On July 2, 2020, the National Medical Products Administration (NMPA) and the National Health Commission of the People’s Republic of China (NHC) announced the Chinese Pharmacopoeia 2020 Edition. Read NMPA announces the implementation of the Chinese Pharmacopoeia 2020 edition This is the 11th edition of Chinese Pharmacopoeia and will be officially implemented from December 30,…
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…
In order to ensure the smooth implementation of the newly revised “Provisions for Drug Registration”, National Medical Products Administration (NMPA) is currently stepping up the upgrading digital systems for drug registration. The relevant matters are now announced as follows: 1.On June 24, 2020, the NMPA government website will release a new version of the drug…
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…
Background It has been almost 13 years since the implementation of China’s “Provisions for Drug Registration” (SFDA Order No.28) on Oct 1st, 2007. Over the past ten years, these provisions have played a very important role in ensuring drug’s safety, efficacy and controllable quality, and regulating behaviors in drug registration. But with the continuous improvement…
In the first quarter of 2020, the National Medical Products Administration (NMPA) approved a total of 11 new drugs including 6 imported drugs and 5 domestic drugs. Among them, domestic medicines also have a vaccine and a traditional Chinese medicine as the table below shows. Note: Here the NDAs are the drugs approved by NMPA…
