Recent in Updates by Region (page 27 of 29)

FDA Commissions Study of its Drug, Biologics Application Processes

The U.S. Food and Drug Administration (FDA) released a new report that examines the way the agency reviews applications for drugs and biologics that have not previously been approved by the FDA.

Dermatology Association Urges FDA to Postpone Program for Isotretinoin Patients

Patient safety while taking isotretinoin depends on the careful oversight of the prescriber, according to the American Academy of Dermatology Association.

Foamix Awarded American, Australian Patents for Delivery Technology

Foamix Ltd. announced it has received two separate patents for its delivery system/carrier technology.

EU to Move Forward with Research Funding Program

The leaders of the European Union (EU) reportedly plan to move forward making a decision regarding the region's R&D funding program.

Regulatory Review--United States Update

California’s Safe Cosmetic Act Well, he did it. In October Governor Arnold Schwarzenegger signed into law the California Safe Cosmetic Act of 2005. As reported in my last column, this new law will not make cosmetics safer than they are now, but will increase costs for cosmetic companies and the taxpayers of the State of California while accomplishing absolutely nothing.

European Commission Approves Fentanyl HCl Iontophoretic Transdermal System

The European Commission has granted marketing authorization in the 25 member states of the European Union for the use of Fentanyl hydrochloride (HCl) Iontophoretic Transdermal System (ITS) 40 mcg/dose...

EUROPEN Publishes Packaging Standards Guide

EUROPEN has published a new edition of its guide to assist personal care manufacturers with packaging standards and regulations.

The 7th International Conference on Cosmetic Regulations

On October 20-22, 2003, more than 300 delegates gathered at the Le Meridien Grand Pacific Hotel on Tokyo Bay for the 7th International Conference on Cosmetic Regulations. Every three years, U.S., EU and Japanese trade associations for the cosmetic industry sponsor this meeting in order to gain mutual understanding and work toward harmonizing global regulations of cosmetics. There were no spectacular announcements, unlike the last conference in 2000 in Malta when Japan announced significant changes in their cosmetic regulations.

European Adaptation to Technical Progress

Starting with January 2003, The European Union discontinued the numbering of their Adaptation to Technical Progress (ATP). This was done as the 7th Amendment superceded some of the approved ATP’s and made the numbering system out of sync. Since I last reported on the 7th Amendment changes, the EU Commission has issued two critical changes. ATP’s are the way to change the Annexes in the Cosmetic Directive.

US and EU Regulations Update

United States – OTC Drug Review Call for Data On December 31, 2003, the FDA announced a call for data for an OTC drug review, for drugs that have not been reviewed as of this date. These include drugs sold before 5/11/72 (when the OTC drug review began) and identified by OTC category. Also included are OTC drugs marketed before 12/4/75 and described the DA’s general regulatory policy. The call for data covers these categories of ingredients, some of which have been considered to be cosmetics, not drugs: nasal moisturizer drug products, urinary analgesic/antiseptic drug products, urinary acidifiers and alkalinizers, aloe vera and urea, wrinkle remover products, lubricants and vaginal moisturizers.

Canada Updated

At the December 2003 Society of Cosmetic Chemists annual meeting, I presented a one-day session on international cosmetic regulations, and concluded by saying that 2004 would be the year of Canada. So far in 2004, three major changes have occurred.

Updates from Europe and the United States

European Updates The European Union (EU) Commission has not issued any changes to the Annexes of the Cosmetic Directive since September 2003 and lags in publishing many changes that have been approved. Adaptation to Technical Progress (opinions put through the EU and Ad Hoc committee review process) will be further delayed because they must be published in all EU languages. As of May 2004, the EU expanded from 15 to 25 countries, complicating the translation list.

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