Role of Pharmacopoeias in Medicinal Product Licensing at BfArM

Primary Standard: European Pharmacopoeia (Ph. Eur.)

The European Pharmacopoeia (Ph. Eur.), published by the European Directorate for the Quality of Medicines & HealthCare (EDQM), is the legally binding quality standard for medicinal substances and products in Germany and throughout the EU. Compliance with current Ph. Eur. monographs is mandatory for all relevant active substances, excipients, and finished products during marketing authorisation applications and post-authorisation variations. Pharmacopoeia - BfArM

BfArM enforces Ph. Eur. requirements in its assessments, including tests for identity, purity, assay, and impurities. Where a Ph. Eur. monograph exists, it takes precedence over other specifications unless justified otherwise with robust scientific data.

Supplementary Role of the German Pharmacopoeia (DAB)

The Deutsches Arzneibuch (DAB) serves as a national pharmacopoeia and contains monographs and general chapters not (yet) covered by the Ph. Eur. or where additional national requirements apply. DAB monographs remain relevant for certain herbal drugs, homeopathic preparations, and traditional herbal medicinal products authorised nationally in Germany. BfArM may require compliance with DAB where Ph. Eur. does not provide a monograph or where DAB specifies stricter or additional controls.

Legal and Practical Implications

• Marketing authorisation dossiers must demonstrate compliance with the latest valid Ph. Eur. (and DAB where applicable) at the time of submission.
• Updates to pharmacopoeial monographs may trigger variations (e.g., Type IB or II) if they affect specifications, test methods, or limits.
• BfArM accepts Ph. Eur. reference standards and encourages use of EDQM-certified reference materials for analytical controls.
• For non-monographed substances, applicants must justify their own specifications, often referencing Ph. Eur. general chapters.

Harmonisation and Updates

BfArM actively participates in EDQM expert groups and the European Pharmacopoeia Commission to contribute to monograph development and revision. Applicants are advised to monitor Ph. Eur. updates via the EDQM website and implement changes proactively to avoid compliance issues during authorisation or inspections.

Pharmacopoeial compliance ensures consistent quality across the EU, supports mutual recognition of authorisations, and protects public health by establishing harmonised standards for medicinal products evaluated and authorised by BfArM. Pharmacopoeia - BfArM