WHO Draft Guidance: Selecting the Right Analytical Screening Technologies for Substandard and Falsified Medicines

The World Health Organization (WHO) has published a new draft working document (QAS/26.1004, June 2026) titled "WHO Guidance on the Selection and Use of Technologies to Screen and Detect Substandard/Falsified (SF) Medicines".

Background

In the document introduction section, it is stated that "substandard and falsified (SF) medicines pose a serious but often underestimated threat to public health". A 2017 WHO report estimated that around 10% of medicines in low- and middle-income countries (LMICs) are substandard or falsified, depriving patients of safe and effective treatment.

Regulatory authorities are primarily responsible for detecting and responding to SF medicines. "Ideally, detection is carried out using compendial methods, which rely on validated analytical procedures and often use high-performance liquid chromatography (HPLC) for qualitative and quantitative analysis. These methods provide accurate results but are expensive, time-consuming, and require sophisticated equipment and highly trained staff, which means they must be performed in a laboratory."

In many settings, testing capacity is insufficient to meet demand. Screening technologies can help address this gap by enabling rapid assessment of large numbers of samples at lower cost and with less infrastructure.

Against this background, "the purpose of this guidance is to improve Member States' understanding and uptake of technologies to screen and detect substandard and falsified medicines." The document provides structured guidance on the selection and implementation of rapid analytical screening technologies for medicine quality control. It is aimed at national regulatory authorities, quality control laboratories, and other supply chain stakeholders.

Content

The guidance covers the following established screening technologies:

• Raman spectroscopy (including SORS and SERDS variants)
• Near-infrared (NIR) spectroscopy
• Mid-infrared (MIR) spectroscopy
• Thin-layer chromatography (TLC/HPTLC)
• Colorimetric paper analytical devices (PADs)

Each technology is assessed against defined analytical performance criteria, including:

• API identity confirmation
• API quantitation
• Impurity profiling
• Detection of incorrect enantiomers and unknown APIs
• Brand differentiation
• Detection of DEG/EG contamination

Technologies are further compared on operational parameters such as analysis time, cost, portability, sample destruction, calibration requirements, and need for reference standards.

The document also briefly addresses emerging technologies not yet in widespread use (e.g. XRF, lateral flow immunoassays, nanosensors) and advanced laboratory methods (HPLC, mass spectrometry, XRPD) for confirmatory testing. A section on procurement of field-portable devices covers supplier qualification and technology-specific considerations.

Download and Comments

The document is currently open for public consultation and can be downloaded from the WHO website under "Working documents in public consultation".

Comments can be submitted via the WHO PleaseReview™ platform until 31 August 2026.