China’s “Carbon Peak & Carbon Neutrality” Goals: Challenges and Opportunities for Enterprises

Background In 2020, China proposed the goals \”to peak carbon dioxide emissions by 2030 and to achieve carbon neutrality by 2060\”. In order to cope with global climate change, China has actively formulated and implemented a series of strategies, regulations, policies, standards and actions to  \”put in place a \’1+N\’ policy framework for carbon peak and carbon neutrality\”.Achieving carbon peak and carbon neutrality is a broad and profound initiative to the country and the industry. The \”1+N\” policy prompts energy transformation, raises up low-carbon technologies and accelerates the formation of a green, low-carbon circular industrial system. This revolution leads to essential challenges and opportunities to enterprises in China. And enterprises should take actions to seize the opportunities and participate in the country\’s green transformation. Contents International Trend of \”Carbon Peak & Carbon Neutrality\” China\’s \”Carbon Peak & Carbon Neutrality\” Strategies Challenges and Opportunities for Enterprises Key Compliance Points Schedule Date…

Aug. 23rd, 2022

China\’s Quality and Therapeutic Equivalence Evaluations of Generic Drugs

Background Generic drugs account for more than 90% of the marketed drugs in China. In 2012, China initiated the equivalence evaluation plan to require that generics should be equivalent to originator drugs in quality and efficacy. In 2016, China started implementing equivalence evaluation requirements for chemical drugs\’ oral solid dosage forms. In 2020, the evaluations expanded to chemical injections.Quality and therapeutic equivalence evaluations push pharmaceutical companies to develop and produce generic drugs of higher quality. If the generics with high levels of quality and efficacy pass equivalence evaluations, they will be deemed clinical substitutes for originator drugs. With lower prices, the generics have more advantages than originator drugs in public medical institutions\’ volume-based procurements. Thus, generics grow to take higher market shares. This webinar aims to help pharmaceutical companies understand China\’s regulatory requirements for the quality and therapeutic equivalence evaluation, its market impacts, and the data on accepted and approved…

Aug. 19th, 2022

An Overview of Vietnam\’s Market on Food Additives and Key Regulations

Background Since Circular No. 24/2019/TT-BYT on management and use of food additive by the Ministry of Health of Vietnam, international standard such Codex General Standard for Food Additives (GSFA) has been adopted for numerous food additives segments including alcohol, sauces, dairy products, etc… While the middle class and consumptions within Vietnam has increased dramatically appealing foreign players to enter the market to furnish its demand. In this webinar, we will discover the macro elements of Vietnam as well as its potential or trends that may directly or indirectly impact the Vietnam food additive market as a whole. In addition, the key regulations changes and procedures for foreign players to enter the Vietnam market. Contents Part 1 Company introduction 1.1 About Incorp Vietnam (Cekindo) Part 2 About Vietnam 2.1 Vietnam: At a glance 2.2 Key growth metrics Part 3 Food additives overview 3.1 Regulations overview 3.2 Product registration procedures 3.3 Importing…

Aug. 16th, 2022

An Overview of Vietnam\’s Market on Food Additives and Key Regulations

Background Since Circular No. 24/2019/TT-BYT on management and use of food additive by the Ministry of Health of Vietnam, international standard such Codex General Standard for Food Additives (GSFA) has been adopted for numerous food additives segments including alcohol, sauces, dairy products, etc… While the middle class and consumptions within Vietnam has increased dramatically appealing foreign players to enter the market to furnish its demand.In this webinar, we will discover the macro elements of Vietnam as well as its potential or trends that may directly or indirectly impact the Vietnam food additive market as a whole. In addition, the key regulations changes and procedures for foreign players to enter the Vietnam market. Contents Part 1 Company introduction 1.1 About Incorp Vietnam (Cekindo) Part 2 About Vietnam 2.1 Vietnam: At a glance 2.2 Key growth metrics Part 3 Food additives overview 3.1 Regulations overview 3.2 Product registration procedures 3.3 Importing and…

Aug. 16th, 2022

Keeping Up with the Global Cosmetic Ingredient Updates in 2022

Background Ingredient quality directly affects cosmetics\’ quality. Being keenly aware of this fact, regulatory departments around the world have been placing ingredient safety at the core of cosmetics supervision. To ensure the marketed products are safe enough, they closely monitor the ingredient use in cosmetic industry, and provide regular updates to ingredient regulations. So far this year, a great number of ingredient-related regulatory changes have taken place globally. China launched consultation on the draft Safety and Technical Standard for Cosmetics 2022, which adjusts the list of restricted ingredients used in cosmetics and standardizes the application scope of some ingredients. ASEAN held the 35th ASEAN Cosmetic Scientific Body (ACSB) meeting, during which it approved new amendments to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive. China\’s Taiwan, South Korea, EU have also introduced several regulatory changes. To help cosmetic stakeholders stay vigilant to cope with these changes and further ensure the…

Aug. 12th, 2022

Infant Formula Regulation Difference Between EU and China

Background EU countries are China’s important traders of infant formula, supplying raw materials as well as finished products to China. In the past few years, China made strict policies on market entry permits, such as formula registration and manufacturer registration. Moreover, China is going to enforce the revised standards for infant formula early next year. These product standards become more consistent with the ones in the EU although they still have differences. As the birth rate of Chinese babies drop sharply but the relative standards and regulations became stricter, REACH24H suggests stakeholders review the situation in advance and consider the future business in China. Contents  Why analyze the difference main raw material supplier the distribution of registered EU infant formula manufacturers the distribution of registered EU infant formula Regulation similarity  Regulatory frame difference  Technical and compliance differences Q&A session Schedule Date Time (GMT+8) World Clock Language 2022-09-15 16:00 ~ 17:00…

Aug. 12th, 2022

Infant Formula Regulation Difference Between EU and China

Background EU countries are China’s important traders of infant formula, supplying raw materials as well as finished products to China. In the past few years, China made strict policies on market entry permits, such as formula registration and manufacturer registration. Moreover, China is going to enforce the revised standards for infant formula early next year. These product standards become more consistent with the ones in the EU although they still have differences. As the birth rate of Chinese babies drop sharply but the relative standards and regulations became stricter, REACH24H suggests stakeholders review the situation in advance and consider the future business in China. Contents  Why analyze the difference main raw material supplier the distribution of registered EU infant formula manufacturers the distribution of registered EU infant formula Regulation similarity  Regulatory frame difference  Technical and compliance differences Q&A session Schedule Date Time (GMT+8) World Clock Language 2022-09-15 16:00 ~ 17:00…

Aug. 12th, 2022

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
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