Primary source: Cancellation of Notified Cosmetic Products
New reporting requirements have been established for consumers to report suspected side effects of medicines and vaccines through the ConSERF form.
This initiative enhances drug safety monitoring by increasing consumer engagement and compliance with safety reporting protocols.
Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.
This may necessitate additional resources for evaluating and processing consumer reports.
Increased consumer engagement in reporting side effects.
Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has introduced a consumer side effect reporting mechanism called ConSERF. This allows consumers to report suspected adverse drug reactions (ADRs) or adverse events following immunization (AEFI) either online or via a printed form. Detailed instructions and a dedicated reporting form are available on their website.
What changed: New reporting requirements have been established for consumers to report suspected side effects of medicines and vaccines through the ConSERF form.
Why it matters: This initiative enhances drug safety monitoring by increasing consumer engagement and compliance with safety reporting protocols.
Practical implication: Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.
Published from the regulator source ingestion pipeline after PV impact triage.
Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.
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Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.
