South African Health Products Regulatory Authority updated its guidance on Pharmacovigilance Inspections for Human Medicinal Products.
This guideline pertains to the planning, conducting, reporting and following-up of Pharmacovigilance inspections in South Africa. This guideline is designed to facilitate compliance by the applicants/HCRs and to enhance consistency in the application of the regulatory requirements regarding good pharmacovigilance practices.
South African Health Products Regulatory Authority (SAHPRA) shall conduct pharmacovigilance inspections of applicants/HCRs or any licence holder employed to fulfil the applicant/HCR’s pharmacovigilance requirements to ensure compliance with regulatory pharmacovigilance obligations.
The purpose of this guideline is to provide guidance on areas of inspection for applicants/HCRs and their contractors, to ensure that they:
have an adequate and effective quality system for monitoring the medicines in order to protect public health;
maintain a pharmacovigilance system master file;
have adequate, competent, appropriately qualified, and trained staff to work on the pharmacovigilance system;
comply with the pharmacovigilance obligations as per the Medicines and Related Substance Act (Act 101 of 1965) as amended.
The objectives of pharmacovigilance inspections are:
to ensure that applicants/HCRs have personnel, systems and facilities in place to meet their pharmacovigilance obligations;
to improve the pharmacovigilance system established by applicants/HCRs;
to identify, record and address non-compliance which may pose a risk to public health;
to use the inspection results as a basis for enforcement action, where considered necessary.
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