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News Archive
International regulators and WHO call for wider public access to clinical data
12th May 2021The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity and can stimulate research and development, which could have a positive impact on vaccine confidence.
MHRA - Guidance on the licensing of biosimilar products
12th May 2021MHRA have produced a new 'Guidance on the licensing of biosimilar products'.
MHRA - Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision
12th May 2021The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) is currently undergoing a major revision.
MHRA - With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind.
12th May 2021With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021
12th May 2021This month EMA’s safety committee (PRAC) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.
EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
20th April 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
20th April 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
FDA - First Device that Uses Artificial Intelligence
20th April 2021FDA Authorises Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer. Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance
MHRA - Transparent Facemasks
20th April 2021Regulatory status of equipment being used to help prevent coronavirus (COVID-19) - addition of section about transparent facemasks
EMA - third public meeting on COVID-19 vaccines
7th April 2021Available to view now on YouTube.
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