未分类 - REACH24H Consulting Group

Home
> 未分类

China Greenlights Online Sales of Prescription Drugs in Shenzhen

China officially permits Shenzhen to pilot the online sales of prescription drugs, according to the market-access-relaxing measures released by National Development and Reform Commission and the Ministry of Commerce on Jan. 26. Following the Hainan Free Trade Port, Shenzhen becomes the second place allowed to sell prescription drugs online. Before the pilot programs in Hainan and Shenzhen, no regulations in China have unequivocally allowed the online trade of prescription drugs. However, some provincial governments and third-party e-commerce platforms like Alibaba and JD.com have had a try amid the trend of internet-based diagnosis and treatment in recent years. The online sales of prescription drugs, as an unauthorized activity, has received continuous objections due to public concerns about drug abuse. Therefore, to ensure safety, the pilot measures for Shenzhen only allow prescription drugs to be sold to patients who have the corresponding prescriptions. The prescriptions should come from the Shenzhen Electronic Prescription…

Feb. 16th, 2022

Pesticide Regulation TALK | Global Pesticide Registration in 2022

Background In recent years, the global pesticide enterprises are facing various challenges due to the control of environmental protection and production costs. More and more enterprises begin to look for new opportunities in the international market to expand their market share. REACH24H has been deeply engaged in the global pesticide registration regulations for many years, committed to helping enterprises break the global import and export trade barriers, create value with compliance. With years of regulatory research and practical experience, REACH24H is launching the Pesticide Regulation TALK | Global Pesticide Registration in 2022 to share with the pesticide enterprises. The online courses will be divided into four sessions, each on the last Wednesday of February through May. Contents Webinar I：Experts Talk | China Pesticide Regulation and Registration Webinar II：Application and Development of (Q) SAR in Pesticide Regulation Webinar III： Biocide Compliance Strategy｜ Research of EU BPR and K-BPR Webinar Ⅳ：Interpretation of…

Jan. 29th, 2022

Pesticide Regulation TALK | Global Pesticide Registration in 2022

Background In recent years, the global pesticide enterprises are facing various challenges due to the control of environmental protection and production costs. More and more enterprises begin to look for new opportunities in the international market to expand their market share. REACH24H has been deeply engaged in the global pesticide registration regulations for many years, committed to helping enterprises break the global import and export trade barriers, create value with compliance. With years of regulatory research and practical experience, REACH24H is launching the Pesticide Regulation TALK | Global Pesticide Registration in 2022 to share with the pesticide enterprises. The online courses will be divided into five sessions, each on the last Wednesday of February through May. Contents Webinar I：Experts Talk | China Pesticide Regulation and Registration Webinar II：Application and Development of (Q) SAR in Pesticide Regulation Webinar III： Biocide Compliance Strategy｜ Research of EU BPR and K-BPR Webinar Ⅳ：Interpretation of…

Jan. 29th, 2022

Food and Food Supplements – Indian Market and FSSAI Regulatory Scenario

Background The Indian Dietary Supplement Market was valued at USD 3924.44 Million in FY2020 and is predicted to grow at a CAGR of 17.28% until FY2026, to reach USD 10,198.57 Million by FY2026 as of 17th May 2021. In FY2020, combination dietary supplements held the lion\’s share in the market since vitamin & mineral dietary supplements contain a variety of micronutrients, water-soluble & fat-soluble vitamins that help the body to function smoothly and improve mental health as well. Based on distribution channels, pharmacies & drug stores led the market with a share of 64.49% in FY2020 as the government licenses them to sell drugs and dietary supplements as prescribed by doctors or health professionals. Even after the intensity of the pandemic dropped, nutraceuticals continued to be preferred. The second wave has seen that the nutraceutical sector has built and will continue to grow its presence in the market. The current situation paints…

Jan. 19th, 2022

Food and Food Supplements – Indian Market and FSSAI Regulatory Scenario

Background The Indian Dietary Supplement Market was valued at USD 3924.44 Million in FY2020 and is predicted to grow at a CAGR of 17.28% until FY2026, to reach USD 10,198.57 Million by FY2026 as of 17th May 2021. In FY2020, combination dietary supplements held the lion\’s share in the market since vitamin & mineral dietary supplements contain a variety of micronutrients, water-soluble & fat-soluble vitamins that help the body to function smoothly and improve mental health as well. Based on distribution channels, pharmacies & drug stores led the market with a share of 64.49% in FY2020 as the government licenses them to sell drugs and dietary supplements as prescribed by doctors or health professionals. Even after the intensity of the pandemic dropped, nutraceuticals continued to be preferred. The second wave has seen that the nutraceutical sector has built and will continue to grow its presence in the market. The current situation paints…

