The process for obtaining an MA differs by region:
- In the European Union (EU) – This process is called a Marketing Authorisation Application (MAA) and is overseen by the European Medicines Agency (EMA) or national regulatory agencies.
- In the United States (U.S.) – It is called a New Drug Application (NDA) and is managed by the Food and Drug Administration (FDA).
1. Types of Marketing Authorisation Procedures in the EU
The pathway for obtaining an MA in the European Union (EU) depends on the type of procedure used:
Centralised Procedure (CP) – EMA Approval for All EU Countries
- Required for biotech, orphan drugs, and high-innovation medicines, medicines with a significant impact on public health
- Application submitted to the European Medicines Agency (EMA).
- Results in a single marketing authorisation valid in all EU Member States.
Decentralised Procedure (DCP) – Approval in Multiple EU States
- Used for medicines not covered by the Centralised Procedure.
- The application is submitted to multiple National Competent Authorities (NCAs) simultaneously.
Mutual Recognition Procedure (MRP) – Expansion of an Existing MA
- Used when a medicine already has a national authorisation in one EU country and the applicant seeks approval in others.
National Procedure – Country-Specific Approval
- Applied when authorisation is only needed in one EU Member State.
2. FDA vs. EMA Marketing Authorisation Process
EMA (European Medicines Agency) – EU
- Application Name: Marketing Authorisation Application (MAA)
- Regulating Body: EMA or National Competent Authorities
- Approval Scope: Centralised (EU-wide) or national options
- Review Process: Conducted by the Committee for Medicinal Products for Human Use (CHMP), leading to EU-wide approval
FDA (Food and Drug Administration) – U.S.
- Application Name: New Drug Application (NDA)
- Regulating Body: FDA (Center for Drug Evaluation and Research (CDER) for drugs, Center for Biologics Evaluation and Research (CBER) for biologics)
- Approval Scope: Limited to the U.S. only
- Review Process: FDA advisory committee review
3. Marketing Authorisation Validity & Renewal
- Initial MA Validity – An MA is granted for five years.
- Renewal Requirements – A renewal application must be submitted at least nine months before expiry to confirm the medicine’s ongoing safety and efficacy.
- Indefinite Authorisation – After the first renewal, the MA may become valid indefinitely unless additional periodic renewals are required.
4. Regulatory Compliance After Approval
Once an MA is granted, the MAH must:
- Submit Variations (Changes to the MA) – If manufacturing processes, indications, formulations change or if new information impacting the safety of the medicinal product becomes available.
- Maintain Pharmacovigilance Compliance – Report adverse drug reactions (ADRs) and periodic safety updates (PSURs).
- Ensure Good Manufacturing Practice (GMP) Compliance – Follow quality and safety standards in production.
Why a Marketing Authorisation is Important
- Demonstrates Drug Safety, Quality & Efficacy Before Market Entry.
- Harmonises Pharmaceutical Regulation Across Countries.
- Facilitates Global Drug Approval & Market Access.