The following documents for human and veterinary medicines were also published:
date: 27/05/2024
- A new guideline for quantitative evidence synthesis on direct and indirect comparisons published by the Member State Coordination Group on health technology assessment (HTACG). It describes the methods currently available for direct and indirect treatment comparisons regarding the underlying assumptions, strengths and weaknesses in the context of joint clinical assessment of health technologies.
- A revised guideline ICH Q3C (R9) on ‘Impurities/Residual solvents’, updated on solvent volatility for analytical methods; came into effect on 29 April 2024.
- A new guideline on data requirements and rules for the determination of the need for a Maximum Residue Limit evaluation for chemical-unlike biological non-immunological substances used in veterinary medicinal products intended for use in food-producing species; will come into effect on 1 August 2024.
- A revised guideline on plasmid DNA vaccines for veterinary use addressing quality, safety and efficacy aspects of nucleic acid vaccines for use in animals; will come into effect on 17 July 2024. The update includes alignment with Regulation (EU) 2019/6 and additional clarifications resulting from experience gained from centrally authorised veterinary DNA vaccines.
- A revised guideline on environmental risk assessment (ERA) of human medicinal products, updated with guidance on risk and hazard assessment, reporting of findings and requirements for marketing authorisations; will come into effect on 1 September 2024.
- Questions and Answers on EU Good Manufacturing Practices and Good Distribution Practice updated on aspects related to manufacturing of sterile medicinal products and sampling of starting and packaging materials for human and veterinary medicines.