200 billion global cosmetic industry had largely escaped formal regulation.
Unlike medicines, which are used to treat or prevent a disease in the body, cosmetics are not thought to change or affect the body’s structure or functions and as a result the requirement for Risk assessments and monitoring potential consumer harm has not been a priority. This means that the safety of cosmetic products are not reviewed or approved by national authorities before they are sold to the general public.
Also, there has not been the requirement to test the cosmetics in the same manner as medicines because of a perceived lack of effect or ‘danger’ perspective.
The identification and analysis of adverse reactions (serious undesirable effects (SUEs)), related to cosmetic products is a process which is still, currently and to a large extent, industry driven. It is the responsibility of manufacturers to determine that products and ingredients are safe before they are marketed and to then collect reports of adverse reactions.
On the 11th July 2013 this changed throughout Europe, and new global regulations are coming in to place, which will supersede the current cosmetics legislation, directing manufacturers and distributors to report serious undesirable effects to the appropriate authorities globally. These rules differ from country to country and PharSafer® has the rules for all of these countries, including how to collate data for the Product Information File (PIF), safety reviews, causality assessments, reporting and other areas of the legislation.
For more information on how PharSafer® can help cosmetic companies comply with the new Cosmetovigilance guidelines contact us.