News Archive

EMA - SME Office Newsletter 58

10th May 2023

The newsletter for micro-, small- and medium-sized enterprises (SMEs),

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EMA - Statement from Emer Cooke on the end of the COVID-19 public health emergency

10th May 2023

On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the coronavirus SARS-CoV-2. I welcome this important milestone and would like to share some thoughts about what this means for EMA.

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FDA - Additional Steps to Advance Decentralised Clinical Trials

10th May 2023

The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.

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FDA - Q9(R1) Quality Risk Management

10th May 2023

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.”

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MHRA - Good Manufacturing Practice Symposium 2023

10th May 2023

A write up of the event by Graham Carroll

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MHRA - ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

10th May 2023

The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These are anticipated to reach Step 2 soon and will be available for public consultation.

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MHRA - Implementation of the Future Regulations

10th May 2023

The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.

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MHRA - Publication Scheme

10th May 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to making transparency and accountability to the public a fundamental principle of how we do business.

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MHRA Blog - Ensuring Child Vaccine Safety at Every Step

10th May 2023

Shiva Ramroop, discusses how we ensure the safety of vaccines for children in the UK.

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Swissmedic - Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers

10th May 2023

Clarification of the requirements for the submission of audit reports

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