Regulation of Medicines by the European Medicines Agency (EMA)
Regulation of Medicines by the European Medicines Agency (EMA)
The European Medicines Agency (EMA) is the regulatory body of the European Union responsible for the scientific evaluation and supervision of medicines developed for
commercialization in the European market. Its operations are governed by Directive 2001/83/EC and Regulation 726/2004, which establish the requirements and procedures for drug authorization in the EU.
Drug Authorization Procedures
There are two main pathways to obtain a marketing authorization in Europe:
1. Centralized Authorization Procedure: Managed directly by the EMA and mandatory for certain innovative medicines.
2. National Authorization Procedures: Include decentralized and mutual recognition procedures, where national authorities conduct the assessment.
The EMA exclusively evaluates centralized procedures through its Committee for Medicinal Products for Human Use (CHMP), with support from the Pharmacovigilance Risk
Assessment Committee (PRAC), the Pediatric Committee (PDCO), and the Committee for Advanced Therapies (CAT). The evaluation takes up to 210 days, and the final decision is
issued by the European Commission.
Medicines Subject to Mandatory EMA Evaluation
The following medicines must undergo EMA evaluation:
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- Medicines for rare diseases (orphan drugs)
- Therapies for HIV, cancer, and neurodegenerative diseases
- Drugs for diabetes and autoimmune diseases
- Biotechnological medicines, gene therapy, and monoclonal antibodies
Steps of the Authorization Process
1. Eligibility Request: The applicant submits a justification for the centralized procedure.
2. Notification of Intent to Submit: The applicant informs the planned submission date.
3. Appointment of (Co)-Rapporteurs: Designation of expert evaluators.
4. Pre-Submission Meetings: Regulatory guidance sessions.
5. Submission of the Application: Done through the eSubmission platform in eCTD format.
6. Scientific Evaluation: Review by EMA committees.
7. European Commission Decision: Final approval or rejection of the drug.
Conclusion
The EMA's regulatory framework is essential to ensuring the safety, efficacy, and quality of
medicines in the European Union. Its rigorous scientific evaluation process facilitates access to
innovative treatments while maintaining high standards of oversight.
At SCR Consulting, we provide specialized advisory services to guide companies through the
regulatory requirements of the EMA and other international authorities, facilitating market
access in Europe with a strategic and efficient approach.