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The European Medicine Agency (EMA) released its annual report on Monday.

Key medicine outputs delivered in 2019 by EMA include;

  • 66 medicines received marketing authorisation and 4 medicines received negative opinions,
  • 60 extensions of indication were recommended,
  • 7 medicines with orphan medicine designation were recommended.

Agency developments in 2019

The agency had a year of upheaval as it relocated to the Netherlands and spent considerable resource on business continuity planning for Brexit.

Major pieces of legislation were implemented for medical devices. Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices will come into full effect in May 2020 and May 2022, respectively.

EMA opened a new Innovation Task Force (ITF), its platform for early dialogue to medicine developers. ITF identifies hurdles and offers support for the development of innovative therapies and technologies, for example on developing new antimicrobial agents.

EMA also neared completion of the development of its five-year EU Network Strategy to 2025.

Early access to medicines

EMA offers early access to medicines that target an unmet medical need or are of major public health interest. In 2019, this was provided to a small selection of medicine via three mechanisms;

  1. Accelerated assessment– three medicines (Ervebo®, Xospata®and Zynteglo®) were granted marketing authorisation following an accelerated assessment.
  2. Conditional marketing authorisation – eight medicines with less complete clinical data than normally required received an early conditional authorisation.
  3. Exceptional circumstance authorisation– one medicine (Dectova®, an antiviral medicine to treat influenza) was authorised under exceptional circumstances. This route provides patient access to medicines that cannot be approved under a standard authorisation as comprehensive data cannot be obtained.

The availability of early access to some medicines is encouraging, but is still a fraction of the overall medicines assessed. For example, since the introduction of conditional marketing authorisations in 2006, only 47 medicines have received the designation, which equates to fewer than 4 a year.

There is a demand from industry for greater inclusion on early access to medicine schemes – 11 medicines were rejected from the accelerated assessment process in 2019. The demand for early access is not unexpected given the lengthy standard review process; the average time required for assessment and adoption of a new medicine by the European Commission was 423 days in 2019.

Therefore, it seems EMA still has further progress to make on streamlining its processes and extending admission to its early access to medicines schemes.

For further insight on the annual report or on how the EMA’s work might affect your business, or if you would like to know more about Decideum, please feel free to contact us.

By Sebastian Guterres


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