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Registrar Unveils Software To Assist MoCRA Stakeholders In Filing Adverse Event Reports

 
• By Eileen Francis

Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products globally, transmits information to internal stakeholders and formats serious events to the FDA Medwatch format for submission.

Adverse Event

Regulatory consultancy firm Registrar Corp. has launched Adverse Event Management (AEM) Software to assist cosmetic companies as they seek to comply with serious adverse event reporting requirements under the Modernization of Cosmetics Regulation Act.

Noting in a 23 July release that many cosmetic companies are ill-prepared for FDA’s new adverse event requirements, the Hampton,...

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More from Regulation

EU Proposal To Simplify Hazardous Chemical Rules For Cosmetics ‘Step In Right Direction’ - Industry

 
• By Eileen Francis

The European Commission’s Simplification Omnibus published July 8 is ‘step in right direction’ for streamlining processes and providing more legal certainty and predictability for regulations addressing cosmetics, says Cosmetics Europe.

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
• By Eileen Francis

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.

MoCRA Implementation Delay Creates More Legal Exposure For Stakeholders – Attorney

 
• By Eileen Francis

The delay in implementation of MoCRA is seen by many companies as a temporary reprieve, but it does create more legal uncertainty, says attorney Marissa Alkhazov of law firm Buchalter.

More from Policy & Regulation

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
• By Eileen Francis

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.

Cosmetics Europe Pushes Commission To Lower Industry’s UWWTD Costs

 
• By Lauren Nardella

The European Commission plans to conduct an updated study that could reallocate extended producer responsibility costs under its Urban Wastewater Treatment Directive, a step welcomed by industry after an analysis concludes the directive vastly overestimates cosmetics’ contribution to toxic waste.