New Best Practice Guides for the Submission and Processing of Variations published
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has published the latest version of its Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Read more.
English Supervisory Authority MHRA Publishes Answers to FAQs on Risk Management
On its homepage, the English supervisory authority, MHRA, has published answers to frequently asked questions regarding the topic of quality risk management. Here you can read the answers.
New Best Practice Guides for the Submission and Processing of Variations published
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human has updated the Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Find further information here.
A concrete instruction for the implementation of the CAPA requirements cannot be found in the hitherto existing guidelines. Here, a newly proposed guidance by the GHTF can help. Read more here.