July pharmaceutical event policy article: the pharmaceutical industry will welcome further standardized development.

The series of pharmaceutical policies issued and implemented in July includes drug safety, drug supervision, medical insurance and other aspects, as well as medical devices, biological products and other aspects.
these policies on the pharmaceutical industry are not only conducive to better maintenance of drug safety, but also conducive to further standardize the development of the pharmaceutical industry, to create a better drug environment.
July 2, 2020 edition of the Chinese Pharmacopoeia promulgated, the State Drug Administration and the National Health and Safety Commission issued a public announcement, the official promulgation of the 2020 edition of the Chinese Pharmacopoeia, the official implementation date is scheduled to be December 30 this year.
5,911 new pharmacopeias, an increase of 5.5% over the 2015 edition of 5608.
than the last version of the pharmacopeia, the 2020 edition of the pharmacopeia for drug safety control requirements have been further strengthened.
is particularly evident in the safety control requirements for Chinese medicine, chemicals and biological products.
with the implementation of the new edition of the Pharmacopeia, will affect the entire pharmaceutical industry, to ensure the quality of drugs, maintain public health, promote the development of high-quality pharmaceutical industry play an important role.
the use of non-degradable plastic shopping bags in late July, nine departments jointly issued a "notice on solidly advancing the management of plastic pollution."
Notice proposed that, from January 1, 2021, the use of non-degradable plastic shopping bags will be prohibited in shopping malls, supermarkets, pharmacies, bookstores and other places in the municipalities directly under the Central Government, provincial capital cities and planned single-listed cities, as well as in various exhibition activities, but the use of roll bags, fresh bags and garbage bags will not be prohibited.
the end of July, China issued the Implementation Opinions on Further Optimizing the Business Environment and Better Service Market Subjects.
It clearly states that, under the premise of ensuring medical safety and quality, we will further relax the scope of Internet medical treatment, include qualified Internet medical services in the scope of medical insurance reimbursement, formulate and publish uniform Internet medical approval standards, speed up the review and approval of innovative medical devices and promote clinical application.
The industry believes that the "Opinion" will be the Internet medical services into the scope of medical insurance reimbursement, the formulation of the publication of a unified national Internet medical approval standards, that is, the Internet medical treatment this new business is fully affirmed, but also to optimize the Internet medical market, to support the development of Internet medical reality needs.
"On the issuance of the key tasks in the second half of 2020 to deepen the reform of the medical and health system" issued July 23, "on the issuance of deepening the reform of the medical and health system in the second half of 2020 key tasks" was officially issued.
the notice mentioned that in the second half of the year, efforts should continue to be made to promote the transformation of disease treatment as the center into people's health as the center, deepen the reform of medical care, medical insurance and medicine linkage, and continue to focus on solving the problem of difficult and expensive medical care.
The provisional import tax rate adjustment for medical devices in 2020 According to the "Provisional Import Tax Rate 2020" adjustment plan, from July 1 to December 31, 2020, more than 20 kinds of medical device products, including endoscopy, kidney dialysis equipment (artificial kidney) and so on, the import tax rate was reduced to 0.7% and below.
on the registration classification of biological products and chemicals from July 1, 2020, the classification of biological products and chemicals registration officially implemented.
the declaration requirements for both will come into effect on 1 October 2020.
, by September 30, 2020, the company may submit the declaration as originally requested.
the implementation of the quality management norms for drug clinical trials, both of which are core supporting regulations in the field of drug supervision, were officially implemented on July 1, 2020.
From the content point of view, it mainly includes: comprehensively encouraging drug research and development innovation, clarifying the main responsibility of enterprises, optimizing the review and approval process, as well as clarifying the national and provincial drug regulatory departments in the drug registration management and day-to-day supervision of the division of authority and supervision and inspection requirements.
new version of GMP Appendix "Biological Products" will come into effect on July 1, 2020.
In terms of content, there are eight chapters and 63 articles, compared with the old version of the "Biological Products" appendix, which came into effect on March 1, 2011, the addition of six new articles, the revision of 15 articles, the addition of additional provisions mainly around the further strengthening of vaccine management, regulate vaccine production and quality management behavior.
new version of the Drug Clinical Trial Quality Management Code released a new version of the Drug Clinical Trial Quality Management Code in the overall framework and chapter content than the current GCP has made a significant adjustment and addition.
the overall framework structure, the number of words increased from more than 9000 words to more than 29,000 words, the chapter from the original 13 chapters 70 to 8 chapters 84.
addition and refinement of the terminology clause, from the original 19 to 40, while the term and its definition forward to chapter II, to facilitate the reader's reading and understanding of the normative content.
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