GMP News: APIs from China and India - will Import go down in 2013?

APIs produced in third countries in Asia (like China and India) can only be imported into the EU if the regulatory authority of the exporting country issues a written confirmation that those APIs have been manufactured in GMP-compliant conditions which comply with the European regulations. Moreover, the statement must also comply with the European regulations and ensure that information about non-Compliance shall be immediately reported by the authority of the third country to the EU.

We already reported about the EU Commission proposal to introduce a template for the written confirmation of GMP Compliance (GMP News dated 3. May 2012).

It seems that neither authorities operating in the Indian provinces nor those operating in Chinahave recognised the requirement of the EU and taken adequate measures. Although the API industry in India is concerned by the new requirement, no measure has been taken. As a consequence, some APIs might not be available in 2013. This scenario has already been raised by different industry organisations. Now the British Authority (MHRA) has also expressed their concern.......

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GMP News: APIs from China and India - will Import go down in 2013?