A principle objective of both the MHRA and of pharmaceutical companies is to protect and improve the health of patients. When new information about the benefits and risks of a medicine become available it is often appropriate to make changes to the safety information for the product.
Good pharmacovigilance practice
The GXP environment is evolving as digital technologies are increasingly being applied to the development and manufacture of medicines.
From 8 to 10 April 2019, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
In a bid to drive improved compliance and to cover the cost of managing more resource-intensive cases, the Inspectorate intends to apply the existing office-based assessment fee more broadly.
The MHRA pharmacovigilance inspection metrics for the period from April 2017 to March 2018 are now available on GOV.UK
The GPvP webpage has recently been updated to provide additional information about the current inspection process. This post provides some further information about GPvP inspectors and inspections.
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
In may, the GPvP Inspectorate held their symposium, which provided a platform for information sharing and discussion between inspectors and assessors from the MHRA and industry colleagues working within pharmacovigilance and associated departments.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
The MHRA’s GXP data integrity guide has been published today.