-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
01.
Normalize centralized procurement
Normalize centralized procurement
On January 28, 2021, the "Opinions of the General Office of the State Council on Promoting the Normalized and Institutionalized Development of Centralized and Volumetric Procurement of Drugs (Guobanfa [2021] No.
2)" was released, explaining that centralized and volumetric procurement of drugs was used as a coordinated promotion of pharmaceutical services Important measures for supply-side reforms will be further expanded and normalized.
It is clear that drugs with large amounts and high purchase amounts in the basic medical insurance drug catalogue will be included in the procurement scope, guide drug prices to return to a reasonable level, and effectively reduce the burden on the public to use drugs, and promote the health of the pharmaceutical industry Develop and promote the reform of public medical institutions to better ensure that the people are treated for their illnesses
.
02.
Release of the first departmental regulations and documents specifically for post-marketing change management of drugs
Release of the first departmental regulations and documents specifically for post-marketing change management of drugs
On January 13, 2021, the State Food and Drug Administration issued the "Administrative Measures for Post-Marketing Changes of Drugs (Trial)" to regulate drug marketing authorization holders (referred to as holders) on the post-marketing changes of drugs.
This is China’s first specifically targeted at drug listings.
The regulatory documents formulated after the change
.
The "Measures" closely follow the legislative purposes and relevant provisions of the "Drug Administration Law", "Vaccine Administration Law", "Drug Registration Administration Measures", and "Drug Production Supervision and Administration Measures", link up the systems, clarify the management requirements for changes after the drug is marketed, and provide regulations The holder bears the main responsibility for the post-marketing change of the drug, integrating the requirements of drug registration and production supervision on post-marketing changes, integrating the entrusted production, changing (increasing) the production site, etc.
, and changing the drug production site from the production license, The "multi-head tandem handling" of registration changes and on-site inspections has been transformed into "one thing combined management"
.
03.
The General Office of the State Council issued "Several Policy Measures on Accelerating the Development of Traditional Chinese Medicine"
The General Office of the State Council issued "Several Policy Measures on Accelerating the Development of Traditional Chinese Medicine"
On February 9, 2021, the General Office of the State Council issued a notice on "Several Policies and Measures for Accelerating the Development of Traditional Chinese Medicine with Characteristics" to explore medical insurance payment methods that meet the characteristics of traditional Chinese medicine, publish advantages in traditional Chinese medicine, and encourage the implementation of traditional Chinese medicine with the same disease and the same effect.
Same price
.
The notice proposes specific details from seven aspects, including consolidating the talent base of traditional Chinese medicine, improving the vitality of the development of the traditional Chinese medicine industry, strengthening the development momentum of traditional Chinese medicine, improving the system of integrated traditional Chinese medicine and western medicine, implementing major projects in the development of traditional Chinese medicine, improving the benefits of traditional Chinese medicine development, and creating a good environment for the development of traditional Chinese medicine.
04.
The trial of traditional Chinese medicine formula granules ends, and the record management is implemented
The trial of traditional Chinese medicine formula granules ends, and the record management is implemented
The Announcement (No.
22 of 2021) of the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the National Health Commission, and the National Medical Insurance Bureau on the end of the pilot work of Chinese medicine formula granules was issued on February 10, 2021, ending the 20-year-old Chinese medicine formula granules In the pilot work, it is stipulated that the varieties of traditional Chinese medicine formula granules shall be subject to record management, and the approval number management shall not be implemented.
The manufacturer shall report to the local provincial drug supervision and administration department for record before the listing
.
The quality supervision of Chinese medicine formula granules is included in the management of Chinese medicine decoction pieces, and its policies on clinical use, price, medical insurance payment and other aspects are researched and formulated or clarified by relevant departments
.
This positioning highlights the subjectivity of Chinese herbal medicine pieces
05.
The General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Supervision"
The General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Supervision"
On May 10, 2021, the General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Supervision" (hereinafter referred to as the "Implementation Opinions")
.
