Regulatory Roundup: EMA Releases Genetic Variability Guideline

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EMA Releases Genetic Variability Guideline.

EMA has released a guideline on how to integrate studying the role of genetic variability between patients during the development of medicines. The guideline, effective August 2012, clarifies the requirements for the analysis of the effect of genetic variability on the way the human body handles medicines. The guideline addresses when pharmacogenetic studies should be performed, how these studies should be designed and carried out, how the clinical impact of genetic differences between patients should be evaluated, how dosing or treatment recommendations for genetic subpopulations should be studied, consequences for treatment recommendations and labeling, and the impact of interactions between medicines and of impaired or immature organ function.

The US Pharmacopeia is bringing together regulators, manufacturers, and other stakeholders in global public health for the 11th IPC-USP Science & Standards Symposium on February 22–23 in Mumbai. This year’s Symposium will focus on two important areas for India’s pharmaceutical sector-global quality standards for biologic medicines and supply chain management, according to USP. “The meeting is part of a continuing USP effort with the government of India generally and the IPC specifically to promote access to good quality medicines-not only those being exported but also those intended for the people of India,” says a USP press release on the meeting. For details, visit the USP registration site.