EFPIA Backs MHRA Plan to Inspect APIs at Plants Not Ports
Last week the Medicines and Healthcare Products Regulatory (MHRA) reiterated its intention to check active pharmaceutical ingredients (API) shipped to the UK from outside the European Union have the correct documentation at drug production sites and distribution centres.
It explained that: “The UK will not control AS [Active substances or APIs] import at the border and will instead control at inspection of manufacturers and, where there is a risk trigger, at inspection of AS importers and distributors.”
The decision, which coincided with the introduction of the Falsified Medicines Directive (FMD) into UK law, was welcomed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which told in-Pharmatechnologist.com that: “The MHRA approach will not trigger additional inspections at the time of import.”
The organisation went on to say that: “This will be part of the already existing inspections programme at the Product Manufacturing sites, and EFPIA supports such approach,” and added that impact on resources for both manufacturers and the UK agency will be limited.
EFPIA on FMD
The comments are in keeping with others EFPIA has made about the FMD and the introduction of new import rules that require that APIs shipped to the European Union (EU) are accompanied by written confirmations of manufacturing quality from regulators in the country of origin.
For example in July, amid drugmaker and regulator concerns the rules would prevent vital APIs from reaching Europe, EFPIA told this publication that: “In the immediate future, no drug shortage is foreseen” although it said that the next six months while the system matures “would be critical.”
EFPIA’s backing for the MHRA’s inspection plan suggests that the industry group has not changed its view in the two months since the FMD was introduced.
