China CFDI 2021 Drug Inspection Overview

On June 26, 2022, China Center for Food and Drug Inspections (CFDI), a public institution under National Medical Products Administration (NMPA), issued the 2021 Work Report on Drug Inspections. The Report says that in 2021, CFDI completed 1,368 drug inspections, including 1,214 drug registration inspections, 101 drug supervision inspections, 6 overseas inspections, and 47 license inspections. Contents 1. Drug Registration Inspections 2. Drug Supervision Inspections 3. Overseas Inspections 4. License Inspections   1. Drug Registration Inspections 1.1 Definition Drug registration inspections verify the authenticity and consistency of the application materials, the commercial production condition, the compliance of R&D and manufacturing processes, and data integrity, etc. 1.2 Data In 2021, CFDI completed 1,214 drug registration inspections, including 1,066 inspections for clinical trial applications and marketing authorization applications; 148 inspections for the generic drugs\’ quality and therapeutic equivalence evaluations. 10 inspections reported failure results. 1.3 Problems Problems found in pharmacology and toxicology study inspections mainly include…

Jun. 30th, 2022

China Kicks off the 7th Round of Volume-based Procurement (VBP) of Drugs

On June 20, China National Joint Drug Procurement Office announced the start of the 7th round of volume-based procurement (VBP), covering 59 drugs with different active pharmaceutical ingredients. Companies qualified to supply the drugs are required to submit tenders on July 12. Procurement Volume, Term, and Price Limit The office also released each drug\’s total procurement volume, the percentage of procurement volume, and the price limit. For most chemical drugs, the procurement rules are as follows: Number of bid winners Procurement Volume of the 1st Year / the Total Agreed Procurement Volume * 100% Procurement Term 1 50% 1 year 2 60% 1 year 3 70% 2 years ≥ 4 80% 3 years For example, Afatinib Tablets (30mg)\’s tender price limit is required to be no higher than 112.3267 yuan. The drug\’s total procurement volume of the first year in the procurement term is 596,327 tablets. If there is only one…

Jun. 27th, 2022

China Revises Requirements on Greenhouse Gas Emission Reporting

On June 8, 2022, China’s Ministry of Ecology and Environment (MEE) issued the Notice on the Adjustment of the Key Tasks Related to the Management of Corporate Greenhouse Gas Emission Report in 2022 (hereinafter referred to as the Notice). Experts of REACH24H Consulting Group offered a detailed interpretation of the major amendments to facilitate relevant companies on carbon emission compliance. Extending the deadline for the verification of carbon emission of key emitting entities in the power generation industry in 2021 It was originally scheduled to complete the verification of the 2021 annual emission report of key emitting entities in the power generation industry and publish the list of 2022 key emitting entities before June 30, 2022. Considering the impact of Covid, there will be an inevitable delay in completing these tasks, as expected until the end of September 2022. Adjusting the value of carbon emission parameter of key emitting entities in the…

Jun. 21st, 2022

Carbon Neutrality Solutions

Overview According to the State of the Global Climate 2021 released by the World Meteorological Organization, human activities have increased the concentration of greenhouse gases in the atmosphere, causing the increase of global average surface temperature in 2021 by 1.11±0.13°C higher than before industrialization. As a result, over 6000 climate disasters occurred worldwide from 2000 to 2019, which increases by 83% compared with the previous 20 years. To jointly tackle global climate change, more than 130 countries proposed carbon neutrality goals. In 2020, China committed to \”peak carbon dioxide emissions before 2030 and achieve carbon neutrality before 2060.\” Under the pressure of global climate issues, China\’s “Dual Carbon” Goals and corresponding policies, green, low-carbon and sustainable development become a hot spot and a future trend in current economic and social development, and will be an indispensable part of future corporate compliance.   Current Global Supervision Policies and Laws China has…

Jun. 21st, 2022

China Consults on GMP for Pharmaceutical Packaging Materials

On June 2, China National Medical Products Administration (NMPA) released the draft of Good Manufacturing Practice of Pharmaceutical Packaging Materials (hereafter referred to as Packaging GMP) for public comments. The Packaging GMP specifies basic requirements for the manufacturing management and quality control of pharmaceutical packaging materials.   Contents 1. Application Scope of Packaging GMP 2. Contents of Packaging GMP 3. Packaging GMP Requirements 4. GMP for Pharma Industry   1. Application Scope of Packaging GMP Pharmaceutical packaging materials refer to Packaging materials and containers that have direct contact with pharmaceuticals; Functional secondary packaging materials, surface printing materials, components, and drug delivery devices & systems. The Packaging GMP applies to the overall manufacturing process of pharmaceutical packaging materials, including all the critical factors that affect the packaging materials\’ quality, and all the organized and planned activities to ensure the packaging materials accord with the intended uses.   2. Contents of Packaging GMP GMP for Pharmaceutical Packaging Materials (Consultation Draft)…

