The oldtimers involved in the China market will recall the difficult times two decades ago when all suppliers were scrambling to get the newly required "Import Package Material for Drugs Licence" or "IDL". An extremely high level of detailed information was requested by CFDA and many eyebrows were raised internally on the need to submit such confidential data. The chinese language made the process even more challenging, but fortunately one of our multinational clients in Beijing generously offered to help with the translations.
Fast forward about 15 years and all pharmaceutical companies and suppliers were once again confronted with a totally new registration process. Now with the name CDE (Center for Drug Evaluation) under the umbrella of the NMPA (National Medical Products Administration). Many details and processes were unclear at the time of implementation and remained so for a lengthy period. For Perlen Packaging the timing was particularly critical, as we were in the middle of setting up our new state-of-the-art manufacturing facility in Suzhou.
The last few years have kept us busy submitting all the technical dossiers and studies for the various product structures and partnering pharmaceutical customers to carry out the "combined review" process, which is necessary to complete the registration. In the meantime, we are pleased to report that all our PERLALUX® main product groups (Mono PVC, Duplex PVC/PVdC, Tristar PVC/PE/PVdC) from our plants in China, Switzerland and Germany have obtained status "A" on CDE's online platform and can be viewed under www.cde.org.cn.
As the only foreign company manufacturing pharma grade blister films in China, we are well set up to supply this growing and demanding market. Please get in touch with your regular Perlen Packaging contact if you need any information relating to our CDE registrations.