News briefs: February 2006

Published: 1-Feb-2006


The European Medicines Agency (EMEA) has opened a special unit tasked with helping small and medium-sized pharmaceutical companies with the bureaucratic procedures required to secure EU market approvals for their medicines. Its experts would assist product information document translations, plus advise on authorisation rules and available EMEA fee reductions for smaller businesses.

Safety advice for EU consumers of the influenza medicine Tamiflu has been left unchanged by EMEA following a review of possible harmful psychological effects. Furthermore, EMEA's committee for human medicinal products has extended Tamiflu's approved uses for 1-13-year-olds from treating influenza to include prevention.

EMEA has issued a software tool to help companies wanting to submit proposed product information (PIM) labelling for screening.

EMEA has also issued guidance on non-clinical testing regarding gene transfer medicinal products.

Meanwhile, the European Commission is consulting on new draft pharmacovigilance guidelines for human medicines. (Alternative link).

It is also consulting on a draft guideline on extended marketing protection.

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