Charting the life and times of the EMA as it leaves London

Established to coordinate, but not replace, the work of national medicines agencies in assessing medicines for authorisation, the EMA sets up headquarters in Canary Wharf, London. The European Commission (EC) makes the final decision regarding approval for use in the EU.

Before the EMA, for a drug to reach the entire EU market, a company had to submit separate applications to each country’s regulatory authority separately.

Funding to create the agency and its supporting advisory committees came from the EU itself, as well as industry partners and subsidies for member states.

1995 was also the year the EMA approved Gonal-F (follitropin-alfa), the first drug given the all clear for human use through the new, centralised authorisation method.

Gonal-F is an injectable biologic medicine created by Merck. It is indicated to treat a range of fertility problems in both women and men. It stimulates the maturing of eggs in women’s ovaries and treats men with a rare hormone deficiency disease, hypogonadotropic hypogonadism.

Previously, biologic medicines had been under the jurisdiction of the Biotechnology Working Party, which was integrated into the centralised EMA structure in 1995.

Initially the EMA’s remit focused on human and veterinary medicines and was supported by its core committees, the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use.

However, as specialised areas of medicines emerged and developed, the agency created a range of committees to assess new drugs from each new field. These included the Committee for Orphan Medicinal Products, which was created in 2000 to determine orphan drug designation reserved for products developed to treat rare, life-threatening conditions, as well as the Paediatric Committee and the Committee for Advanced Therapies (CAT), which were both established in 2007. The CAT assesses gene therapy, somatic cell therapy and tissue engineering products.

Discussions during the 2000s in the regulatory space regarding the impossibility of creating identical copies of biologic medicines led to the decision that once a biologic’s patent had expired, a copy simply needed to show it was similar in quality, safety and efficacy to the original, reference product.

This biologic copy was named a biosimilar; the EMA approved its first two biosimilar medicines in 2006: Omnitrope and Valtropin. Both of these contain the active ingredient somatropin and are indicated for children with growth failure, as well as adults with growth hormone deficiency.

Omnitrope is manufactured by Sandoz, while BioPartners holds the marketing authorisation for Valtropin.

Two years after the founding of the CAT, ChrondroCelect was the first advanced therapy approved by the EMA following the committee’s assessment.

Marketed by TiGenix, the therapy was created through tissue engineering and is used to repair single symptomatic cartilaginous damage to the cartilage in the knee caused by a defect to the femoral condyle cartilage.

Following a renewal of the authorisation in 2014, two years later the EC withdrew the marketing authorisation for ChrondroCelect after TiGenix notified the body that it was permanently discontinuing its marketing of the product for commercial reasons.

Although the main role of the EMA is linked to assessing medicines for use in the EU, sometimes it cooperates with the World Health Organization to use its regulatory procedure to evaluate medicines not marketed in the EU. The EMA sees this as enabling access to new medicines for patients with urgent need living in other parts of the world.

In July 2015, the EMA’s CHMP adopted a positive opinion of GlaxoSmithKline’s malaria vaccine Mosquirix, making it the first vaccine for malaria to be assessed by a regulatory agency.

Mosquirix provides short-term protection to children aged between six weeks and 17 months from malaria caused by the Plasmodium falciparum parasite. It works by inducing antibodies against malaria parasites in the blood or the liver.

Following the UK’s decision to leave the EU in June 2016 it is decided that since the EMA is required to be located in an EU member state, the EMA needed to find a new base.

The 27 member states of the EU had the opportunity to submit formal offers to host the agency, and Amsterdam was chosen as the location for the EMA’s headquarters from a list of 19 cities; other cities nominated included Milan, Copenhagen and Barcelona. This decision was informed by EC advice and a survey of EMA staff preferences.

Following in the footsteps of the US Food and Drug Administration, the EMA approved its first two CAR-T therapies for use in the EU to treat certain blood cancers. These were also the first medicines supported through the EMA’s newly launched priority medicines scheme.

The two advanced, gene therapies are Gilead’s Yescarta and Novartis’ Kymriah. Yescarta is indicated for diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma. Kymriah is also approved for DLBCL, in addition to B-cell acute lymphoblastic leukaemia.

CAT chair Dr Martina Schüssler-Lenz wrote in a statement: “CAR-T cells transform the fight against serious and often fatal diseases in the EU. Kymriah and Yescarta offer an innovative approach where patients' cells are reprogrammed and reinjected to attack the cancer.”

At the end of January 2019, the EMA initiated its official relocation from London to Amsterdam by lowering the 28 EU flags flying outside of its offices.

On 1 March, the agency officially left its London premises and began moving its staff to a temporary building in Amsterdam. The agency’s final move into its new, permanent headquarters is expected by the end of this year.

Wellcome Trust director Jeremey Farrar tweeted it was “a very sad day for the UK,” but “a great day for the Netherlands – good luck to the EMA.”