EMA Annual Report published

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The recently published EMA Annual Report 2021 gives a good overview of the Agency's activities in its first chapter. The past year was also marked by measures in connection with the management of the COVID 19 pandemic, work related to the scientific assessment and supervision of medicines in the EU. In addition to these points, the report also contains an interesting selection of key figures and other important milestones.

For example, the EMA recommended four vaccines and five treatments for COVID-19 for marketing authorisation in the EU and also supported the expansion of vaccine manufacturing capacity.

Independent of the pandemic, the EMA recommended 92 medicines for human use for marketing authorisation, 54 of which had a new active ingredient (not previously authorised in the EU). This is an increase of 38% compared to 2020 and the highest number in the last five years. The EMA also recommended 12 veterinary medicines for marketing authorisation.

In addition, the report describes how the EMA has prepared for the implementation of the Veterinary Medicines Regulation and for the introduction of the new Clinical Trials Information System (CTIS).

EMA's role in crisis preparedness and medicines & medical device management

In light of EMA's experience in managing the pandemic-related crisis, the EU institutions have taken the first steps to expand EMA's role in crisis preparedness and management of medicines and medical devices. In the future, the EMA will also monitor and mitigate shortages of medicines and medical devices.

Other activities described are:

• Efforts to combat the threat of antibiotics to public health.
• Activities to strengthen IT security following a cyber attack on the EMA in December 2020.
• Initiatives on digital transformation
• Projects to strengthen scientific advice for products under development, support regulatory assessments and introduce new data analysis methods and tools

GMP inspections

The second chapter of the report is dedicated to key statistics and trends, such as GMP inspections:

The number of requests for a GMP inspection under the centralised authorisation procedure has increased by 117% compared to 2020. Five GMP inspections carried out by EEA authorities resulted in the issuing of a non-compliance statement. This means that medicinal products manufactured at a site with such a non-compliance statement cannot be sold in the EU. The EEA authorities also issued two declarations of non-compliance with GMP in relation to CAPs (centrally authorised products); either in relation to the active substance or the finished product.