WHY DID EMA STOP?

Background

EMA, the European Medicines Agency, is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use. EMA's decisions on marketing authorizations for medicines are valid throughout the European Union.

The Decision to Stop

In March 2020, EMA announced that it would be temporarily stopping its review of new marketing authorization applications (MAAs) for all medicines except for those treating COVID-19. This decision was made in order to focus the agency's resources on the urgent need to review and approve vaccines and treatments for the pandemic.

The decision to stop EMA was a difficult one, but it was necessary to ensure that the agency could continue to fulfill its mandate of protecting public health.

The Impact of the Decision

The decision to stop EMA has had a significant impact on the pharmaceutical industry.

Many companies have had to delay the launch of new products in Europe. This has led to lost revenue and job losses.

The Future of EMA

EMA has stated that it plans to resume its review of new MAAs as soon as possible. However, it is unclear when this will happen.

The agency is currently working on a plan to address the backlog of applications that has built up since March 2020.

In the meantime, the pharmaceutical industry is calling on EMA to take steps to mitigate the impact of the decision to stop.

Conclusion

The decision to stop EMA was a difficult one, but it was necessary to ensure that the agency could continue to fulfill its mandate of protecting public health.

The decision has had a significant impact on the pharmaceutical industry, but the agency is working on a plan to address the backlog of applications that has built up.

FAQs

1. Why did EMA stop reviewing new MAAs?
   EMA stopped reviewing new MAAs in order to focus its resources on the urgent need to review and approve vaccines and treatments for COVID-19.

2. When will EMA resume reviewing new MAAs?
   EMA plans to resume reviewing new MAAs as soon as possible, but it is unclear when this will happen.

3. What impact has the decision to stop EMA had on the pharmaceutical industry?
   The decision to stop EMA has had a significant impact on the pharmaceutical industry. Many companies have had to delay the launch of new products in Europe. This has led to lost revenue and job losses.

4. What is EMA doing to address the backlog of applications?
   EMA is currently working on a plan to address the backlog of applications that has built up since March 2020.

5. What can the pharmaceutical industry do to mitigate the impact of the decision to stop EMA?
   The pharmaceutical industry is calling on EMA to take steps to mitigate the impact of the decision to stop. Some of the steps that EMA could take include:

• Prioritizing the review of MAAs for medicines that are urgently needed.
• Increasing the number of staff dedicated to reviewing MAAs.
• Working with other regulatory agencies to share the workload.