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.