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SFDA may forge closer ties with Swissmedic

By Gareth Macdonald , 06-Feb-2013

The SFDA wants to forge closer ties with regulators in Switzerland, to date the only country granted exemption from new EU API import laws.

Earlier this week the Chinese State Food and Drug Administration (SFDA) website announced that commissioner Yin Li had met Swiss ambassador Jacques de Watteville to discuss “exchanges and cooperation in the field of pharmaceuticals, medical devices, cosmetics, and other regulatory matters.”

Swissmedic confirmed this, telling in-pharmatechnologist.com the talks were “preliminary discussions on a possible future cooperation between the Chinese and Swiss competent authorities,” but said that it is too early to provide additional information.

The meeting is an indication that – in keeping with polices set out by recently elected Communist Party General Secretary Xi Jinping – the SFDA is keen to forge closer ties with authorities outside China.

In the past few months the Beijing regulators have met with deputy US Food and Drug Administration Commissioner (FDA) Michael Taylor and Elena Telnova, acting head of Russia’s Roszdravnadzor, to discuss drug supervision and active pharmaceutical ingredient (API) testing.

In December, the SFDA was visited by Health Canada to discuss drug supervision and exchange opinions on GMP, monitoring of adverse reactions, experience on joining PIC/S, supervision on traditional Chinese medicines and supervision system of international drug regulatory agencies.

API imports

The timing of the Swissmedic meeting is interesting given that it comes just six months before manufacturers shipping APIs to the Europe Union will be required to provide written confirmation of quality from local regulators under the Falsified Medicines Directive (FMD)

Manufacturers in China supply a significant proportion of the APIs used in Europe, which is a cause for concern among some regulators including the UK MHRA.

In December , the UK drug watchdog said that China’s position on the new import laws was unclear and warned of potential shortages if APIs made in the country lacked the required confirmation documents from the SFDA.

In the weeks since the SFDA has launched a study of its API industry which, while unlikely to convince organisations like the European Fine Chemicals Group (EFCG) of the merits of the FMD approach to regulation , was an indication the Chinese authorities at least acknowledge the new import laws.

To date Switzerland is the only country to be included on the third country list of non-EU states deemed to have comparable API manufacturing standards, which means Swissmedic is not required to provide written confirmation of quality.

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