The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has announced "the imminent publication of a ‘Good Pharmacovigilance Practice Guide’ which is intended to complement currently available legislation and guidance, and to provide practical advice about achieving an appropriate system of pharmacovigilance.
Over recent years there has been an increasing public awareness for safety issues relating to medical products. The recognition of the importance of pharmacovigilance has also grown, and both regulatory agencies and pharmaceutical companies seek to ensure that emerging safety information is reported and appropriate action is taken to safeguard public health.
It is intended that the guide will complement currently available legislation and guidance, and will provide practical advice about achieving an appropriate system of pharmacovigilance.
It has primarily been developed for UK Marketing Authorisation Holders (MAHs) but will also be of interest to pharmacovigilance consultants, contractors and service providers. The guide makes reference to European legislation and guidance and should be applicable across Europe.
Pharmacovigilance is not confined to one department within an organisation, and so the guide aims at taking a holistic approach, considering the specific requirements defined in legislation and also other activities that impact on pharmacovigilance in a more subtle way."
The ‘Good Pharmacovigilance Practice Guide’ is published by and available from Pharmaceutical Press.
Source: MHRA Medicines Regulatory News
On behalf of the European Compliance Academy (ECA)