Amid growing interest in Section 21 applications, South Africa’s national regulator launches enhanced online submission portal.
The South African Health Products Authority (SAHPRA) has introduced a new and improved online submission portal for Section 21 applications (Category A Medicines). The outcome of extensive work behind the scenes over the past few months, the refurbished portal is expected to enhance communication between the regulator and applicants amid growing interest in Section 21 applications. A Section 21 authorization is granted to allow for access to medicines on an exceptional basis, in instances whereby conventional therapies have either been ruled out, have failed or are not available as marketed products. The regulator recently granted such authorization to the Covid-19 vaccine manufactured by Pfizer and BioNTech, of which South Africa has ordered 20 million doses.