Tower Mains Weekly Newsletter
MHRA updates its list of investigations and decisions carried out on advertising of medicines
On 27th August 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) published advertising investigations from April, May, and June 2021.
HMA/EMA Big Data Task Force releases its workplan 2021-2023
On 27th August 2021, the Big Data Task Force, set up by the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published its workplan 2021-2023. The implementation of the workplan will be flexible and certain actions may be re-scheduled, since the European medicines regulatory network must prioritise the unprecedented public health challenge of the COVID-19 pandemic.
FDA releases guidance on the conduct of clinical trials of medical products during COVID-19 pandemic
On 30th August, the U.S. Food and Drug Administration (FDA) released guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic. The FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimising risks to trial integrity for the duration of the pandemic.
WHO releases compendium of innovative health technologies for COVID-19 and other priority diseases
On 31st August 2021, the World Health Organisation (WHO) released a compendium of 24 new innovative health technologies for COVID-19 and other priority diseases. The compendium provides a full assessment of the technologies, carried out by a group of international experts working with WHO technical teams, based on compliance with WHO specifications regarding performance, quality, and safety; suitability in low-resource settings; affordability; ease of use; and regulatory approval status. This information is vital to help governments, non-governmental organisations and funders decide which products to procure.
European Commission announces stakeholder consultation on the amendments to IR (EU) 520/2012
On 1st September 2021, the European Commission released information on its targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities. While this consultation primarily seeks the stakeholders’ feedback on those proposed amendments, the Commission welcomes any additional remarks that could improve the application of the IR. The consultation will run until the 15th of October 2021.
Health Canada warns ivermectin is not authorised to prevent or treat COVID-19
Following concerning reports of the use of veterinary ivermectin to prevent or treat COVID-19, Health Canada is advising Canadians not to use either the veterinary or human drug versions of Ivermectin to prevent or treat COVID-19. There is no evidence that ivermectin in either formulation is safe or effective when used for those purposes. The human version of ivermectin is authorised for sale in Canada only for the treatment of parasitic worm infections in people. The veterinary version of ivermectin, especially at high doses, can be dangerous for humans and may cause serious health problems.
MHRA announces the appointment of four Non-Executive Directors
On 1st September 2021, the MHRA announced that Dr Junaid Bajwa, Professor Graham Cooke, Dr Paul Goldsmith and Raj Long have been appointed as Non-Executive Directors for the next three years. Their terms will come into effect from 1st September 2021 to replace Dr Barbara Bannister MBE, Professor Bruce Campbell, Anne-Toni Rodgers, and Professor David Webb CBE whose terms all came to an end on 31 August 2021.
WHO opens hub for pandemic and epidemic intelligence in Berlin
On 1st September 2021, it was announced that the WHO will open a hub for pandemic and epidemic intelligence in Berlin. The hub is part of the WHO’s Health Emergencies Programme and will be a new collaboration of countries and partners worldwide, driving innovations to increase availability of key data; develop state of the art analytic tools and predictive models for risk analysis; and link communities of practice around the world.
MHRA updates registers of licensed manufacturing sites for human and veterinary medicines
On 1st September 2021, the MHRA updated the registers of licensed manufacturing sites for human and veterinary medicines.
MHRA updates registers of licensed wholesale distribution sites for human and veterinary medicines
On 1st September 2021, the MHRA updated the registers of licensed wholesale distribution sites for human and veterinary medicines.
Issue Number: WN00026