Cosmetovigilance – Regulatory requirements & compliance through LifeSphere Safety MultiVigilance (ARISg)

Nov 17, 2016

With an increased focus on cosmetovigilance driven by regulatory agencies across countries, the safety departments need to understand the impact of these regulations, the general cosmetovigilance process and ensure compliance. Under the new EU Regulation (EC) No 1223/2009, cosmetic companies are required to have information clearly available to the Regulatory Authorities concerning their cosmetic products formulation as well as safety assessments of those products, derived from the reports received from Consumers, Health Care Professionals, Aesthetic Professionals, National Competent Authorities and the scientific literature. In the US, FDA cosmetovigilance monitors the safety of cosmetic products that are being marketed and acts on products that are established to be harmful to consumers when used as intended. The agency has a number of ways to monitor these products including Voluntary Cosmetic Registration Program (VCRP), Inspections, Product Surveys, Cosmetic Ingredient Review (CIR) expert panel and Reports from consumers and health care providers. In Japan, Article 7 of the Ministerial Ordinance on Good Vigilance Practice (GVP) for drugs, quasi-drugs, cosmetics, and medical devices (GVP Ordinance) stipulates the obligation of MAHs to collect safety information and its scope.

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ArisGlobal is transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary Nava® cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture.

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Alberto Cantor
ArisGlobal
+1 609-360-4042 | acantor@arisglobal.com