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Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics
The content of section 5.1 (“Pharmacodynamic properties”) of the Summary of Product Characteristics (SmPC) is proposed by the applicant or marketing authorisation holder and it is assessed by the rapporteur/s. The final content is discussed by the Committee for Human...
Good manufacturing practice (GMP) Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)
The objective of this workshop was therefore to gather structured, experience-based input from industry on the control, governance, and mitigation measures applied throughout the AI system lifecycle, with particular emphasis on the application of ICH Q9 quality risk...
PIC/S PE 009-18 – Guide to GMP for Medicinal Products | Part I
Guideline published on: 24/09/2026 Good Manufacturing Practice (GMP) provides the foundation for ensuring that medicinal products are consistently manufactured and controlled according to appropriate quality standards.
EMA Updates Information Page on Bioequivalence Guidelines
On 25 January 2025, the date of coming into effect, ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms supersedes applicable parts of this EMA guideline related to bioequivalence study considerations and data analysis for a...
Comprometidos com a qualidade e a inovação.
