How Medicines Are Approved Around the World: SAHPRA, FDA, EMA and WHO

Before any medicine reaches a pharmacy shelf, it passes through a regulatory approval process designed to establish three things: that it is safe for its intended use, that it actually works, and that it is manufactured to a consistent quality. Every country runs some version of this process, but the systems differ in scale, speed and approach.

This article gives a plain-language overview of how the major regulators evaluate medicines, and how South Africa’s SAHPRA fits into the global picture.

The big three: FDA, EMA and MHRA

The United States Food and Drug Administration (FDA) is the world’s most influential medicines regulator. Manufacturers submit a New Drug Application (NDA) or, for biologics, a Biologics License Application (BLA), containing the full clinical trial record. FDA review typically takes 10 to 12 months under standard review, or around 6 months under priority review.

The European Medicines Agency (EMA) coordinates a centralised procedure for the European Union: a single scientific assessment by its Committee for Medicinal Products for Human Use (CHMP) leads to a marketing authorisation valid across all EU member states.

The United Kingdom’s MHRA became a fully independent regulator again after Brexit and now runs its own national approvals, alongside international reliance routes that let it fast-track products already approved by trusted peer agencies.

How SAHPRA registers medicines in South Africa

The South African Health Products Regulatory Authority (SAHPRA) is responsible for registering every medicine sold in South Africa under the Medicines and Related Substances Act. A product registered by SAHPRA receives a registration number and appears in the public registration database.

Like many mid-sized regulators, SAHPRA makes extensive use of regulatory reliance: where a product has already been approved by a stringent regulatory authority such as the FDA or EMA, SAHPRA can lean on that assessment rather than repeating the entire review from scratch. This shortens timelines without lowering the evidence bar.

SAHPRA also schedules medicines (Schedule 0 through Schedule 8), which determines whether a product is available off the shelf, from a pharmacist, or on prescription only.

The WHO prequalification programme

For many low- and middle-income countries, the World Health Organization’s prequalification (PQ) programme acts as a trusted quality benchmark. WHO-prequalified medicines, vaccines and diagnostics have been assessed for quality, safety and efficacy, and international procurement agencies such as the Global Fund and UNICEF generally require prequalification before purchasing.

Prequalification matters enormously for products like antiretrovirals, TB treatments and antimalarials — categories that dominate the public-health burden in Southern Africa.

Why the same medicine can have different approval status by country

Approval is national (or regional). A medicine approved by the FDA is not automatically legal to sell in South Africa, and vice versa. Differences in approved indications, dosage forms and even brand names between countries are common and normal.

That is why checking a local register matters: in South Africa, SAHPRA’s database is the authoritative record of what is actually registered, and the Medicine Price Registry records the regulated Single Exit Price for each registered product. You can search both from the HealthSA search page.