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Manufacturing Entrustment: Key Points Under China\’s Marketing Authorization Holder (MAH) System

From July 22 to 23, the first International MAH Collaboration & Innovation Summit took place in Hangzhou, Zhejiang Province. More than 60 experts, scholars, and drug regulatory officials shared their insights on China\’s drug marketing authorization holder (MAH) system. One of the most heated topics is manufacturing entrustment under the MAH system. The MAH system was first piloted in China in 2015 and officially implemented in 2019. It allows MAHs to entrust manufacturing activities to other companies. Benefiting from manufacturing entrustment, research institutions/companies can focus their capital and technology more on drug R&D instead of expanding production capacity. Besides, contract manufacturing organizations can make the best use of their production capacity while carrying out the entrusted manufacturing tasks. With regard to manufacturing entrustment, speakers at the summit interpreted relevant regulations and offered their advice to companies on regulatory compliance. BaiPharm has collected the key points as follows. Prerequisites for Marketing Authorization:…

Jul. 29th, 2022

China Approves First Domestic Oral Drug for COVID-19

On July 25, China National Medical Products Administration (NMPA) granted conditional approval to Chinese domestic company Genuine Biotech\’s Azvudine Tablets for treating COVID-19 pneumonia.1 Azvudine\’s Indication Azvudine was approved for treating HIV-1-infected adult patients in July 2021. Now the drug has a new indication for treating adult patients with the normal type of COVID-19 pneumonia. In China, COVID-19 pneumonia conditions are divided into four types clinically: mild, normal, severe, and critical. The normal type means that patients have a fever and/or respiratory symptoms that are related to COVID-19 pneumonia and presented in medical imaging. The patients have a normal or reduced total amount of white blood cells, including a normal or reduced amount of lymphocytes.2 Azvudine\’s Clinical Trial Result From phase II to phase III clinical trials, patients turn COVID-19-negative in 3-4 days after taking Azvudine at a daily amount of 5mg.3 According to the phase III clinical trial result,…

Jul. 28th, 2022

China Announces Final Result of the 7th Volume-based Procurement (VBP) for Drugs

On July 18, China National Joint Drug Procure Office announced the official list of 327 products for the 7th volume-based procurement (VBP). The 327 products are owned by 217 bid-winning companies, which will supply the products to public health institutions. Among the companies, 6 are international enterprises—Hetero Labs, Bracco Sine, Almirall, Sandoz, and Pfizer. Please refer to BaiPharm\’s previous report for their bid-winning products\’ detailed information, including prices. Therapeutic Areas of 327 Products in the VBP List The 327 products are classified into 60 categories based on the types and content ratios of active ingredients in finished dosage forms. Among the 60 categories, 12 categories are anti-infection medicines, such as Ornidazole Tablets, Clindamycin Phosphate Injection, and Roxithromycin Tablets; 3 categories are for hypertension; 3 for diabetes; 2 for non-small cell lung cancer. Other drugs\’ indications include influenza, thrombosis, seizures, pancreatic cancer, thyroid cancer, etc. Benefits and Limits of VBP Basically, VBP is a…

Jul. 25th, 2022

Update: China Consults on 46 Pharmaceutical Packaging Material Standards in Pharmacopoeia

Since June 10, 2022, the Chinese Pharmacopoeia Commission has issued the drafts of 46 pharmaceutical packaging standards according to the plan for compiling the Chinese Pharmacopoeia 2025 Edition. The Commission is currently collecting public advice and comments on the drafts until Sept 1, 2022. List of the 46 Pharmaceutical Packaging Material Standards No. Standard 1 9651 Guidelines on Biological Evaluation and Test Selection for Pharmaceutical Packaging Materials 2 9652 Guidelines on Inspections of Pharmaceutical Packaging Materials 3 5100 General Chapter on Glass Containers for Packaging Pharmaceuticals 4 5101 General Chapter on Glass Bottles for Infusion 5 5102 General Chapter on Glass Ampoules 6 5103 General Chapter on Glass Bottles for Injection 7 5104 General Chapter on Glass Components in Pencil Injectors 8 5105 General Chapter on Pharmaceutical Glass Bottles 9 4003 Determination of Internal Pressure of Glass Containers; 10 4017 Determination of Internal Pressure Resistance of Glass Containers 11 4018 Determination…

Jul. 21st, 2022

Update: China Consults on 46 Pharmaceutical Packaging Material Standards in Pharmacopoeia

Since June 10, 2022, the Chinese Pharmacopoeia Commission has issued the drafts of 46 pharmaceutical packaging standards according to the plan for compiling the Chinese Pharmacopoeia 2025 Edition. The Commission is currently collecting public advice and comments on the drafts until Sept 1, 2022. List of the 46 Pharmaceutical Packaging Material Standards No. Standard 1 9651 Guidelines on Biological Evaluation and Test Selection for Pharmaceutical Packaging Materials 2 9652 Guidelines on Inspections of Pharmaceutical Packaging Materials 3 5100 General Chapter on Glass Containers for Packaging Pharmaceuticals 4 5101 General Chapter on Glass Bottles for Infusion 5 5102 General Chapter on Glass Ampoules 6 5103 General Chapter on Glass Bottles for Injection 7 5104 General Chapter on Glass Components in Pencil Injectors 8 5105 General Chapter on Pharmaceutical Glass Bottles 9 4003 Determination of Internal Pressure of Glass Containers; 10 4017 Determination of Internal Pressure Resistance of Glass Containers 11 4018 Determination…

Jul. 21st, 2022

China Seeks Public Advice on Colorant Standards of Drug Excipients [English Form Download For Free]

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

China Seeks Public Advice on Colorant Standards of Drug Excipients [English Form Download For Free]

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

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

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