The new version of China’s “Drug Administration Law” has gone into effect since December 1st, 2019, which indicates a major step forward in China’s reformation of administration laws for drug products. Meanwhile, the National Medical Products Administration (NMPA) released the new version of “Provisions for Drug Registration” (hereinafter referred to as the New Provisions) and…
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…
