China Pharmaceutical Regulatory Updates | July 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. China\’s 7th Volume-based Procurement Includes 327 Drug Products On July 18, China National Joint Drug Procurement Office announced the official list of 327 drug products for the 7th volume-based procurement (VBP). 217 bid-winning companies 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 China Announces Final Result of the 7th Volume-based Procurement (VBP) for Drugs for more details. China NMPA Grants One Rx-to-OTC Switch On July 11, China NMPA granted the OTC status to…

Aug. 10th, 2022

FAQs on Drug Registration Applications & Clinical Trials | China CDE

For frequently asked questions concerning technical issues, China Center for Drug Evaluation (CDE) releases corresponding answers on its website. For further enquiries about drug registration, please contact BaiPharm for professional help. This article covers the Q&As on the first two topics. Q&As on other topics will be released soon. Please stay tuned. 1. The Submission and Acceptance of Drug Registration Applications; 2. Clinical trials 3. Bioequivalence (BE) Study 4. Selection of Reference Listed Drugs 5. Quality and Therapeutic Equivalence Evaluation for Generic Drugs 6. R&D Requirements for Biological Products 7. Associated Review and Approval of APIs, Excipients, and Packaging Materials 8. Administration and Requirements for Variations 9. Others Part 1. The Submission and Acceptance of Drug Registration Applications Q1: According to CDE\’s Notice of Adjusting the Acceptance Methods and the Application Document Requirements During COVID-19 Pandemic, should the applicant submit electronic application documents if the submission is after Feb. 7, 2022? A1: If the applicant has…

Aug. 09th, 2022

New Drug Approvals in China | July 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. Related Articles: China Chemical Drug Registration Classification China Biological Product Registration Classification Expedited Programs for Drug Registration in China In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech\’s Azvudine Tablets is the first homegrown oral drug to get NMPA\’s approval for…

Aug. 08th, 2022

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
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