On April 30, 2020, China NMPA and CDE have issued a number of draft policies for public review relating to China drug registration. The policies announced have obviously favorable benefits for clinical needed overseas innovative new drugs, improved drugs, traditional Chinese medicine compound preparations and high-end generic drugs. And a series of improved procedures make…
Q9: What is the difficulty for imported OTC products entering the China pharma market? Will the new “technical guidelines and procedures for OTC marketing and registration” mentioned in the new “Provisions” provide a better suited market entry for the registration of OTC? A: Under the current background of the classification of chemical drugs, it’s unlikely…
Recently, China Center for Drug Evaluation (CDE) has received feedback from overseas companies regarding Covid-19 impacts on drug application submissions; these impacts have included impact from closure of foreign embassies, travel disruption and international delivery services. As a result, required documentation could not be notarized, certified and delivered timely. Taking in to account the important…
