Why Medicine Registration Takes Years

When a new medicine reaches a pharmacy shelf, it often arrives years after the manufacturer first filed paperwork with a medicines regulator. Patients and prescribers sometimes wonder why the gap is so long, particularly when the product is already sold in another country. The delay is not simply bureaucratic inertia. Medicines registration is a structured, evidence-based assessment process, and it involves queues, review cycles, and sometimes repeat submissions before a product is approved.

The dossier: what a registration application contains

A registration application is built around a document called a dossier. The internationally standardised format is the Common Technical Document (CTD), developed through the International Council for Harmonisation (ICH), which organises the application into five modules. Module 1 contains administrative information specific to the country of application — forms, labelling, and local certificates. Modules 2 through 5 cover the quality, non-clinical, and clinical data in a structured way that allows different regulators to navigate the same set of information.

For a new active substance, the clinical module alone can run to thousands of pages, summarising trial data across all phases of development. Regulators must assess whether the medicine is of acceptable quality, whether it is safe enough for its intended use, and whether it works for the condition claimed. Generic applications are generally shorter but still require evidence that the product is bioequivalent to a reference product and manufactured to acceptable standards. The volume and complexity of the dossier is the first reason review takes time — a thorough assessment cannot be completed in weeks.

Queues, backlogs, and priority pathways

Even a well-prepared dossier enters a queue. Regulatory authorities receive many applications and typically have a limited number of reviewers with the necessary scientific expertise. When applications arrive faster than reviewers can complete assessments, a backlog accumulates. Backlogs have been documented at regulators across both high- and middle-income settings, and clearing them can take years.

To manage queues, many regulators operate tiered or priority systems. Applications for medicines addressing unmet medical needs, or for products relevant to public health emergencies, may be fast-tracked. Standard applications sit in a different queue, and some regulators also maintain a separate queue for generic applications. These tiers help direct limited resources, but they also mean that a routine application can wait longer than one might expect based on review time alone.

The review itself is often iterative. Regulators issue questions or requests for additional data, the applicant responds, and the cycle may repeat. Each round adds months. If a manufacturing site inspection is needed, that too is scheduled into the timeline, and inspection capacity is itself often constrained.

Reliance and work-sharing between regulators

Because building dossier assessment capacity is expensive and slow, regulators increasingly use mechanisms that let them rely on the work of trusted counterparts. The World Health Organization evaluates and classifies national regulatory authorities according to their maturity and capability, providing a basis for recognising which authorities produce assessments that others can trust. When a product has already been assessed by a mature or recognised regulator, another regulator may accept that assessment as the basis for its own registration decision rather than repeating the full review independently.

Work-sharing arrangements take this further. Groups of regulators may divide a dossier so that each reviews specific sections and then shares findings with the others. Examples include regional harmonisation initiatives and multilateral cooperation frameworks, several of which have emerged in recent years. These approaches are intended to reduce duplicated effort and shorten timelines without lowering the standards each regulator applies.

SAHPRA reliance pathways in South Africa

In South Africa, the South African Health Products Regulatory Authority (SAHPRA) is responsible for medicine registration. SAHPRA has historically faced significant application backlogs, a challenge widely acknowledged within the sector. To address this, SAHPRA has introduced reliance-based pathways that allow it to register medicines more efficiently when they have already been approved by recognised reference regulators.

Under these pathways, SAHPRA can rely on assessments from specified established regulators — such as the US Food and Drug Administration, the European Medicines Agency, or other regulators recognised by the WHO — rather than conducting a full independent review from scratch. This can shorten the timeline substantially for products that are already approved elsewhere. It also allows SAHPRA to focus its independent review capacity on products that have not been assessed by a recognised regulator or that raise specific local considerations.

For users of HealthSA, this means that a medicine approved in Europe or the United States may appear on the SAHPRA register sooner than one might expect if every product had to go through a full independent review. Searching HealthSA can help confirm whether a particular product has been registered in South Africa and provide context for its local availability.