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Chinese API plant oversight improving, but careful sourcing is key says EMA

By Gareth MacDonald+

08-Jul-2013

Chinese oversight of API plants is improving, but it is still important EU importers choose their sources carefully says European Medicines Agency (EMA) collaboration chief, Emer Cooke.

The EMA updated in-Pharmatechnologist.com on the state of play in China just a week after laws requiring that drug actives shipped to the European Union (EU) are accompanied by written confirmation of quality from regulators in the source country .

Emer Cooke, the EMA’s head of international and European cooperation told us the Chinese Food and Drug Administration (CFDA, previously the SFDA) - like regulators elsewhere – had been “very collaborative” in the run up to the July 2 implementation date.

On 7 May CFDA issued a notice to provincial offices giving details on the written confirmation to be issued, we are aware that at least 14 provincial offices have already issued written confirmations.

“CFDA have also indicated that it will implement an information system to collect the data and the EU will have access in a secured way to this database” Cooke continued.

No shortages

The EMA is also confident the new import rules will not result in shortages, which has been repeatedly raised by European drugmakers , industry groups and some regulators as a potential impact of the new requirements.

As with many pieces of new legislation, there is often some scepticism about whether it can be implemented effectively by the deadline outlined. In fact the new legislation specifically foresees measures to avoid shortages.”

She cited the waiver mechanism that frees API manufacturers of the written confirmation requirements if they are from countries in which quality regulations are deemed equivalent to those in Europe - to date granted to Australia, Japan, the US and Switzerland - as an example of the new import law’s flexibility.

The agency also conducted a risk assessment on the 30 per cent of centrally authorised medicines that use APIs from third countries to identify inspection priorities, which was shared with regulators in EU member states in advanced of the July 2 implementation date according to Cooke.

In the event of any possible risk of shortage, EMA is committed to working with the European Commission, the EU member states and regulators in non-EU countries to adopt pragmatic approaches, wither to obtain the written confirmation or to perform an expedited inspection.”

The EMA office told in-Pharmatechnologist.com that to date “we have no information yet of shipments being stopped because of [a lack of] written confirmations.” 

‘Chemicals’ plants

Despite this upbeat appraisal of the situation, the EMA has encountered some problems in China according to Cooke, particularly in relation to active pharmaceutical ingredient (API) producers that are classified as ‘chemicals manufacturers.’

One of the problems we are encountering is that some of the sites in China which are exporting active substances to the EU are classified in China as chemicals manufacturers, so they are not known to CFDA. For these sites it would be unreasonable to expect a written confirmation.

This highlights the importance of using manufacturers authorised/registered locally according to the rules and procedures of the country where they are located.”

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