WHO now issues draft guidance to test suspected spurious, falsely-labelled, falsified and counterfeit medicines

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The World Health Organisation (WHO) has now issued draft guidance to test suspected spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines. It expects the industry to comment before January 10, 2017.

The regulator has stated that the national and regional regulatory authorities (NRAs) are responsible to put in norms to control production, distribution and commercialization of medical products in order to ensure their quality through rigorous regulatory oversight, including post-marketing surveillance.
 
Rigorous regulatory oversight of medical products throughout their life cycle is necessary to recognize and remove SFFC products and to protect the supply chain against infiltration of such products. SFFC products originate from outside the legal supply chain. It is important that NRAs control the supply chain and raise awareness of health workers and patients of risks associated with medicines from illegal sources, said WHO.

The role of WHO, through its Expert Committee on Specifications for Pharmaceutical Preparations, sets technical standards on quality assurance of pharmaceutical products, including guidance on registration, good manufacturing practices (GMP), good distribution practices (GDP) and quality control (QC) testing of medicines and other topics that are relevant to the regulatory oversight of medicines.
 
This document provides technical guidance on laboratory testing of samples of suspected SFFC products detected on the market of WHO Member States and related aspects of sampling and reporting.

Regulatory authorities are responsible for establishing mechanisms to detect SFFC products circulating in their territories and to remove them from the market. Suspected SFFC products can be detected using a range of approaches, including routine inspections performed by national or regional authorities and enforcement agencies, targeted risk-based surveys.
 
SFFC products may be identified by their fake packaging and/or by physical and chemical testing. The packaging and patient information leaflets of suspect SFFC medicines should always be examined visually and compared with samples or images of genuine products if available. Attention should be paid to any irregularities or inconsistencies, such as spelling mistakes, unusual batch numbers, unexpected or modified manufacturing or expiry dates, signs of  repacking, for example, to circumvent inspection activities, or instructions in a language that does not match the area of their distribution. Microscopy and other analytical techniques need to  be utilized for the package examination, said the regulatory authority.
 
In the context of law enforcement, the result of a screening test is only indicative and other analytical techniques must be applied to unequivocally confirm that an SFFC product has been detected. Documentation should be prepared with information on everything that is known about the sample, including the point of detection, the volume of suspect product found, a visual description of its packaging and the dosage units including any signs of irregularities. Further, the supply history of the product and what led to its detection including adverse effects and any other relevant information needed to be provided.

Source: 1, 2

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