MHRA says 1,200 API plants may need inspecting under new import laws

By Gareth Macdonald

- Last updated on GMT

Related tags European union

MHRA says 1,200 API plants may need inspecting under new import laws
The MHRA says as many as 1,200 active pharmaceutical ingredient (API) manufacturing plants may need to be inspected to secure UK supply chains when new EU import laws come into effect next year.

The Agency made the prediction​ when it met to discuss the potential impact the requirement that actives made outside the EU are accompanied by written confirmation of quality​ will have on the availability of drugs in the UK.

It said that it has "identified a potential of 1200 sites named across 8000 Marketing Authorisations. Ten other Member States have identified similar patterns​.”

MHRA spokesman Matthew Niizeki told that: “The MHRA has written to all heads of Medicines Agencies requesting information on the number of third country API manufacturing sites and the number of licensed medicinal products that name those sites on the marketing authorisation of products that are used in their country.

This is in order to help with the overall scoping planning for the measures provided in the Falsified Medicines Directive in respect of the active substances​,” he continued, adding that the 1,2000 figure is an estimate based on data received so far.


The MHRA also raised concerns that while regulators in Canada and Taiwan have agreed to issue API manufacturers with written confirmation of quality, the European Commission has still not received assurances from authorities in other key countries.

The position with China, India, Japan and Mexico remains unclear. The Commission discussions are ongoing with each,”​ it said, adding that: “The UK may have to reserve its position in respect of active substances imported from third countries in order to ensure availability of medicinal products.”

When we asked the MHRA to clarify what it meant by ‘reserve its position’ the organisation said that the “UK will have to take a view of the position following full transposition of matters in respect active substances come July 2013​.”

Inspection capacity

The MHRA meeting – which involved representatives from the ABPI, PAGB, BIA and the PQG – took place just a week or so before the European Commission (EC) granted Switzerland exemption​ from the ‘written confirmation’ requirement.

Switzerland is one of five countries to seek such exemption – the others being Australia, Brazil, Israel, Singapore – on the grounds that national GMP provisions for active substance manufacture is equivalent to EU-GMP.

The idea is that granting such waivers to countries in which APIs are produced to appropriate quality standards will allow regulators in EU member states to focus inspection efforts elsewhere. However, comments by the MHRA during the meeting suggest that even this may not be enough.

The organisation was asked whether it had the resource to inspect third country active substance manufacturers and responded it has allowed 30 to 40 man days a year for "triggered inspections of active substance sites which worked out to about ten a year​."

A second attendee asked if the MHRA has enough resources to inspect API plants in third countries that have not applied for exemptions to to ensure the security of supply of active substances for pharmaceuticals.

The regulator responded that: “Currently the MHRA does not have sufficient resource to inspect active substance producers in third countries that have applied to be considered for acceptable GMP standards.”

Note for acronym fans: Association of the British Pharmaceutical Industry (ABPI); the Proprietary Association of Great Britain (PAGB); the BioIndustry Association (BIA); and the Pharmaceutical Quality Group (PQG).

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