Technical testing is an integral component of the medical device registration process in China. In October 2022, the China NMPA announced that the new Chinese standard related to the safety of electric medical devices – BG 9706.1-2020 – will come into effect on... Read More
On November 4, the NMPA released a draft regulation entitled “Announcement on the Administration of Chemical API Registration Renewal” and is seeking public comments by December 3. The announcement and regulation is expected to go into effect in one year. Before the... Read More
In 2020, the Chinese NMPA established the Rare Diseases Registry. Since then, more foreign and local drug companies have been interested in getting their rare disease drugs into China. According to GlobalData’s Drugs Intelligence Database, there are now 378 drugs for rare... Read More
According to the new Administrative Measures for Drug Recalls issued on October 26, 2022, Marketing Authorization Holders (MAHs) of drug products are responsible for drug recalls, not drug manufacturers. More specifically, hospitals, drug makers, and drug suppliers are only responsible for helping... Read More
Starting on November 1, 2022, China’s NMPA will issue electronic drug certificates for marketing authorization, clinical trials, drug renewals, chemical APIs, etc. The electronic certificate will be as valid as a paper certificate. To be eligible for electronic certificates, drug applicants must... Read More
According to GlobalData, Asia accounted for 50% of the world’s drug clinical trials over the last five years. The reasons for this include a large diverse population, improved healthcare institutions, lower costs, prevalence of certain diseases, etc. The number of clinical trials... Read More
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China’s State Administration for Market Regulation announced on September 1 new regulations of online drug sales. The regulation will be implemented on December 1 to strengthen and increase oversight. The Measures for the Supervision and Administration of Online Drug Sales includes 6... Read More
On July 27, in an effort to reinforce the management and use of pharmaceutical products in many fields, the National Healthcare Commission (NHC) issued the Notice on Further Strengthening Medication Safety Management and Improving the Level of Rational Medication. This notice put special emphasis on pediatric... Read More
As mentioned in previous newsletters, foreign drug and device companies can gain quicker access to China’s healthcare markets if they first register their products either on Hainan Island or in the Greater Bay Area. On Hainan Island, hospitals can apply for unregistered... Read More