Regulations

• UK Brexit - UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued (07/09/2020) a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.                                                                                              https://www.gov.uk/government/collections/mhra-post-transition-period-information                                                                  https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021  
• On 23 July an updated version of the Draft CTR Q&A (v2.4) was published on Eudralex-10: 

  https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf 

  Q&A 3.4 contains details about the submission of substantial modifications (SMs) and Art 81.9 non-SMs.
• European Commission working on proposal to postpone MDR application date for one year -https://ec.europa.eu/health/sites/health/files/docs/20200325_news_md_en.pdf
• REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
• REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)