The South African Health Products Regulatory Authority (SAHPRA) has issued a final call to pharmaceutical companies marketing orally administered phenylephrine-containing medicines, demanding robust scientific evidence to justify their continued registration. This follows mounting concerns over the drug’s effectiveness as a nasal decongestant.
In a formal communication to Holders of Certificates of Registration (HCRs), SAHPRA reiterated its stance that existing data do not support the efficacy of phenylephrine in its oral form. The announcement comes after a series of engagements with stakeholders and a review of submissions received in response to the Authority’s initial request in July 2024.
According to SAHPRA, the majority of HCRs failed to respond within the original 90-day deadline, and the few submissions received were deemed inadequate. The Advisory Clinical Committee concluded that the available scientific evidence does not substantiate the claimed benefits of orally administered phenylephrine at recommended dosages.
In January 2025, SAHPRA issued a second notice, signalling its intention to classify these medicines as “undesirable” unless compelling efficacy data were provided. This prompted a series of meetings with industry stakeholders, many of whom requested additional time to compile the necessary evidence.
In response, SAHPRA has now granted a six-month extension, setting a new deadline of 15 November 2025. By this date, HCRs must submit either:
Clinical efficacy data specific to single-agent phenylephrine formulations; or
A high-quality meta-analysis or systematic review compliant with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.
The Authority emphasised that all submissions must be scientifically robust and directly relevant to the claimed indications. Failure to comply will result in regulatory action, potentially including the withdrawal of market authorisation.
Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, reaffirmed the Authority’s commitment to evidence-based regulation, stating:
“Our priority is to ensure that all health products available in South Africa meet the highest standards of safety, efficacy, and quality.”
This development places the onus squarely on pharmaceutical companies to substantiate the therapeutic value of their phenylephrine products or risk losing their registration status.
