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The GLP News pages on the website have been updated today.
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.
Starting in September, MHRA is making careful preparations for a safe return to normal UK on-site inspection scheduling.
China - Circular of the State Food and Drug Administration on Issuing the Guidelines for the Preservation of Essential Documents for Drug Clinical Trials
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 firstname.lastname@example.org by 18 September 2020.
First edition of the Veterinary Medicines Regulation Highlight - 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.
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....
List of manufacturers and their medical devices which have been granted an exemption by the MHRA
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.