Delivering High Standards in Medicines Advertising Regulation report 2020

26th May 2021

Annual report from the MHRA on the regulation of medicines advertising to promote transparency.

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EMA - Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021

26th May 2021

Highlights of the committee meeting.

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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 2021

26th May 2021

CVMP opinions on veterinary medicinal products

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FDA - Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry

26th May 2021

This guidance provides a framework to facilitate the management of post approval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. The guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and is composed of a Core Guideline and two Annexes.

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MHRA - Notify the MHRA about a clinical investigation for a medical device

26th May 2021

Notify the MHRA about a clinical investigation for a medical device - update to guidance concerning Northern Ireland.

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Red4Research

26th May 2021

#Red4Research Day on Friday 18th June 2021

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EMA - public consultation on European Health Data Space (EHDS)

12th May 2021

We would like to inform you that the European Commission has launched a public consultation on European Health Data Space (EHDS), which aims to make full use of digital health to provide high-quality healthcare and reduce inequalities. It will promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policy-making and legislation.

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International regulators and WHO call for wider public access to clinical data

12th May 2021

The 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.

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MHRA - Guidance on the licensing of biosimilar products

12th May 2021

MHRA have produced a new 'Guidance on the licensing of biosimilar products'.

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MHRA - Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision

12th May 2021

The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) is currently undergoing a major revision.

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