Switzerland first to pass EU’s ‘equivalence’ test for APIs

pharmafile | December 12, 2012 | News story | Manufacturing and Production API, China, EU, FMD, MHRA 

Switzerland has become the first country to be classed as having equivalent standards for the manufacture of active pharmaceutical ingredients (APIs) under new EU rules.

The white listing of Switzerland among countries with equivalent API standards allows it to sidestep the new and controversial requirement – introduced via last year’s falsified medicines directive (FMD) – of written confirmation that APIs imported into the EU meet appropriate standards.

The FMD introduced a need for API shipments to be accompanied by written confirmation from the competent authority of the exporting third country that they comply with “standards of good manufacturing practice and control of the plant are equivalent” to those in the EU.

The changes are due to come into effect next July but have been opposed by some major API exporting countries – including India and China – with suggestions that some APIs may become scarce once the regulations are in place.

According to the minutes of a stakeholder meeting convened by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last month, only Canada and Taiwan have so far agreed to issue the declarations.

Meanwhile, apart from Switzerland, Australia, Brazil, Israel and Singapore have also applied for white listing, according to the meeting. Switzerland was included after the European Commission carried out an assessment of its regulatory system for GMP control and supervision of APIs.

The MHRA has reservations about the requirements, recommending that the Commission consult with third-country authorities to gauge the level of regulatory burden and assess whether they are able to comply with them.

There is also concern that some marketing authorisation holders (MAHs) may also decide to shift medicine production outside the EU, with the British Generic Manufacturers Association (BGMA) suggesting at the MHRA meeting that some of its members have already done so.

Phil Taylor

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