Sept 2022: New Drug Approvals in China

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 September 2022, China\’s NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Nanjing Biosnwill Medical\’s Edaravone Sublingual Tablet AstraZeneca\’s Dapagliflozin Tablets Bayer\’s Rivaroxaban Tablets AstraZeneca\’s Olaparib Tablets Yichang…

Oct. 12th, 2022

Sept 2022 | China Pharmaceutical Regulatory Updates

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 customer@reach24h.com. Contents China SAMR to Permit Online Sales of Prescription Drugs Nationwide China NMPA Grants One Rx-to-OTC Switch China NMPA Releases 183 RLDs China CFDI Consults on Inspection Guidance for Blood Products China NHSA Announces 343 Drugs Passing the Format Review for NRDL China CDE Releases Pharmaceutical Guidelines Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline 1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide On Sept. 1, 2022, China State Administration for Market Regulation (SAMR) published the Administrative Measures for Supervising Online Sales of Drugs (hereafter…

Oct. 11th, 2022

How to Get China\’s Marketing Authorization for OTC Drugs

In China, the marketed drugs have been divided into prescription drugs (Rx drugs) and non-prescription drugs since 2000.Non-prescription drugs, also known as over-the-counter (OTC) drugs, can be bought and used without a prescription from a licensed physician. According to the health information and clinical research service provider IQVIA, China’s OTC drug market size is expected to grow from 244 billion yuan (circa US$35.39 billion) in 2021 to 306.1 billion yuan (circa US$44.4 billion) in 2025, with a compound annual growth rate of 5.3%. To enter such a market via general trade, OTC drugs usually need to go through complicated marketing authorization procedures that may last 2-3 years for drugs exempted from clinical trials, or even 4-5 years for drugs subject to clinical trials. This article discusses how to market OTC drugs in China via marketing authorization application or Rx-to-OTC switch. Contents 1. China\’s Marketing Authorization for OTC Drugs 1.1. NDA &…

Sep. 22nd, 2022

Carbon Peaking: China Issues Action Plan for Industrial Carbon Peaking by 2030

China unveiled its carbon peaking plan, highlighting six significant tasks and setting targets for seven key sectors, including steel, building materials, petrochemicals, nonferrous metals, consumer goods, equipment manufacturing and electronics. On August 1, 2022, China’s Ministry of Industry and Information Technology (MIIT), National Development and Reform Commission (NDRC), and Ministry of Ecology and Environment (MEE) jointly released the Carbon Peaking Action Plan for Industrial Sectors, in an effort to shift towards green and low-carbon industry and achieve carbon peaking by 2030. Six Major Tasks 1. Industrial Restructuring It is proposed to readjust the structuring of nonferrous metals, petrochemicals and steel sectors and form industry clustering with low-carbon sectors. The projects with high energy consumption and emissions are expected to be put under tight control. Industries such as steel, cement, flat glass and electrolytic aluminum will implement supply-side structural reform and eliminate excess capacity by means of marketization and legalization. 2. Energy Conservation To further optimize the energy structure, the authorities will…

Sep. 15th, 2022

China Pharmaceutical Regulatory Updates | August 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. Contents China NMPA Grants One Rx-to-OTC Switch China NMPA Publishes the 57th List of RLDs China NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol China NMPA to Adopt ICH E8 (R1) and E14 Guidelines CDE Seeks Public Comments on Pharmaceutical Guideline Drafts China NMPA Grants One Rx-to-OTC Switch On Aug. 26, NMPA granted OTC status to Omeprazole Enteric-coated Tablets, a widely used drug for gastrointestinal diseases. According to Menet Database, Omeprazole\’s sales value in China\’s retail market reached 1.068 billion yuan (circa 155 million USD) in 2020. China NMPA has approved 5,041 OTC drugs, including 1,111 chemical drugs, 3,921 traditional Chinese medicines, and…

Sep. 14th, 2022

FAQs on BE Study, Reference Listed Drug, and Quality & Therapeutic Equivalence Evaluation | China CDE

Notes: For frequently asked questions concerning technical issues, China Center for Drug Evaluation (CDE) releases answers on its website. This article is the translation of part of the Q&As, with slight modifications made according to the updated regulations. In case of any discrepancies, CDE\’s official announcements shall prevail. If you have enquiries about drug applications, please contact BaiPharm for professional help. Q&A Topics  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 of 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 This article covers topics 3, 4, and 5. For Q&As on the first two topics, please refer to the FAQs on Drug Registration Applications & Clinical Trials | China CDE. Stay tuned to us and we…

