The European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is biological medicine that is highly similar in all essential aspects to a ‘reference’ biological medicine already authorised.
- MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
- VAGAS ESGOTADAS para a formação PROMOTIONAL REVIEW
- MDCG 2021-6 Questions & Answers regarding Clinical Investigations
- Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
- NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION.
- MDR/IVDR: Commission adopts new standardization request
- Relatórios de avaliação para efeitos de financiamento público agora disponíveis na Infomed
- Publicadas as Regras, requisitos e procedimentos para o licenciamento das atividades relacionadas com a planta da canábis para fins medicinais