THE FIRST FACE TO FACE
COMMUNICATION GUIDANCE MEETING WITH THE GUANGDONG-HONG KONG-MACAO GREATER BAY AREA CENTER FOR DRUG EVALUATION AND INSPECTION OF NMPA COMPLETE SUCCESS
In order to implement the relevant provisions of the “Measures for the Administration of Drug Registration” on “in the process of drug development and registration, drug regulatory departments and their professional technical institutions shall provide necessary technical guidance, communication, priority allocation of resources, shortening of the time limit of evaluation and other policies and technical support”, and give full play to the communication and guidance function in advance, On April 29,Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection of NMPA (hereinafter referred to as the Sub-center) launched the filing guidance service for pharmaceutical research and development enterprises and institutions in the region.
On the morning of May 23, a face-to-face communication and guidance meeting was held with the Sub-center before the declaration of IND for Tangningtongluo Tablets, a class 1.1 new traditional Chinese medicine for treating diabetic retinopathy (DR) in our company.We introduced the new drug development process, the current progress preparation and follow-up plan to the main leaders of the Sub-center and the reviewers of various disciplines. In response to the specific problems raised by us in the application , the Sub-center center has made targeted replies, cracked the questions, clarified the ideas, and pointed out the direction.
In the future, we will actively strengthen communication with the Sub-center, get more guidance, so that the R & D route will take fewer detours, and constantly promote the progress of research and development step by step.
