In a surprise move, the China Food and Drug Administration (CFDA) has decided to scrap its license requirements for companies exporting pharmaceutical packaging material to China.
CFDA licenses are currently obligatory for all companies exporting pharmaceutical packaging material to China. The licenses are time-consuming and expensive to acquire and need to be renewed every five years. The renewal process alone can take between 12 and 18 months. But all this will soon be a thing of the past.
Constantia Flexibles was made aware of changes to the license system at the end of 2016, during the renewal of our blister foil license. The news came as a surprise to us, and the Chinese customers and agencies who assist us with our regulatory affairs.
Under the new regulation, packaging material suppliers no longer need to apply for the license. Instead Chinese companies importing the materials will be required to organize the necessary registration. All current licenses will expire on 31 December 2018 and be replaced by the new system in 2018.
What does this mean for our customers?
There is no need to change or re-register the products that are already registered on the basis of our licenses, as the current registrations will not expire. However from 1 January 2018 onwards, packaging materials and excipients documentation should be prepared according to the new regulation. This applies to any drug packaging materials and excipients that are intended for use with other drugs that are still undergoing clinical trials or at the production application phase.