Communication to industry on Post Marketing Reporting of ADRs guideline

Communication to industry on Post Marketing Reporting of ADRs guideline

The South African Health Products Regulatory Authority (SAHPRA), have reviewed the Post Marketing Reporting of ADR guideline following concerns raised by the industry on version 7 of the guideline published September 2020. In addition to the review, SAHPRA conducted a webinar with holders of certificate of registration to further discuss the concerns and proposed responses to the queries.

2021 May

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File Type: pdf
Category: Communication to industry
Unit: pharmacovigilance