Challenges Bringing Drugs to All EU Member States Worry Pharma
As the European Commission prepares for a major revamp to drug legislation, pharma executives and thought leaders worry that even with the new laws, rolling out new drugs to all 27 member states in a short timeframe will be a difficult task to achieve. The proposed law would offer pharma companies an additional years of data protection if new drugs reach all EU markets within 2-3 years of launch, which will be complicated if reimbursement decisions must be made in that period.
European Commission Reveals Plans for Single Market
Despite having region-level drug approval agencies like the European Medicines Agency (EMA), member states have their own approval agencies. This fragmented framework slows the rollout of new pharmaceuticals. To address this issue, the European Commission has released their plans to unify the approval process across all member states.
EU Preps for Drug Law Overhaul
The EU is preparing legislation that would overhaul the pharmaceutical industry with a series of reforms targeting drug prices, transparency, and intellectual property (IP). Under the legislation, drugmakers would have a reduced exclusivity period for new drugs, which can be ameliorated by launching a drug in all member states simultaneously. In addition, the laws would simplify the regulatory approval process.
Gilead Science’s Long-Acting HIV Drug Secures Win With EU Approval
Gilead Science has received approval from the European Commission for its HIV drug lenacapavir. The medication is used to treat multi-drug resistant HIV and is injected once every six months. This approval marks a win for Gilead, as the drug was placed on a temporary clinical by the FDA over the risk of contamination from glass shards.
EFPIA-EURORDIS Publishes Joint Statement on Patient Access to Rare Disease Medicines
The European Federation of Pharmaceutical Industries and a Associations has issued a joint statement with EURODIS Rare Diseases Europe on [...]
Pharma Facing Pressure to Renegotiate COVID-19 Vaccine Contracts with EU Govts
As the demand for COVID-19 vaccines dwindle in Europe, many EU nations’ governments look to renegotiate their vaccine deals [...]
Drugmakers Commit to Reducing Drug Launch Times in the EU
Members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) have pledged to file for pricing and reimbursement in [...]
Xcenda Explores the EU’s Transition To a Joint HTA Assessment Framework
The EU began its transition to a pan-European health technology assessment (HTA) framework this January. Xcenda covers this process in [...]
EU Joint Clinical Assessment for Drugs and Medical Devices on the Horizon
The EU has begun its transition to pan-European joint clinical assessment. The move will replace the current system of [...]
The Medical Affairs Role Receives a Makeover in Europe
The new MedTech regulatory environment in Europe is providing exciting new opportunities for the evolution of the Medical Affairs function, [...]
The European Medicines Agency (EMA) Seeks to Develop Sentinel-Style RWD Database
The European Medicines Agency is soliciting input from organizations interested in developing, operating, and maintaining a healthcare data analysis platform [...]
Germany’s Experiment With Drug Price Regulation: Aligning Clinical Benefit With Cost of Cancer Drugs
According to a new study, Germany’s move to reform pharmaceutical spending has resulted in closer alignment between clinical benefit and [...]
Report: European Drug Regulatory Network Faces Uncertain, Complex Future
A new strategy produced by European regulators considers future challenges for the European drug regulatory network, The Pink Sheet reports. [...]
