Building Trust and Efficiency: The New Reliance Trial in Pharmaceutical Approvals


Building Trust and Efficiency: The New Reliance Trial in Pharmaceutical Approvals

Well, let's talk about Reliance with this new study that has come to light. Basically, the World Health Organization (WHO) wants to ensure that people worldwide can access safe and effective medical products without delays. They think (and at FIFARMA we agree) that one way to do this is by getting different regions to trust the assessments other countries make on these products. 

Instead of each country conducting its own thorough review, they encourage trust in the assessment made by a trusted regulatory authority, such as the European Medicines Agency (EMA).

Right now, this isn't happening as much as we'd like, especially for certain types of approvals. That's why they're testing something new with a multinational biotechnology company. This company is testing a system where many countries agree to use a shorter approval process based on what a trusted authority, like the EMA, has already approved.

For example, a multinational biotechnology company made a big change in how it manufactures a specific drug. Instead of each country reviewing this change separately, they sent it to 48 countries at the same time, all of whom agreed to be part of this trial. These countries are supposed to study what the EMA has already reviewed and decide if they also agree, within a set deadline.

To ensure everyone is on the same page, the company shared all EMA information with these countries. They also established a system where any questions the countries have during their review process are answered and shared with all involved. This way, everyone knows what's going on and can make decisions more quickly.

The main goal of this trial is to make the approval process for changes in medications faster and less complicated globally. The company hopes to reduce the time it takes for approval from around 2.5 years to just 6.5 months. They also want to build trust with the important people involved and make it easier for different countries to reach an agreement on what's needed for approval, without each country having its own specific requirements.

It's an innovative strategy that streamlines the drug approval process by basing it on regulatory decisions made in other regions of the world, thus facilitating faster access to vital treatments.

This is a significant step towards ensuring a continuous supply of essential medicines and promoting global regulatory convergence as an example for our region! I hope the topic has sparked interest and helps you understand why Reliance involves all of us.



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