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China Seeks Public Advice on Colorant Standards of Drug Excipients [English Form Available]

On July 11, the Chinese Pharmacopoeia (ChP) Commission announced that it would conduct systemic research on the standards of colourants as pharmaceutical excipients, in an effort to improve drug safety and quality controllability. The ChP Commission is currently asking for public advice on colourant standards. The target colourants include but are not limited to Colourants used in pediatric drugs; Colourants widely used in pharmaceuticals; Colourants whose current quality control standards are incomplete, especially for operation; Colourants whose current standards cannot meet the need for medical use. Colourants not included in the Chinese Pharmacopoeia are also open for public comments. If you have any relevant advice and comments, please fill in the following table and send it as an Excel file to sunjian_0000@163.com before August 20, 2022. Advice on the Pharmaceutical Excipient Standards of Colorants Name of the Pharmaceutical Excipient The Currently Effective Standard Problems with the Currently Effective Standard Whether …

Jul. 21st, 2022

Breaking! Immediate Effect of China\’s Vaccine Manufacture & Distribution Rules

On July 8, China National Medical Products Administration (NMPA) released the Administrative Rules on Vaccine Manufacture and Distribution (hereafter referred to as the Rules) with immediate effect. According to the Rules, China adopts marketing authorization holder (MAH) system for vaccines. MAHs shall take the primary responsibilities for vaccine\’s safety, efficacy, and quality controllability, and manage the manufacture and distribution of vaccines after obtaining marketing authorization.1 The Rules applies to the vaccine\’s manufacture, distribution, and supervision in China. Since overseas companies cannot entrust vaccine production activities to Chinese manufacturers, the manufacturing requirements in the Rules only apply to Chinese MAHs. As for vaccine distribution, overseas MAHs should obey the following requirements: The Sales of Vaccines 1. Overseas MAHs shall sell vaccines to disease prevention & control institutions as per purchase contracts. In principle, for one type of vaccines, overseas MAHs shall appoint only one drug supplier company to sell them. The supplier should be fully capable of ensuring the vaccine\’s quality with…

Jul. 18th, 2022

China Consults on 11 Packaging Material Standards in Pharmacopoeia

On July 13, the Chinese Pharmacopoeia (ChP) Commission released the drafts of 3 general chapters and 8 determination methods of rubber closures as pharmaceutical packaging materials. The draft is currently under consultation until August 13. Before that, comments on the general chapters can be sent to xujun@shpmcc.com and opinions on the testing methods can be sent to jiangyan@scsyjs.org. General Chapters 5200 Rubber Closures for Pharmaceutical Packaging 5201 Rubber Closures for Packaging Injections 5202 Rubber Closures for Packaging Oral Dosage Forms Determination Methods 4204 Determination of Extractables and Leachables of Pharmaceutical Packaging Materials 4206 Determination of Insoluble Particles in Pharmaceutical Packaging Materials 4214 Determination of Metal Elements and Ions in Pharmaceutical Packaging Materials 4219 Determination of Volatile Sulfide in Rubber Closures 4220 Determination of Ash Content in Rubber Closures 4221 Determination of Water Content in Rubber Closures 4222 Determination of Silicone Oil on the Surface of Rubber Closures 4223 Determination of…

Jul. 15th, 2022

327 Drug Products to Enter China\’s 7th Round of Volume-based Procurement (VBP)

On July 13, the National Joint Drug Procurement Office announced the preliminary result for the bid of the 7th round of volume-based procurement (VBP). 327 products (61 drugs if differentiated by active ingredients) owned by 217 companies won the bid in the preliminary stage. The bid-winning products cover 31 disease categories, including common and/or chronic diseases such as hypertension, diabetes, gastrointestinal disorders and severe diseases of lung/liver/kidney/colon cancer. The bid-winning products\’ prices were reduced by 48% on average. In terms of kidney cancer drugs, the average price of Lenvatinib Mesilate Capsules was cut by 83.33% from 108 yuan/capsule to 18 yuan/capsule. Among drugs for treating high blood pressure, Nifexdipine Controlled-release Tablets\’ average price dropped by 58% and Metoprolol Succinate Sustained-Release Tablets\’ by 53%. Of the 327 products, six are from international pharma companies and their VBP prices are listed below. Drug Product Specification Company VBP Price Oseltamivir Phosphate Capsules 75mg*10 capsules per…

Jul. 15th, 2022

327 Drug Products to Enter China\’s 7th Round of Volume-based Procurement (VBP)

On July 13, the National Joint Drug Procurement Office announced the preliminary result for the bid of the 7th round of volume-based procurement (VBP). 327 products (61 drugs if differentiated by active ingredients) owned by 217 companies won the bid in the preliminary stage. The bid-winning products cover 31 disease categories, including common and/or chronic diseases such as hypertension, diabetes, gastrointestinal disorders and severe diseases of lung/liver/kidney/colon cancer. The bid-winning products\’ prices were reduced by 48% on average. In terms of kidney cancer drugs, the average price of Lenvatinib Mesilate Capsules was cut by 83.33% from 108 yuan/capsule to 18 yuan/capsule. Among drugs for treating high blood pressure, Nifexdipine Controlled-release Tablets\’ average price dropped by 58% and Metoprolol Succinate Sustained-Release Tablets\’ by 53%. Of the 327 products, six are from international pharma companies and their VBP prices are listed below. Drug Product Specification Company VBP Price Oseltamivir Phosphate Capsules 75mg*10 capsules per…

