Deadline of July 2nd, 2013 on API imports into Europe comes across – latest update and related references!

Hereby the latest update of the current status concerning the preparation of affected Non-EU Countries for API imports into Europe after July 2nd 2013 is given:

Countries listed as accepted for exemption (no need for “written confirmation”)

  • Switzerland (adopted 23.11.2012)
  • Australia (adopted 25.04.2013)
  • Japan (adopted 05.06.2013)
  • USA (adopted 21.06.2013)

Brazil, Canada, China, India, Israel, Mexico, Singapore, South Africa, South Korea, and Ukraine are said to issue written confirmations (Brazil, Israel and Singapore had applied to be listed for exemption, but are not adopted yet, due to several reasons).

China will only issue “written confirmations” for those manufacturers, which have been subject to on-site GMP inspections. The Chinese CFDA issued instructions to the provinces authorities on May 7th with accompanying forms on the requirements for certifying API manufacturers accordingly. Under two scenarios an API will be granted written confirmation: (a) company with production licence & drug approval number (b) company with production licence but no drug approval number at the time being.  Once written confirmation is issued, the province level CFDA will pass on this information to the CFDA headquarters in Beijing.  All written confirmation data will be updated in a database and published to public accordingly. If a site does not comply with the current GMP requirements or does not comply with the conditions for certification, local authorities must inform CFDA headquarters within 24 hours so that the information can be forwarded to the EU.

In India the Central Drugs Standard Control Council (CDSCO) has published a database of companies with issued written confirmations.

EXCiPACT – the pilot phase including witnessing of auditors and certification bodies will be completed soon

EXCiPACT, the certification scheme developed from an initiative of industrial associations of excipient and pharma suppliers, has completed several audits in the pilot phase. Thereby the provisional auditors have been witnessed during their first EXCiPACT audit by an EXCiPACT representative.  This is to ensure consistency in understanding of the standard and its application. The first fully approved EXCiPACT auditors have now been listed on the website of EXCiPACT:

Global alliance for Drug quality founded with China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE)

Effective 1st June 2013, the China Pharmachamber (Chamber of Commerce for Import & Export of Medicines & Health Products) and the German GMP 3rd party auditor blue inspection body GmbH have formed a strategic co-operation. Its primary goal is to support Chinese manufacturers of drug products and active ingredients (APIs) in the framework of their quality management system (QMS) to comply with European GMP regulations. Invited by the CCCMHPIE, GMP auditors from blue inspection body will introduce the specifics of EU GMP regulations and differences to the CFDA standards to Chinese enterprises. In addition, the member companies of CCCMHPIE will be offered to host so-called mock audits by blue inspection body. The Chinese manufacturers can thereby assess whether their QMS already complies with the EU GMP regulations or at which occasions the processes may need to be adjusted accordingly. During this years’ CPhI China in Shanghai (June 25th – 27th) the co-operation was inaugurated.

Major GxP Events II & III/2013