Ref: PXL/H.O./CIR-004/2017-18 Date: 12.04.2017
Dear Sir / Madam
Subject: Public comments invited by China Food & Drug Administration (CFDA) on Draft Notification - "Decision on Adjusting Matters Concerning the Registration Management of Imported Drugs" by 20th April 2017.
Members are kindly aware Council has represented issues pertaining to delayed product registrations, high registration fees, testing of samples with MoC and Embassy earlier and our Mission in China is also continuously pursuing with CFDA authorities on the subject matter.
In this context, it is to bring to your kind notice that CFDA has brought a draft notification titled "Decision on Adjusting Matters Concerning the Registration Management of Imported Drugs" seeking comments on the draft rules concerning the registration and management of imported drugs in China.
The new draft rules include the following important provisions:
1. The requirement that a drug must have been registered for sale in other countries or have entered Phase II or III of clinical trials before being considered for registration in China has been done away with. Instead of this, new drugs (except vaccines) can opt for registration upon completion of an international multi-center clinical trial (IMCT) in China
2. The requirement that a new chemical drug or therapeutic biological drug must be approved for sale in its native country or the native country of its manufacturer before being considered for registration in China has been done away with.
The subject draft notification is open for public comments till 20th April 2017. We, therefore, request member companies to please go through the attached draft notification and submit your comments before 20th April 2017.
Members submitting comments to please send email to email@example.com and name the title as "Opinions on adjusting matters concerned in registration management of imported drugs" with a copy to our Embassy in China at firstname.lastname@example.org and email@example.com.