EMA Communications

• The EU CTR Q&A has been updated (28 February 2021).
  (Amongst updates to existing or new question added also includes: Appendix III: Matrix with examples what is SM, NSM art. 81.9. or NSM).
• Achievements made in the CTIS eLearning development in the last 2 months (21 February 2021):
  • CTIS training – Information note
  • Lessons learned summary slide
• EMA consultation: Guideline on the clinical evaluation of anticancer medicinal products (Rev 6) (17 November 2020):
  • Guideline on the clinical evaluation of anticancer medicinal products
  • Appendix 3 to the Guideline on the clinical evaluation of anticancer medicinal products
• EMA communication: “Human Medicines Highlights” Newsletter – May 2020 issue
• EMA consultation: Q3C (R8): Impurities: guideline for residual solvents (8 May 2020)
• EMA communication: EMA warns against using unproven cell-based therapies (29 April 2020)
• EMA publication: “Mandate, objectives and rules of procedure of the COVID-19 EMA pandemic Task Force (COVID-ETF)” (9 April 2020)
• EMA Press Release: “Global regulators stress need for robust evidence on COVID-19 treatments” (9 April 2020)
• EMA Consultation: “Call for scientific data for the periodic review of herbal monographs” (7 April 2020)
• EMA Communication: “COVID-19 – Update on treatment and vaccines under development and information on chloroquine and hydroxychloroquine” (1 April 2020) – COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
• EMA Communication: “EMA Regulatory Science to 2025”
• “No change to product information for breast cancer medicine Tyverb following re-assessment of data”
• “Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic”
• “EC/EMA notice to stakeholders and EMA practical guidance”:
  • WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES FOR MEDICINAL PRODUCTS FOR HUMAN USE AND VETERINARY MEDICINAL PRODUCTS
  • Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
• “EMA communication: Highlights of patient, consumer, and healthcare professional activities in 2019”
• “EMA communication: COVID-19: developers of medicines or vaccines to benefit from free scientific advice”
• “EMA communication: “Human Medicines Highlights” Newsletter – March 2020 issue”
• “EMA communication: Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU” 
• “EMA communication: Start of review of medicines for which studies have been conducted by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India”
• “EMA communication: CHMP has started a review of the cancer medicine Yondelis (trabectedin) used to treat ovarian cancer”