1. EMA’s Role in Drug Approval & Regulation
- Centralised Procedure Management – EMA oversees the centralised marketing authorisation procedure, allowing a single drug approval for all EU Member States.
- Scientific & Regulatory Standards – Develops harmonized technical, procedural, and scientific guidelines for medicine development.
- Post-Marketing Surveillance – Monitors the safety and efficacy of approved medicines through pharmacovigilance systems.
- Scientific Advice & Innovation Support – Provides early regulatory guidance to companies developing innovative therapies.
2. EMA’s Scientific Committees & Their Responsibilities
The EMA’s regulatory decisions are guided by seven key scientific committees, each responsible for a specific area of medicinal evaluation:
Committee for Medicinal Products for Human Use (CHMP)
- Assesses marketing authorisation applications (MAAs) for human medicines.
- Assesses modifications and extensions to existing marketing authorisations.
- Provides scientific recommendations on drug efficacy and safety.
Pharmacovigilance Risk Assessment Committee (PRAC)
- Performs benefit-risk assessment of human medicines
- Evaluates and monitors adverse drug reactions (ADRs) and pharmacovigilance plans.
Committee for Medicinal Products for Veterinary Use (CVMP)
- Reviews and authorises medicines intended for animal health and veterinary use.
Committee for Orphan Medicinal Products (COMP)
- Assesses drugs designed for rare diseases to determine eligibility for orphan drug designation.
Committee on Herbal Medicinal Products (HMPC)
- Evaluates the quality, safety, and efficacy of herbal medicines.
Committee for Advanced Therapies (CAT)
- Assessment of quality, safety and efficacy of advanced medicinal products (ATMPs) before the final decision on the marketing authorisation is granted
- Specializes in gene therapy, cell therapy, and tissue-engineered medicines.
Paediatric Committee (PDCO)
- Ensures new medicines are appropriately tested for pediatric populations.
- Assessment of paediatric investigation plans (PIPs).
- Determines which studies a company must carry out in children.
Additional Advisory Groups & Working Parties
- Provide specialized scientific advice and regulatory support in areas like biosimilars, vaccines, and small molecule medicines.
3. EMA’s Role in Marketing Authorisation
- Centralized Procedure (CP) – the European Commission (EC) grants an EU-wide marketing authorisation through the CP based on EMA’s recommendation.
- EMA coordinates inspections connected to the assessment of marketing-authorisation applications.
- Post-Approval Monitoring and supervision of safety of medicines – Ensures compliance with Good Pharmacovigilance Practices (GVP)
- Develops guidelines and sets standards
Why EMA is Important
- Ensures Public Health Protection – Maintains high drug safety standards across Europe.
- Facilitates Market Access – Allows pharmaceutical companies to streamline drug approvals.
- Supports Innovation – Provides scientific guidance for novel therapies like ATMPs and biologics.