Jun. 14th, 2022

Japan Stipulates New Rules for SDS and Labelling

In addition to the addition of substances for mandatory GHS-related obligations under ISHL, the MHLW amended the Ordinance on Industrial Safety and Health to introduce new requirements for SDS and labeling.   On May 31, 2022, Japan’s Minister of Health, Labour, and Welfare (MHLW) published the amendments to Ordinance on Industrial Safety and Health (hereafter referred to as the Ordinance), which stipulated new rules about the SDS delivery methods, SDS elements, labeling requirements, etc. Japan GHS is implemented under three laws, including the Industrial Safety and Health Act (ISHL), the Pollutant Release and Transfer Register (PRTR) Law and the Poisonous and Deleterious Substances Control Act (PDSCL). According to the ambitious plan outlined in the final report of the Seminar on the Management of Chemical Substances in the Workplace, the MHLW is making progress to expand the number of hazardous chemical substances subject to mandatory SDSs and labels under ISHL. 234 substances…

Jun. 13th, 2022

China to Renew Medical Sodium Hyaluronate\’s Administrative Classifications

As more sodium hyaluronate products emerge on the market, China is going to update its regulations to better guide the registration and supervision of the products.   On May 20, China National Medical Products Administration (NMPA) released the revised draft of the Announcement on the Administrative Classifications of Sodium Hyaluronate Products for Medical Use (hereafter referred to as the draft and the Announcement, respectively) for public comments. The draft renews the classification system of medical sodium hyaluronate products according to their intended uses and mechanisms of action. RELATED: Interpreting Aesthetic Medicines: Thermage, Hyaluronic Acid and Collagen   Current Classifications of Medical Sodium Hyaluronate The current classifications are based on the 2009 version of the Announcement. Medical sodium hyaluronate products are generally classified into two categories: administered as drugs and as medical devices. Medical Sodium Hyaluronate Classification Products that have clear pharmacological effects, e.g., treating arthritis, dry eyes, skin ulcer, etc. Drug Adjuvant products in eye…

May. 30th, 2022

China to Renew Medical Sodium Hyaluronate\’s Administrative Classifications

On May 20, China National Medical Products Administration (NMPA) released the revised draft of the Announcement on the Administrative Classifications of Sodium Hyaluronate Products for Medical Use (hereafter referred to as the draft and the Announcement, respectively) for public comments. The draft renews the classification system of medical sodium hyaluronate products according to their intended uses and mechanisms of action.1 RELATED: Interpreting Aesthetic Medicines: Thermage, Hyaluronic Acid and Collagen Current Classifications of Medical Sodium Hyaluronate The current classifications are based on the 2009 version of the Announcement. Medical sodium hyaluronate products are generally classified into two categories: administered as drugs and as medical devices.2 Medical Sodium Hyaluronate Classification Products that have clear pharmacological effects, e.g., treating arthritis, dry eyes, skin ulcer, etc. Drug Adjuvant products in eye surgery; Anti-adhesion products in surgery; Tissue filler and tissue volume-augmenting products, etc. Medical Device Classifications for Consultation If following the current classification rules, some sodium hyaluronate products are…

May. 30th, 2022

China Encourages Innovative Drug R&D in Draft of Regulations for Implementing DAL, 2022

On May 9, China National Medical Products Administration (NMPA) released the draft of the revised Regulations for Implementation of the Drug Administration Law (hereafter referred to as the Regulations) for public comment. The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Compared to the 2016 revised version, the draft of the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019. The new contents involve a marketing authorization holder system, patent protection, and pharmacovigilance, whose regulations just came out in the past few years. (Pharmaceutical Application Services) RELATED: China\’s Marketing Authorization Holder (MAH) System; China\’s Drug Patent Linkage System; China\’s Good Pharmacovigilance Practices. Regulation Contents Contents of the Regulations for Implementation of the Drug Administration Law 2016 Revised Version1  Revised Draft of the 2022 Version for   Consultation2 Ÿ   Chapter I: General Provisions Ÿ   Chapter II: Administration of…

May. 20th, 2022

Generic Drug Application (ANDA) in China

Generic drugs comprise a significant part of China\’s pharmaceutical market. In 2020, 63% of marketed drugs in China were generics. The Chinese generic drug market size reached 970.7 billion yuan (143.85 billion USD) in 2019 and fell to 808.7 billion yuan1 (circa 119.84 billion USD) in 2020 due to the economic slowdown brought by the COVID-19 pandemic. However, China\’s generic drug market is expected to grow. One reason is that generics usually have lower prices than patented originator drugs, so generics have advantages in volume-based procurement where the price competition is fierce. Another reason is that generics\’ quality has improved remarkably since 2015 as China mandates that generics should be equivalent to originator drug/reference listed drug in quality and therapeutic effects. Furthermore, China encourages the development of clinically-needed and high-quality generics. In the drug patent linkage system, China awards the first generic to successfully challenge the relevant patent drug with 12-month market…

May. 19th, 2022
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