Centralised procedure (EU)

Centralised procedure (EU)
Name	Centralised procedure (EU)
Jurisdiction	European Union
Agency	European Medicines Agency
Created	1995

Centralised procedure (EU) The centralised procedure is an established regulatory route for obtaining a single marketing authorisation valid across the European Union, European Economic Area, European Commission, European Parliament and associated territories. It streamlines scientific assessment, harmonises standards from agencies such as the European Medicines Agency and national competent authorities like the Medicines and Healthcare products Regulatory Agency and Agence nationale de sécurité du médicament et des produits de santé. The procedure interrelates with legislation including the Directive 2001/83/EC, Regulation (EC) No 726/2004 and policy processes involving the Council of the European Union and the European Council.

Overview

The centralised route offers a unified pathway managed by the European Medicines Agency and decided by the European Commission, replacing separate filings to member state authorities such as Anvisa (note: non-EU comparator), Bundesinstitut für Arzneimittel und Medizinprodukte, AIFA and HAIFA. Originating from harmonisation initiatives like the Single European Act and successive pharmaceutical regulatory reforms, it supports innovation hubs tied to entities like European Federation of Pharmaceutical Industries and Associations, academic centres including University of Oxford and research networks such as European Clinical Research Infrastructure Network. The framework interacts with intellectual property regimes exemplified by the European Patent Convention and incentives under the Orphan Drug Regulation.

Scope and eligible medicines

Medicinal products for human use within the centralised remit include biotechnology-derived products from organisations such as Genentech and Novartis, advanced-therapy medicinal products associated with institutions like Cellectis and Sobi, and treatments addressing rare conditions under the Orphan Drug Regulation (EC) No 141/2000. It encompasses vaccines developed by companies like GlaxoSmithKline and Pfizer, antiviral agents referenced in work by European Centre for Disease Prevention and Control, and oncology agents investigated via consortia like European Organisation for Research and Treatment of Cancer. The scope is defined by Regulation (EC) No 726/2004 and covers selected antimicrobials, gene therapies cited in EMA scientific guidelines, and novel active substances championed by entities such as Novavax.

Application and evaluation process

Applicants submit a marketing-authorisation application to the European Medicines Agency, guided by procedural rules in International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use documents and dossiers prepared by sponsors such as AstraZeneca and Sanofi. The Committee for Medicinal Products for Human Use conducts a scientific assessment with rapporteurs drawn from national agencies like Agence Européenne de Médicament rapporteur examples and co-rapporteurs modelled on practices at Swedish Medical Products Agency. Timelines reflect milestones established by the European Commission and coordination with procedures used by agencies like the United States Food and Drug Administration in parallel scientific advice. The evaluation includes quality, safety and efficacy modules based on standards articulated by World Health Organization and technical guidance from European Directorate for the Quality of Medicines & HealthCare.

Role of the European Medicines Agency and Committee for Medicinal Products for Human Use

The European Medicines Agency organises the centralised assessment via the Committee for Medicinal Products for Human Use, which appoints rapporteurs from national competent authorities such as Medicines and Healthcare products Regulatory Agency and Bundesinstitut für Arzneimittel und Medizinprodukte. CHMP issues opinions drawing on input from scientific working parties, expert panels linked to European Network of Paediatric Research, and stakeholder consultations involving groups like European Patients' Academy on Therapeutic Innovation. Coordination with regulatory science initiatives such as European Medicines Regulatory Network ensures alignment with decisions by the European Commission and legal instruments including the Treaty on the Functioning of the European Union.

Decision-making and marketing authorisation outcome

Following a positive CHMP opinion, the European Commission adopts a legally binding marketing authorisation applicable in all European Union member states, with implementation overseen by national competent authorities such as AIFA and Agence nationale de sécurité du médicament et des produits de santé. Outcomes include full marketing authorisation, conditional marketing authorisation frequently used by developers like BioNTech during public health emergencies, and marketing authorisation under exceptional circumstances as employed in cases involving treatments for conditions referenced by European Centre for Disease Prevention and Control. Decisions may reference incentives from the Orphan Drug Regulation and interact with intellectual property frameworks like the European Patent Office.

Post-authorisation procedures and pharmacovigilance

Post-authorisation obligations are managed through pharmacovigilance systems coordinated between the European Medicines Agency, the European Pharmacovigilance Risk Assessment Committee and national agencies exemplified by Pharmacovigilance Programme of India (comparative model) and Medicines and Healthcare products Regulatory Agency. Risk management plans, periodic safety update reports and post-authorisation safety studies are implemented with input from academic partners such as Karolinska Institutet and consortia like European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Variations to the marketing authorisation follow procedures described by the European Commission and compliance is monitored by authorities including Court of Justice of the European Union where legal disputes arise.

Category:Pharmaceutical regulation