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Post Marketing Surveillance Methods – South Africa
Post marketing surveillance (PMS) is the practice of monitoring a pharmaceutical drug or device after it has been released on the market. PMS is a function of the Medicines Control Council (MCC), the regulatory authority in South Africa. The MCC’s PV Committee was comprised of a pharmacist and six external experts from various. Types – Active safety surveillance, Passive safety surveillance, stimulated reporting, Comparative Observational Studies.
PROCEDURES FOR REPORTING
- Who to Report To – National Adverse Drug Event Monitoring Centre, Registrar of Medicines
- Route of Notification –. It should be sent by post, or by facsimile
- Report Format – Adverse reaction report form available from the NADEMC or holders of a certificate of registration may use their in-house report forms.
- Follow-Up Reports Any follow-up information must be cross-referenced to the unique number assigned by the holder of a certificate of registration. A CIOMS format “initial” report which follows a previous (first) communication from the holder of a certificate of registration must be clearly marked that it is a follow up and linked through the applicant-assigned reference number. The only reliable way to minimize the duplication of reports, submitted by holders of a certificate of registration, in the NADEMC’s ADRI database.
Type of ADR report
Time frame for reporting
|South African Reports (spontaneous/published/study):
• Serious (expected and unexpected)
• Non-serious (expected and unexpected)
|15 days Annually||ADR form, Summary report|
|Foreign Reports (spontaneous/published/study):
|On request or relating to specific safety issue||As appropriate|
|Notification of Change in Nature, Severity or Frequency or Risk factors||15 days||Detailed report (including publications)|
|New information impacting on benefit-risk profile of product including international regulatory decisions||3 days||Detailed report (including publications)|
South Africa is having a legal framework in place requiring that adverse events be monitored both actively and passively.