Regulatory Affairs Professionals Society

Euro Roundup: EMA sees slight improvement in approval submission predictability, reversing trend

The trend for the timing of initial marketing authorization applications (MAAs) to be less predictable is slowly reversing ...

EMA Webinar to Explore How AI-Driven Observability Connects IT Performance to Real Business Impact

Enterprise Management Associates (EMA™), a leading IT research and consulting firm, today announced it will host a webinar, ...
Regulatory Affairs Professionals Society

Euro Roundup: EMA, HMA recommend regulatory changes to address radiopharmaceutical challenges

European authorities have recommended changes to the regulatory framework to keep pace with the progress of the ...
STAT

Improving the FDA-EMA parallel scientific advice program to advance complex generics

Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics ...
PharmTech

EMA Calls New EU Pharma Legislation Most Significant in Two Decades

The reform grants eight years of regulatory data and market protection, with extensions for drugs addressing unmet needs. EMA's procedures will be streamlined, reducing assessment times and ...
PharmTech

EMA Prepared for Health Technology Assessment Regulation Implementation

The European Medicines Agency (EMA) announced on Jan. 10, 2025 that it is prepared for the implementation of the health technology assessment regulation (HTAR) that comes into effect on Jan. 12, 2025 ...