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
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
2020 marks a further milestone in stricter controls on HCPs interactions in France. French government has laid the remaining bricks for the new (and stricter) regulatory framework for interactions between the industry and...more
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
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
On 19 January 2017, major modifications were adopted in France to the regulations on interactions between the industry and healthcare professionals (and other stakeholders). These new regulations, a.k.a. "anti-benefits...more