EU and US complete GMP harmonisation process
The FDA and EMA have completed implementation of their mutual recognition agreement for GMP inspection, with Slovakia being recognised by … read more »
EFPIA responds to EMA consultation on Regulatory Science Strategy
EFPIA has released its response to an EMA consultation, calling for support for innovation in clinical trials, improvement in regulatory … read more »
Germany to benefit from EU-US mutual recognition agreement for GMP inspections
Germany has been added to the list of EU member states able to approve GMP compliance within the mutual GMP … read more »
European bodies launch further push for publication of clinical trial results
The European Medicines Agency has called for improved publication rates for clinical trials, with 5,855 of a possible 18,432 as … read more »
EMA commits to strengthening interaction with three European primary care bodies
The EMA has signed a joint statement strengthening its interaction with three professional bodies representing primary care. The European Medicines … read more »
Combination Products: EMA to release Draft Guidelines concerning Article 117 MDR requirements
Products that contain both medicinal products and medical devices pose regulatory challenges, and the EMA plans to consult on the … read more »
EMA Publishes 2018 Annual Report
The European Medicines Agency (EMA) has published its Annual Report for 2018, highlighting the successes of the Agency over the … read more »
Regulators Can Add Value to Novel Treatments Through “Evidence by Design”
Regulators can help in the assessment of added therapeutic benefit of novel therapies by explicit reasoning and “evidence by design” … read more »
Regulators Can Add Value to Novel Treatments Through “Evidence by Design”
Regulators can help in the assessment of added therapeutic benefit of novel therapies by explicit reasoning and “evidence by design” … read more »
EMA Management Board March 2019 Meeting: Key Takeaways
The European Medicines Agency (EMA) Management Board has held its first meeting in its new premises in Amsterdam, and under … read more »
