What is the EMA and what tasks does it fulfil?

28.10.2024

Question of the Week

The European Medicines Agency (EMA) has been responsible for the authorisation of innovative and biotechnologically manufactured medicinal products in a centralised procedure since 1995. Before finalising the assessment process, the responsible committee can have a GMP inspection carried out. In the mutual recognition authorisation procedure, the EMA has a mediating function in the event of differences of opinion between the Member States concerned.

[GMP Compliance Adviser, Chapter B.2]

Would you like to discover more?

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

09.01.2026

News

PIC/S: Jordan FDA Joins PIC/S

On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57^th PIC/S Participating Authority.

Swissmedic: Scientific GMDP Meetings

Swissmedic offers companies holding or seeking a Swissmedic manufacturing or distribution license the opportunity to discuss project-specific GMP and GDP topics in Scientific GMDP Meetings.

Purified Water – The new Chinese Pharmacopoeias and What Happens Next? NEU

A new Chinese Pharmacopoeia was published in 2025. This has some significant implications for the pharmaceutical water industry, which we will discuss in more detail in this article. Firstly, it is important to note that cold WFI systems are now permitted worldwide and can be used across the board.