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The implementation of the "Basic Medical Law" is imminent, and social medical services will welcome 5 major benefits!
Medicine Net, May 21 hearing, in just 10 days, that is, June 1, the first basic and comprehensive law in the field of health and health in my country, the Basic Medical Health and Health Promotion Law (hereinafter referred to as the "Promotion Law") ) will be implemented. Not long ago, the National Health and Medical Commission also issued a special document requesting study, publicity and implementation.
2021
05-21
CDE issued a document that overseas innovative drugs, improved drugs, etc. will usher in favorable policies
According to the guidance of the policy, whether it is to start multi-center clinical trials in China through overseas drugs, or to refer to the data of generic drugs from overseas listed drugs that are not listed in China, they are all promoting overseas clinically effective drugs. Speed up the domestic listing. For domestic innovative drug companies, it is clear that the competitive pressure will be more obvious.
05-19
Adjust the time and form of submission of supporting documents for imported drugs during the epidemic
On May 13, CDE issued a notice that due to the impact of the epidemic, when submitting an application for registration of imported drugs, notarized overseas documents could not be mailed or the supporting documents could not be notarized
05-14
The National Health Commission plans to stipulate that the new coronavirus samples should be stored in a centralized manner by designated institutions
According to the website of the National Health and Health Commission, the National Health and Health Commission recently drafted the "Notice on Laboratory Biosafety Supervision and Management in the Normalization of New Coronary Pneumonia Epidemic Prevention and Control (Draft for Comment)".
05-12
18 comments were sent out in succession! The detailed documents for drug registration are here
On April 30, the official website of the State Food and Drug Administration also posted 18 drafts for public comments, and the deadline for feedback is May 30, 2020.
05-06
The special rectification of illegal drug sales on the Internet has been further promoted
Pharmaceutical Network, April 26th, in order to implement the key tasks of post-marketing supervision of drugs in 2020, and comprehensively promote the special rectification of illegal drug sales on the Internet, on April 24, the Drug Supervision Department of the State Drug Administration presided over a meeting of illegal drug sales on the Internet.
04-26
The state issues new requirements for the precision of epidemic prevention and control in primary medical institutions
Medical Network, April 20th, urban and rural community medical institutions come here! The state has made precise and refined requirements for grass-roots epidemic prevention and control, and these tasks are closely related to everyone.
04-20
The National Health and Medical Commission issued a document: New tasks for primary medical institutions are here!
Medical Net, April 10th, the state has assigned new tasks, requiring primary medical institutions to set up new positions and complete these tasks!
04-10
Heavy New Deal: Over-evaluated generic drugs are not restricted by the proportion of drugs and auxiliary drugs!
On April 7, the CDE official website issued two notices in succession: "Notice on Public Solicitation of Opinions on <Guidelines for Clinical Trials of Trastuzumab Injection Biosimilars (Draft for Comment)>" and "Notice on Public Solicitation of Opinions on the Guiding Principles for Clinical Trials of Bevacizumab Injection Biosimilars (Draft for Comment)", plus the "On Public Solicitation of Adalimumab Injection Biosimilars" issued on April 1 Guidelines for Clinical Trials of Similar Drugs (Draft for Comment) > Notice of Opinions", the guidelines for clinical trials of biosimilars of three star drugs will be released soon.
04-09
Poor international transportation has become a bottleneck
Pharmaceutical Network, April 8 News The rapid spread of the new crown pneumonia epidemic around the world has caused a great impact on the production and supply chain of medicines. Some countries have reported that the supply of raw materials is tight. The relevant person in charge of the Ministry of Industry and Information Technology said that since the beginning of this year, the export volume of China's APIs has decreased year-on-year, with most products down by 10% to 20%, but there are also a few varieties of export volume that have increased year-on-year. International transportation has become a bottleneck restricting the export of APIs.
04-08
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