Objective: Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the fi rst biosimilar was approved in the European Union, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off -patent biologicals. Methods: The EBE survey was conducted among national pharmaceutical trade associations in 32 countries, the 28 EU Member States plus Norway, Serbia, Switzerland and Turkey. The questionnaire was a revised version of the previous survey of 2014 and was developed by the EBE Biosimilars Working Group. It contained 44 questions about eight policy areas: Availability of biological medicines, Tendering, Health Technology Assessment, International Nonproprietary Name prescribing, Internal Reference Pricing, Substitution, Interchangeability and Quotas. Results: Responses were received from all national trade associations contacted. According to the responses, the majority of the 32 countries surveyed have specifi c policies for off -patent biologicals in place and therefore take account of the specifi cities of biologicals. Nevertheless, variations exist and refl ect the responsibilities in healthcare policy-making in Europe. In the majority of countries, treatment decisions remain in the hands of physicians. Compared to the fi rst EBE survey, shifts have been seen in the areas of substitution and interchangeability. Conclusion: The second EBE survey on biological medicines policies indicates that nearly all jurisdictions have policies in place that refl ect the diff erent nature of biological medicines. However, policies and their implementation vary among diff erent jurisdictions.

The pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups. To this end, the European Medicines Agency worked with stakeholders to draft its Regulatory Science Strategy to 2025 and launched it for public consultation. The responses to this consultation were analyzed qualitatively, using framework analysis and quantitatively, to derive stakeholders' aggregate scores for the proposed recommendations. This paper provides a comprehensive resource of stakeholder positions on key regulatory science topics of the coming 5 years. These stakeholder positions have implications for the development and regulatory approval of both human and veterinary medicines.

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The current regulation of residues of antimicrobial veterinary medicinal products resulting from the treatment of food-producing animals in the European Union (EU) is reviewed and results of the application of the regulation are presented. European legislation concerning the control of residues of veterinary medicinal products requires the evaluation of antimicrobial properties of residues of such products. Three evaluation approaches are accepted: (i) human data, (ii) data to demonstrate no-observed-effect-levels obtained in gnotobiotic human gut ora associated (HFA) animals or (iii) the calculation of a microbiological acceptable daily intake (ADI) from in vitro minimum inhibition concentration (MIC) data. By September 1999, a total of 55 antimicrobial substances of 16 different classes were evaluated in the EU with respect to the safety of their residues to the consumer and for 46 of these the microbiological effects of their residues was assessed. In most instances (41 substances) in vitro MIC data were used for the evaluation and an arbitrary microbiological ADI was calculated. Suf cient human data were present only for tetracyclines (tetra-, chlortetra-, oxytetra-and doxycycline) and adequate data from gnotobiotic animals (human gut ora-associated rats or mice) were available only for tilmicosin. However, only for 39 of the 55 compounds the antimicrobial effects of residues were considered the most relevant for the overall safety assessment, while for 16 compounds of 5 different classes the toxicological effects were most relevant and their overall evaluation was based on a toxicological ADI. Key words: In uence on human gut ora, microbiological safety of residues, regulation, residues of veterinary medicinal products, review article, safety evaluation.