French Agency To Boost EU Role & Open Up To Outside World
France’s medicines and medical devices regulator wants to build up its role in the EU regulatory system, make its inner workings more accessible to stakeholders and the outside world, and improve the way it deals with medicine shortages.
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Tecentriq has become the second authorized medicine to be made available for an unapproved indication under modifications to France’s early access program. Patients with small cell lung cancer can now be given the product pending EU approval of its use in this condition.
The French Senate has produced a set of recommendations for tackling the growing problem of medicine shortages in France and the rest of Europe. The industry body Leem says shortages have many causes and that it will work with other stakeholders to find long-term solutions.
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances.