In this article by our pharmaceutical interpreters and GMP translators, you will learn interesting facts about the history of the EMA, the European Medicines Agency. What are the advantages of the EU authority for the member states? Find out in the following blog post.

The European Medicines Agency (EMA) is the European Union's medicines authority and is responsible for the central authorisation and monitoring of medicines in the EU. The agency was founded in 1995 under its former name, the European Medicines Evaluation Agency, or EMEA for short. It is responsible for both human and animal drugs and is home to seven scientific committees.

Advantages of the EMA: A centralised authorisation procedure

The EMA works together with a network of European national regulatory authorities and the European Commission. If a pharmaceutical company wants to launch a drug on the market in the EU, there are various authorisation procedures to choose from. The centralised procedure is used most frequently. This makes it possible to obtain marketing authorisation for all EU (and EEA) member states with just one application. Once the application has been submitted in full, it is reviewed by the Committee for Medicinal Products for Human Use (CHMP) with regard to quality, efficacy and safety. The CHMP then provides a scientific assessment. Representatives of all national medicines authorities of the EU member states and the EEA countries Iceland and Norway sit on this committee. This ensures that all countries are involved in the assessment of the medicinal products, with two member states always acting as rapporteur or co-rapporteur for each application and preparing the report, which is then discussed by the other representatives of the national medicine authorities. The marketing authorisation is then formally granted by the European Commission, which usually follows the recommendation of the CHMP.

The EMA and Brexit - relocation to Amsterdam and consequences for the authorisation of medicinal products

In the course of the United Kingdom's withdrawal from the European Union, the EMA's headquarters, which were located in London before Brexit, also had to be relocated. Several European cities competed for the new location, but Amsterdam was ultimately chosen, not least because of its central location and good accessibility. Since 2019, the EMA has therefore been based on the European mainland. In the British Isles, the MHRA (Medicines & Healthcare products Regulatory Agency) is now solely responsible for the authorisation of new medicinal products. However, the authority continues to rely on the EMA to a certain extent: Since 1 January 2024, the International Recognition Procedure (IRP) has been in force, which allows the UK authority to recognise marketing authorisations from other pharmaceutical authorities. This regulation applies to medicinal products that are already authorised in the EU, Australia, Canada, Japan, Singapore, Switzerland and the USA and replaces the previous European Commission Decision Reliance Procedure (ECDRP). However, applications can also be rejected under certain circumstances if the authority deems this necessary, e.g. due to insufficient data.

Following Brexit, the EMA distributed the tasks of the MHRA to the remaining national authorisation authorities. Thanks to the Northern Ireland Protocol, EU pharmaceutical legislation continues to apply in Northern Ireland.

Pharmaceutical interpreters for your Russian- or English-language GMP inspection

The EMA covers the entire European Union market with its centralised authorisation procedure. However, if a pharmaceutical company wants to market its products in Russia or the USA, for example, GMP inspections by the authorities in the respective country are required. These inspections are carried out in the language of the authority, i.e. in English in the case of the FDA and in Russian in the case of the SID&GP. As pharmaceutical interpreters and GMP translators, we provide you with reliable and competent support and ensure flawless communication between the inspector team and your staff at the local site. We are available throughout Europe and will be happy to provide you with a quote for our interpreting services.

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