EMA and FDA: Collaborative Parallel Scientific Advice

Parallel scientific advice, a cooperative approach between the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), streamlines drug development, benefiting patients and pharmaceutical companies alike.

Parallel advice offers:

• Efficiency: Companies gain insights from both agencies simultaneously, reducing the need for costly changes later.
• Resource Optimization: Avoiding redundancy saves time and money.
• Faster Access: Life-saving treatments reach patients more swiftly.
• Improved Trials: Robust clinical trial designs increase success rates.
• Global Impact: Promotes international cooperation and regulatory alignment.

The process involves:

• Request for Advice: Companies submit their plans and questions to both agencies.
• Joint Meeting: A meeting is held to discuss the proposal, resulting often in convergence in advice on approaches, full harmonization is not always possible.
• Efficient Development: Armed with insights, companies move forward confidently.

Challenges include regulatory differences and evolving medical products. Despite these hurdles, collaborative parallel scientific advice ensures that global drug development efforts remain harmonized and efficient, promising a brighter future for patients worldwide.

Starodub can assist with setting up you regulatory strategy. Please reach out to find out how we can help.