Medicines testing

The MHRA has a continuous programme of sampling and analysis of medicinal products marketed in the UK that aims to confirm the quality of these products.  Each year 2,000-2,500 samples are analysed.  These may be provided by other groups in the Agency for specific regulatory purposes or may have been commissioned by Agency staff as part of a national surveillance project.

Various types of products are tested within the programme including:

• licensed medicines;  
• unlicensed medicines;
• herbal products; and
• active pharmaceutical ingredients (APIs).

Surveys of medicines on the UK market are selected by staff within the Medicines Testing Unit on the basis of a risk assessment. Samples are randomly procured directly from manufacturers, wholesalers or from community pharmacists with the aim of sampling from the whole of the supply chain. The objectives of the market surveillance program are met through the design and implementation of the market surveys, and the design and control of analytical protocols to ensure data are valid and accurate. 

The Medicines Testing Unit will analyse samples 'on-demand' for other Agency staff in support of the enforcement, regulatory or inspection process. Samples are obtained principally from the MHRA’s enforcement officers during investigations and by MHRA inspectors during inspections of both manufacturers and distributors of medicinal products.  The MHRA Licensing and Post Licensing assessors may request analytical data; the results of their analyses are used to provide further evidence regarding decisions by the assessors for the granting of marketing authorisations (MAs) and variations to current MAs. Analytical investigations are also carried out for the Defective Medicines Reporting Centre to support its defect assessments and confirm reported defects

In addition to testing products licensed in the UK, the MHRA participates in the analytical surveillance programme for products authorised under the European Centralised Licensing procedure (CAP). The European Directorate for the Quality of Medicines (EDQM) co-ordinates a sampling and testing programme for CAP on behalf of European Medicines  Agency (EMEA).  Samples are taken in three different member states and analysis is undertaken in the Official Medicines Control Laboratories (OMCL) of two Member States.  The MHRA also takes part in a collaborative programme of sampling and analysis of products authorised under the Mutual Recognition procedure (MRP). Sampling programmes and results of analysis for MRP are circulated in a database to all countries participating in the programme.

The Medicines Testing Unit supports the work of the Enforcement and Borderline Sections of the Agency by providing scientific and technical support where required. It provides forensic analysis reports to support enforcement prosecutions and has developed expertise in the analysis of illegal medicines including:

• the identification and analysis of counterfeit medicines;
• the identification of illegal medicinal substances in herbal and natural remedies; and
• the identification of banned herbal medicines.

Table 1 summarises the types of samples analysed in the years 2000-2004. Table 2 gives a further summary of the market surveillance studies undertaken up to 2004.