Human regulatory: overview
Information on the regulation of medicines for human use in the European Union (EU), with a focus on the centralised procedure. The European Medicines Agency (EMA) plays a key role in this procedure.
Human medicines in the product lifecycle
Research and development
How to design and run clinical trials, compliance standards, and obligations and incentives for developers of specialised medicines
Marketing authorisation
Process and requirements for obtaining a centralised marketing authorisation that is valid in all EU Member States as well as in Iceland, Liechtenstein and Norway
Post-authorisation
Activities after a medicines has been authorised, including safety monitoring, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls
Some regulatory topics span the medicinal product lifecycle. This website offers an overview page for these topics, with links to relevant information in the product lifecycle stages.
Regulatory information on herbal medicines and medical devices is contained sperately, as these products are regulated differently in Europe.
For further information on EU legislation and procedures for the regulation of human medicines, see volumes 1-4 and 9-10 of the rules governing medicinal products in the EU.
Topics that span the product lifecycle
Advanced therapies
Innovative medicines based on genes, tissues or cells that are regulated under a specific legal farmework
Biosimilars
Biological medicines that are highly similar to another already approved biological medicine
Compliance
Standards that medicine developers, manufacturers and distributors must comply with
Data on medicines (ISO IDMP standards)
International standards to facilitate the reliable exchange of medicinal product information
Orphan designation
Medicines intended for use against a rare condition can be designated as orphan medicines to benefit from incentives
Paediatric medicines
Paediatric medicines development and the authorisation of medicines for use in children
Pharmacovigilance
The system for closely monitoring the safety and efficacy of medicines on the EU market
Plasma master file (PMF) certification
A PMF must be submitted for all products containing an active or inactive ingredient that is derived from human blood
Public health threats
EMA's efforts to protect public health, including regulatory measures during public health emergencies
Support for early access
Regulatory mechanisms to speed up patient access to important medicines
Topics A-Z
Accelerated assessmentAdaptive pathwaysAdvanced therapiesAntimicrobial resistance in human medicineBiosimilar medicinesClinical data publicationCompassionate useComplianceConditional marketing authorisationCoronavirus disease (COVID-19)Data submission on authorised medicines (Article 57)Ethical use of animals in medicine testingFalsified medicinesFeesGeneric and hybrid applicationsMedical devicesMedicines for older peopleMarketing authorisationMedicine shortages and availability issuesMedicines for use outside the European UnionOrphan designation: OverviewPaediatric medicines: OverviewParallel distributionPharmacovigilance: OverviewPharmacovigilance feesPlasma master file (PMF) certificationPre-authorisation guidancePost-authorisationPRIME: priority medicinesProduct-information requirementsPublic health threatsQuality defects and recallsReferral proceduresScientific guidelinesSupport for early accessSupport to SMEsProcedural timetablesTemplates for assessorsVariations for human medicines