EMA Communications

• The EU CTR Q&A has been updated (28 February 2021):                                                                            https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf

  (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.pdf;                                                                                                                                                          - Lessons_learned_summary_slide.pdf
• 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 -                                        https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-may-2020_en.pdf
• EMA consultation: Q3C (R8): Impurities: guideline for residual solvents (8 May 2020) -https://www.ema.europa.eu/en/documents/scientific-guideline/q3c-r8-step-2b-impurities-guideline-residual-solvents-pde-2-methyltetrahydrofuran-cyclopentyl-methyl_en.pdf
• EMA communication: EMA warns against using unproven cell-based therapies (29 April 2020) -                                                               https://www.ema.europa.eu/en/documents/public-statement/ema-warns-against-using-unproven-cell-based-therapies_en.pdf
• EMA publication: "Mandate, objectives and rules of procedure of the COVID-19 EMA pandemic Task Force (COVID-ETF)" (9 April 2020) -https://www.ema.europa.eu/en/documents/other/mandate-objectives-rules-procedure-covid-19-ema-pandemic-task-force-covid-etf_en.pdf
• EMA Press Release: "Global regulators stress need for robust evidence on COVID-19 treatments" (9 April 2020) -https://www.ema.europa.eu/en/news/global-regulators-stress-need-robust-evidence-covid-19-treatments
• EMA Consultation: "Call for scientific data for the periodic review of herbal monographs" (7 April 2020) -EMA_Consultation__Call_for_scientific_data_for_the_periodic_review_of_herbal_monographs.pdf
• EMA Communication: "COVID-19 - Update on treatment and vaccines under development and information on chloroquine and hydroxychloroquine (1 April 2020) -                                                                                                                                                                                                                                                                Update on treatments and vaccines against COVID-19 under development  //                                                                                                                                      COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
• EMA Communication: "EMA Regulatory Science to 2025" -                                                                                                               https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf
• "No change to product information for breast cancer medicine Tyverb following re-assessment of data" -                                                                  https://www.ema.europa.eu/en/news/no-change-product-information-breast-cancer-medicine-tyverb-following-re-assessment-data
• "Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic" - 

  https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

• "EC/EMA notice to stakeholders and EMA practical guidance" -                                                                          https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en.pdf  ///                                                                                                                                            https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/practical-guidance-procedures-related-brexit-medicinal-products-human-veterinary-use-within_en.pdf
• "EMA communication: Highlights of patient, consumer, and healthcare professional activities in 2019" - https://www.ema.europa.eu/en/documents/leaflet/public-engagement-highlights-2019_en.pdf
• "EMA communication: COVID-19: developers of medicines or vaccines to benefit from free scientific advice" -                                                             https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance
• "EMA communication: "Human Medicines Highlights" Newsletter - March 2020 issue" -                                                                                        https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-march-2020_en.pdf
• "EMA communication: Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU" -                                            novel coronavirus disease (COVID-19)
• "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" -                                                                                                                                                                                                                      https://www.ema.europa.eu/en/medicines/human/referrals/panexcell
• "EMA communication: CHMP has started a review of the cancer medicine Yondelis (trabectedin) used to treat ovarian cancer" - 
  https://www.ema.europa.eu/en/medicines/human/referrals/yondelis