Regulatory Roundup for the Week of February 4, 2013

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The latest news from the pharmaceutical regulatory community.

FDA has releasedGuidance on Photosafety Evaluation of Pharmaceuticals S10, Step 2 Version (Nov. 13, 2012). This guidance recommends international standards for photosafety assessment, and harmonization of such assessments supporting human clinical trials and marketing authorization for pharmaceuticals.

In the effort to resolve the shortage of the cancer drug Doxil, FDA has approved the generic version of doxorubicin hydrochloride liposome injection, made by Sun Pharma Global FZE (Sun).

The European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare (MHLW) have launched a public consultation on a joint reflection paper on the development of block-copolymer-micelle medicinal products.


The United States Pharmacopeia has announced the formation of three new Expert Committees for its Medicines Compendium (MC) and an expanded and enhanced website for the online-only compendium in response to the need for global public quality standards for medicines.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a public health campaign in partnership with pharmacy organizations to promote the need for the public reporting of suspected side effects from drugs through MHRA’s Yellow Card Scheme.