EMA consultation: Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6

23rd July 2020

The European Medicines Agency has published for public consultation for a concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6.

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MHRA planning for return to on-site Good Practice (GxP) inspections

23rd July 2020

Starting in September, MHRA is making careful preparations for a safe return to normal UK on-site inspection scheduling.

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China - Guiding Principles for the Preservation of Prepared Documents

22nd July 2020

China - Circular of the State Food and Drug Administration on Issuing the Guidelines for the Preservation of Essential Documents for Drug Clinical Trials

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EMA published for public consultation on a draft access policy: Union Product Database Access Policy (UPD) - Veterinary Medicinal Products.

22nd July 2020

Veterinary stakeholders are invited to comment on a draft access policy for the Union Product Database, which will provide information on all authorised veterinary medicines and their availability in EU Member States. The access policy sets out the types of information different user groups should be allowed to access once the database becomes operational in January 2022. Implementation of the Union Product Database is required by the new Veterinary Medicines Regulation. For more information, see Implementation of the new Veterinary Medicines Regulation. Stakeholders should submit comments on the access policy to vetchange.programme@ema.europa.eu by 18 September 2020.

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First edition of the Veterinary Medicines Regulation Highlight

22nd July 2020

First edition of the Veterinary Medicines Regulation Highlight - July 2020

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Pharmacovigilance Audits and Inspections during COVID-19

22nd July 2020

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes Q&As relating to pharmacovigilance.

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MHRA - A Practical example of applying Quality Risk Management in GDP – Transportation Risks

15th July 2020

What is your biggest GDP risk? If you had to think about the answer, then it is likely that you haven’t given it much thought. Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation....

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Medical devices given exceptional use authorisations during the COVID-19 pandemic

14th July 2020

List of manufacturers and their medical devices which have been granted an exemption by the MHRA

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020

14th July 2020

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.

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International regulators provide guiding principles for COVID-19 clinical trials

6th July 2020

EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA).

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