Jul. 15th, 2022

H1 2022: Top 12 China Generic Drug Approval Winners

In the first half of 2022, China National Medical Products Administration (NMPA) approved 210 domestically-manufactured generic drugs for marketing authorization. Overview of the Top 12 Companies Yangtze River Pharmaceutical is the biggest winner, owning 14 approved generic drugs, followed by Sichuan Kelun Pharmaceutical and Beite Pharmaceutical with 11 approved generics respectively. Jiangsu Hengrui Pharmaceutical takes the fourth and fifth places with 9 generic products and CSPC Pharmaceutical with 8 generics. Ranking Company Approved Generic Drugs Approved Generic Drug Applications 1 Yangtze River Pharmaceutical 14 18 2 Sichuan Kelun Pharmaceutical 11 18 2 Beite Pharmaceutical 11 15 4 Jiangsu Hengrui Pharmaceuticals 9 12 5 CSPC Pharmaceutical 8 12 6 CR Pharmaceutical 7 7 6 SSY Group 7 7 8 Reyoung Pharmaceutical 6 8 9 Qilu Pharmaceutical 5 7 9 Easton Biopharmaceuticals 5 6 9 Sino Biopharmaceutical 5 5 9 Tianyu Pharm 5 5 Data source: Menet.com.cn * Notes: The approved generic…

Jul. 14th, 2022

New Drug Approvals in China | June 2022

Editor\’s Notes: New drugs in this article refer to Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China; Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China; First generic drugs in China. *\”First generic drug in China\” refers to the first generic drug developed by Chinese companies and approved by China National Medical Products Administration (NMPA). Technically, generic drugs are not innovative/improved drugs according to Chinese drug regulations. Yet, first generics are still included in this article because they are new in the Chinese market. In June 2022, China NMPA approved 25 new drugs, including 17 chemical drugs and 8 biological products. 1. Jiangsu Hengrui Pharmaceuticals\’ SHR3680 Tablets; 2. Bayer\’s Finerenone Film-coated Tablets (Kerendia); 3. Qilu Pharmaceutical\’s Aripiprazole Oral Soluble Film; 4. Qilu Pharmaceutical\’s Memantine Hydrochloride Oral Soluble Film; 5. Boehringer Ingelheim\’s Empagliflozin Tablets; 6. Jiangsu Hengrui Pharmaceuticals\’ Pyrotinib Maleate Tablets; 7. Shenzhen China Resources…

Jul. 12th, 2022

Updates on Pharmaceutical Regulations in China | June 2022

This is a collection of China\’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities: National Medical Products Administration (NMPA); NMPA\’s Center for Drug Evaluation (CDE); National Health Commission (NHC); National Healthcare Security Administration (NHSA); National Joint Drug Procurement Office; Chinese Pharmacopoeia (ChP) Commission. For more details about the summarized contents below, please send an enquiry to contact@chemlinked.com. 1. CDE Issues the 2021 China Drug Evaluation Report On June 1, CDE issued the 2021 China CDE Drug Evaluation Report, revealing that 47 innovator drugs were approved in 2021. BaiPharm has selected critical information and compiled it into a report, which covers the following information: The accepted, reviewed, and approved drug applications; The expedited approvals; Onsite inspections; Approved medical products in significant therapeutic areas; Disapproval reasons; Reforms of the drug review & approval system. ChemLinked BaiPharm members can download the report for free at BaiPharm Insight. (Read More) 2. CDE Publishes…

Jul. 08th, 2022

2021 China CDE Drug Evaluation Report is Out!

On June 1, China Center for Drug Evaluation (CDE) released the 2021 China Drug Evaluation Report. ChemLinked BaiPharm Team selected excerpts from the report to help pharmaceutical companies understand the data and reform trends of China\’s drug review and approval. ChemLinked BaiPharm Report contains the significant data of drug evaluation. The report can be downloaded for free at the bottom of this page. Contents 1. Acceptance of Applications 1.1 Overview of Applications 1.2 Acceptance of Innovator Drug Applications 1.3 Accepted TCM Applications Requiring Technical Review 1.4 Accepted Chemical Drug Applications Requiring Technical Review 1.5 Accepted Biological Product Applications Requiring Technical Review 2. Review of Applications 3. Approval of Applications 3.1 Overview of Approval/Recommended Approval 3.2 Approval of Innovator Drug Applications 3.3 Approval/Recommended Approval of TCM Applications 3.4 Approval/Recommended Approval of Chemical Drug Applications 3.5 Approval/Recommended Approval of Biological Product Applications 4. Expedited Approval 4.1 Breakthrough Therapy Designation (BTD) 4.2 Conditional Approval (CA)…

Jul. 05th, 2022

China Stresses Rare Disease & Pediatric Drugs in Adjusting the 2022 National Reimbursement Drug List

On June 29, 2022, China National Healthcare Security Administration (NHSA) issued the Work Plan for Adjusting the 2022 National Reimbursement Drug List (NRDL) (hereafter referred to as NRDL). NRDL is a list of drugs covered by the basic national insurance for healthcare, employment injury, and maternity. 1. Which Drugs Can Apply for Entering NRDL The Work Plan specifies the six conditions1 that drugs can apply for entering NRDL: Drugs approved by National Medical Products Administration (NMPA) with new generic names between January 1, 2017, to June 30, 2022. Drugs with major indication changes approved by NMPA between January 1, 2017, to June 30, 2022. Drugs in the latest version of COVID-19 Pneumonia Diagnosis and Treatment Plan. Drugs in the 2018 National Essential Drug List. Drugs in the Encouraged Generic Drug List / List of Pediatric Drugs Encouraged for R&D and Application and approved by NMPA before June 30, 2022. Rare disease drugs (orphan drugs) approved by NMPA before June 30, 2022….

Jul. 04th, 2022

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