How Blood Products and Plasma-Derived Medicines Are Regulated

Blood products and plasma-derived medicines form a unique category of therapeutics. They are so fundamental to healthcare that whole blood and specific plasma fractions are listed on the World Health Organization (WHO) Essential Medicines List (EML). Unlike conventional pharmaceuticals synthesised chemically in a laboratory, these treatments originate from human donations. They include whole blood, red blood cells, and platelets used for transfusions, as well as plasma-derived medicinal products (PDMPs) such as albumin, immunoglobulins, and clotting factors. Because they are extracted from human biological material, they carry inherent risks of transmitting infections and causing immune reactions. Consequently, regulators worldwide apply a specialised, highly stringent framework to govern their collection, testing, manufacturing, and distribution.

Why blood products are treated specially

The primary reason blood products receive special regulatory attention is their biological origin. When a conventional medicine is synthesised, its molecular structure is entirely known and reproducible. In contrast, human blood is inherently variable, and its components carry potential pathogens. Donor blood can harbour viruses such as HIV, hepatitis B, and hepatitis C, as well as parasites like malaria or emerging infectious agents.

Furthermore, receiving blood from another person introduces foreign cells and proteins, which can trigger severe immune reactions. These include transfusion-associated graft-versus-host disease or haemolytic reactions if blood types are mismatched. To manage these unique risks, blood products are regulated not just as standard manufactured goods but as biological therapies requiring 'vein-to-vein' oversight. This means regulators track the product from the moment it leaves the donor's vein to the moment it is administered to the patient.

Donation screening and safety testing

Ensuring the safety of blood products begins long before manufacturing. Regulatory guidelines require rigorous donor selection processes to identify and defer individuals at higher risk of carrying blood-borne infections. This typically involves detailed health questionnaires and interviews, alongside the temporary or permanent deferral of donors who have recently travelled to endemic regions, undergone certain medical procedures, or engaged in high-risk behaviours.

Once donated, every unit of blood undergoes mandatory laboratory testing. Modern testing utilises serological assays to detect antibodies and antigens, alongside nucleic acid testing (NAT). NAT is highly sensitive and detects the genetic material of viruses, significantly reducing the 'window period'—the brief time between initial infection and when a test can reliably detect it. Only after passing these comprehensive screens is the blood separated into its components or pooled for further processing.

Manufacturing and viral inactivation

Plasma-derived medicines are manufactured through a complex process called fractionation, where plasma is separated into its constituent proteins. Because PDMPs often require pooling plasma from thousands of individual donors, a single contaminated unit could theoretically compromise an entire batch. Therefore, manufacturing must adhere to strict Good Manufacturing Practice (GMP).

Beyond testing individual donations, manufacturers employ dedicated viral inactivation and removal steps. Common techniques include solvent-detergent treatment, which dissolves the lipid envelopes of viruses like HIV and hepatitis C, pasteurisation, and nanofiltration, which physically traps viruses based on size. Regulatory authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) inspect these facilities extensively to ensure that the purification and viral reduction processes yield safe, consistent products. Strict traceability requirements ensure that every batch can be traced forward to the recipient and backward to the donors.

The South African context and SANBS

In South Africa, the South African National Blood Service (SANBS) is responsible for collecting, testing, and distributing the vast majority of the country's blood supply. South Africa relies on a model of voluntary non-remunerated blood donation, which the WHO considers the safest foundation for a national blood supply, as unpaid donors generally have lower rates of transfusion-transmissible infections.

The SANBS operates under the regulatory oversight of the South African Health Products Regulatory Authority (SAHPRA). Under the Medicines and Related Substances Act, SAHPRA classifies blood and blood products as medicines, meaning collection protocols, testing algorithms, and the final distribution of plasma-derived therapies must all meet stringent national standards. While blood for direct transfusion is supplied as a clinical service, manufactured plasma-derived medicines distributed commercially in South Africa are subject to pharmaceutical pricing frameworks like the Single Exit Price (SEP). Patients and healthcare providers can use the HealthSA search tool to verify the SAHPRA registration status of specific commercial plasma-derived medicines.