It was pointed out that drug safety is related to the health and life safety of the people, and 18 key tasks in six areas were clarified
Adhere to the people first and life first, implement the "four strictest" requirements, deepen the reform of the review and approval system, continue to promote regulatory innovation, strengthen the construction of regulatory teams, accelerate the establishment of a scientific, efficient and authoritative drug regulatory system, and resolutely maintain drug safety The bottom line is to further improve the scientific, legal, international, and modern level of drug supervision, and promote China's leap from a major pharmaceutical country to a powerful pharmaceutical country, so as to better meet the people's needs for drug safety
.
06.
Release of the first regulatory document for the field of pharmacovigilance
Release of the first regulatory document for the field of pharmacovigilance
On May 13, 2021, the National Food and Drug Administration issued the "Pharmacological Vigilance Quality Management Standards", which will be officially implemented on December 1, 2021
.
This document is the first pharmacovigilance supporting document of the newly revised "Drug Administration Law", which is used to regulate and guide the pharmacovigilance activities of drug marketing authorization holders and drug registration applicants
07.
Sinopharm Zhongsheng Beijing Company and Kexing Zhongwei Company's new crown inactivated vaccines are included in the emergency use list of the World Health Organization
Sinopharm Zhongsheng Beijing Company and Kexing Zhongwei Company's new crown inactivated vaccines are included in the emergency use list of the World Health Organization
At 23:00 on May 7, 2021, the World Health Organization held a press conference.
Director-General Tan Desai announced that the new crown inactivated vaccine developed by Sinopharm Beijing Co.
, Ltd.
will be included in its emergency use list
.
On June 1, 2021, the World Health Organization held a press conference.
Director-General Tan Desai announced that the new crown inactivated vaccine developed by China Kexing Zhongwei will be included in its emergency use list
.
08.
Anti-monopoly guidelines of the Anti-monopoly Committee of the State Council on the field of APIs
Anti-monopoly guidelines of the Anti-monopoly Committee of the State Council on the field of APIs
On November 18, 2021, the National Anti-Monopoly Bureau was established.
On the same day, the Anti-Monopoly Committee of the State Council issued the "Guidelines for Anti-Monopoly in the Field of APIs", in order to prevent and stop monopolistic activities in the field of APIs, further clarify market competition rules, and safeguard raw materials The order of market competition in the pharmaceutical field protects the interests of consumers and the public interest of society
.
09.
National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List (2021)
National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List (2021)
On December 3, 2021, the notice of the National Medical Insurance Administration and the Ministry of Human Resources and Social Security on the issuance of the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2021)" (Medical Insurance Fa [2021] No.
50) was issued.
In this adjustment, a total of 74 drugs were added to the catalog and 11 drugs were removed from the catalog
.
Judging from the negotiation situation, the negotiation of 67 kinds of exclusive drugs out of the catalogue was successful, with an average price reduction of 61.
71%
.
After the adjustment, the total number of drugs in the National Medical Insurance Drug List is 2,860, of which 1,486 are Western medicines and 1,374 are Chinese patent medicines
10.
The first approved new coronavirus neutralizing antibody combination therapy drug with independent intellectual property rights
The first approved new coronavirus neutralizing antibody combination therapy drug with independent intellectual property rights
On December 8, the National Medical Products Administration approved Tengsheng Huachuang Medical Technology (Beijing) Co.
, Ltd.
's new coronavirus neutralizing antibody combined therapy drug Ambavirimab Injection (BRII-196) and Romisvirimab Application for registration of injection (BRII-198)
.
This is China's first approved new coronavirus neutralizing antibody combination therapy with independent intellectual property rights
According to the relevant provisions of the "Drug Administration Law" and in accordance with the special drug approval procedures, the State Drug Administration will conduct emergency review and approval, and approve the combination of the above two drugs for the treatment of mild and common types with progression to severe (including hospitalization or death) Adults and adolescents (12-17 years old, weight ≥40kg) with high-risk factors, patients with new coronavirus infection (COVID-19)
.
Among them, adolescents (12-17 years old, weight ≥40kg) are eligible for conditional approval