Sep. 09th, 2022

Chinese Pharmacopoeia: Understanding 42 Guidelines [English Version Available]

Chinese Pharmacopoeia is an official collection of drug standards, covering drug development, production, sale, utilization, supervision, and control in China. It is compiled by the Chinese Pharmacopoeia Commission. A new edition of Chinese Pharmacopoeia is regularly published every five years. The latest edition of Chinese Pharmacopoeia was released on July 2, 2020, and took effect on Dec. 30, 2020. It includes 5,911 monographs on 2,711 traditional Chinese medicines, 2,712 chemical drugs, 153 biologics, and 335 pharmaceutical excipients. Contents of Chinese Pharmacopoeia 2020 Volume Content Number Volume I Traditional Chinese medicine monographs 2,711 Volume II Chemical drug (including chemical APIs, also known as active pharmaceutical ingredients) monographs 2,712 Volume III Biologic product monographs 153 Volume IV General chapters General requirements for preparations 38 Testing methods and other requirements 281 Guidelines 42 Pharmaceutical excipients monographs 335 The Chinese Pharmacopoeia 2020 Edition also includes 361 general chapters, including 38 general requirements for preparations, 281 testing methods and other general chapters, and 42 guidelines. 42 Guidelines General Chapter No. Guideline…

Sep. 05th, 2022

Carbon Neutral: China to Build a System for Carbon Emission Calculation

China strives to build a unified and standardized system for carbon emission calculation. On August 19, 2022, China released a plan to accelerate the construction of a system to calculate carbon emissions. By 2023, China should preliminarily establish a unified and standardized calculation system with a clear division of responsibilities and coherent coordination among all relevant departments. By 2025, The calculation system will be further improved with enhanced statistical quality, so as to provide comprehensive, scientific, reliable data support for China’s endeavour to peak its emissions by 2030 and secure carbon neutrality by 2060, the plan said. Four Main Tasks are Deployed in the Plan The National Bureau of Statistics should formulate a unified calculation method at national and municipal levels and carry out calculations on annual carbon emissions; Ministry of Ecology and Environment, The State Administration for Market Supervision and industrial authorities should lead in the formulation and amendment of calculation methods and…

Aug. 30th, 2022

How to Get Drug Marketing Authorization Holder (MAH) Agency Services in China

In China, pharmaceutical companies or research institutes with drug registration certificates are drug marketing authorization holders (MAHs). According to the Drug Administration Law, marketing authorization holders should assume the responsibilities for drug safety, efficacy and quality controllability during the entire life cycle covering R&D, manufacturing, supply, and use. To better help international marketing authorization holders with regulatory compliance in China, BaiPharm publishes this article to answer the following questions: What are the obligations of drug marketing authorization holders? Should overseas marketing authorization holders appoint a Chinese agency? What are the marketing authorization holder agency\’s responsibilities? What agency services can BaiPharm offer to overseas marketing authorization holders? Obligations of Drug Marketing Authorization Holders  Marketing authorization holders shall be responsible for nonclinical research, clinical trial, manufacturing and sale, post-marketing research, as well as adverse drug reaction (ADR) monitoring, reporting and handling as per the Drug Administration Law. Overseas MAHs shall appoint a legal corporate entity in…

Aug. 29th, 2022

China Suspends UCB\’s Antiepileptic Drug \”Keppra\” from Import, Sale, and Use

On Aug. 24, China National Medical Products Administration (NMPA) suspended the import, sale, and use of UCB Pharma S.A.\’s Levetiracetam Concentrated Solution for Injection (Keppra), a drug for epilepsy treatment. In a recent remote inspection of UCB\’s manufacturing factory in Belgium, NMPA found that the labelled validity period of some batches of Levetiracetam was inconsistent with the one approved. NMPA concluded that the products did not comply with the pharmaceutical Good Manufacturing Practice (GMP). Official Notice In response to the suspension, it is reported that UCB has recalled all involved batches of the products. The company is taking corrective measures to restore its supply to the Chinese market as soon as possible. In 2020, UCB won the bidding to supply Levetiracetam Concentrated Solution for Injection in China\’s third round of national volume-based procurement (VBP). Though the product\’s one-year VBP procurement term ended, the suspension could influence some provinces that have…

Aug. 29th, 2022
  • 문의하기
  • +82-02-6245-1610
  • korea@reach24h.com

TSCA Inventory Search Tool