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Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?

In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more

View from the Horizon: Pricing and financial regulation of health products in France

On June 27 the third edition of our new global series, Life Sciences and Health Care Horizons, took place in Paris with discussions focused on the pricing and financial regulation of health products after the latest reforms....more

The French Competition Authority Wants to Lower Prices of Pharmaceuticals

On November 21, 2017, the French Competition Authority (“FCA”) announced the launch of a new sector inquiry relating to the functioning of competition in the pharmaceutical sector....more

The French Competition Authority wants to lower prices of pharmaceuticals

On November 21, 2017, the French Competition Authority ("FCA") announced the launch of a new sector inquiry relating to the functioning of competition in the pharmaceutical sector....more

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