The European Medicines Agency in 2000 and 2015

20002015
Institutional locationDG EnterpriseDG Sanco
Financial support from industry€39m (71% of overall budget of €55m)9€251m (83% of €302m)10
Management board• 2 representatives per member state
• 2 representatives from the European Commission
• 2 representatives from the European Parliament
• 4 members representing all member states
• 4 representatives from the European Parliament
• 2 representatives from the European Commission (EC)
• 2 members representing industry (proposed by the EC)
• 1 member representing patients’ groups (proposed by the EC)
• 1 member representing doctors (proposed by the EC)
• 1 member representing social security schemes (proposed by the EC)
Committee for human medicinal products membership2 members per country, either independent experts or representatives of national drug agencies1 member per country, most often representative of national drug agencies
Committee for human medicinal products roles• Scientific advice,
• opinions,
• appeals, and
• arbitrations
• Scientific advice,
• opinions,
• appeals,
• arbitrations, and
• pharmacovigilance11 12
Evaluation criteria• Quality, safety, efficacy
• No comparative efficacy required (superiority v placebo and non-inferiority v active comparator allowed)
• Surrogate endpoints allowed
• No independent pivotal trial required
As in 2000
Summary of product characteristics• Prepared by industry
• Mostly meant to cover the gap of knowledge in the dossier
• Only reports on single products instead of classes of product with similar mechanisms of action and/or clinical indications
• Not a reliable and widespread source of information for physicians
As in 2000
Transparency• Withdrawals to avoid negative opinions
• Minority views not made public
• Drug dossier confidential
• Assessment process confidential
• Withdrawals cannot hide negative opinions any more
• Minority views made public
• Drug dossier mostly confidential, some data published
• Assessment process confidential
Approvals with reservations• Approvals under exceptional circumstances• Approvals under exceptional circumstances
• Conditional approvals
• Adaptive licensing
Mutual recognition proceduresA way out from the centralised procedures, which is mandatory for biotech products onlyBesides biotech products several other drugs must undergo the centralised procedure, including:
• anti-HIV/AIDS products,
• anticancer drugs,
• products for neurovegetative disorders,
• antidiabetic drugs,
• orphan drugs for rare diseases,
• treatments for autoimmune system diseases, and
• treatments for viral diseases
Renewal of marketing authorisationEvery five years, though mostly formalOnce only, after five years, then definitive
Complementary medicineHerbal and homeopathic products not to be assessedHerbal and homeopathic products to be assessed but to different standards from drugs