PXL/HO/Cir-005/2018-19 Dt: 04.05.2018
Subject: Delay in product registrations by China Food & Drug Administration (CFDA), China-Reg
Members are kindly aware, Council has represented the issue of delay in the product registrations by FDA, China at various platforms and requested Department of Commerce to take up the matter with the officials of CFDA, China.
We would like to bring to the notice of the member companies that the subject issue has been discussed at highest level and requested Pharmexcil to inform the number of applications pending with CFDA, China and reasons for such pendency.
In this context, we request members to please share the following details for taking up the matter with Department of Commerce accordingly:
1) Name of the Company
2) Number of Product registration applications filed by your company with CFDA during last two years
3) Number of applications pending with CFDA as on date
4) Reasons cited by CFDA for the pendency
We would request members to send the details at the earliest for enabling the Council submitting to the Department of Commerce.