Jan. 19th, 2022

China Cosmetic Compliance: Practical Guidance on Ingredient Submission Code Application

Background As per the Provisions for Management of Cosmetic Registration and Notification Dossiers that came into effect on May 1, 2021, when applying for registration or notification, cosmetic registrants or notifiers shall provide safety-related information of ingredients used in the product. Considering the complexity of the required documents, NMPA also gives a solution, which is ingredient submission code. With this code, the registrants or notifiers can directly associate ingredient safety information by filling in it to complete the registration and notification application, which could make the application more convenient and effective. On December 31, 2021, China NMPA launched the Cosmetic Ingredient Safety Information Submission Platform, which enables cosmetic ingredient manufacturers or their authorized companies to obtain an ingredient submission code after submitting ingredient safety-related information. Overseas companies can also log in the platform to apply for the code by themselves. In the future, NMPA will definitely promote the use of submission code. Cosmetic…

Jan. 13th, 2022

China Cosmetic Compliance: Practical Guidance on Ingredient Submission Code Application

Background As per the Provisions for Management of Cosmetic Registration and Notification Dossiers that came into effect on May 1, 2021, when applying for registration or notification, cosmetic registrants or notifiers shall provide safety-related information of ingredients used in the product. Considering the complexity of the required documents, NMPA also gives a solution, which is ingredient submission code. With this code, the registrants or notifiers can directly associate ingredient safety information by filling in it to complete the registration and notification application, which could make the application more convenient and effective. On December 31, 2021, China NMPA launched the Cosmetic Ingredient Safety Information Submission Platform, which enables cosmetic ingredient manufacturers or their authorized companies to obtain an ingredient submission code after submitting ingredient safety-related information. Overseas companies can also log in the platform to apply for the code by themselves. In the future, NMPA will definitely promote the use of submission code. Cosmetic…

Jan. 13th, 2022

FDA Withdraws Temporary Guidance for Hand Sanitizers

Companies may no longer manufacture under Temporary Guidance beyond December 31, 2021 The Temporary Emergency Use Authorization (EUA) on hand sanitizers was first authorized by the US FDA in March 2020 given the difficulties consumers and health care professionals experienced accessing alcohol-based hand sanitizers at the start of the COVID-19 pandemic. Hand sanitizers are regulated as an Over-the-Counter (OTC) drug in the US and must meet all of safety requirements outlined by the FDA. The temporary EUA relaxed some of the requirements to allow for other companies to support the need/demand for hand sanitizers. Hand Sanitizers manufactured under the US FDA’s Temporary EUA may no longer be manufactured/imported in the US after December 31, 2021. Distributors/Resellers may continue to sell/distribute products manufactured under the EUA until March 31, 2022. Retailers may continue to sell existing inventory until depleted or until the expiry date of the product, whichever occurs first. The…

Dec. 23rd, 2021

A Look Back at 2021 with ChemLinked: Cosmetics Regulation Updates

Background 2021 was a year of significant events and progress in the cosmetic industry in the Asia-Pacific region. China officially implemented the long-awaited new cosmetic regulation—Cosmetic Supervision and Administration Regulation (CSAR) and its supporting rules, marking the full implementation of its new cosmetic regulatory framework. Japan launched a new version of the overarching technical standards for quasi-drugs—Japanese Standards of Quasi-drug Ingredients (JSQI 2021). South Korea introduced the natural and organic cosmetic raw material certification mechanism. China Taiwan, ASEAN countries (Indonesia, Malaysia, Vietnam, Thailand), India and Australia have also undergone several regulatory updates. Global cosmetic stakeholders need to stay vigilant about the frequent regulatory changes, so as to effectively address compliance challenges and aim for great success while shouldering their social responsibilities. Therefore, ChemLinked has prepared this webinar to provide an overview of the revised and emerging cosmetic regulations in the Asia-Pacific region over the year and educate our clients on key regulatory points. *Notes:…

Dec. 21st, 2021

China Enacts Mandatory Standard for Body-use Antimicrobial Lotions(GB 384056-2020)

On December 1, 2021, China began to enact the national standard, “GB 38456-2020 Hygienic Requirements for Antibacterial and Bacteriostatic Lotion”. The standard clarifies the definition, requirements on raw materials, technical criteria, testing methods, labeling and instruction of these body-use disinfecting products, which would provide scientific foundations for the quality evaluation, correct product claim and consumer choice and promote the standardization process of China’s antimicrobial industry. Product Scope Antibacterial and bacteriostatic lotions are used for antibacterial/ bacteriostatic treatment on intact skin, vagina mucosa and oral mucosa, but excluding those applied on specific body parts such as feet, eyes, nails, axilla, scalp, hair, nasal mucosa, and anorectal area, etc. The most typical antibacterial and bacteriostatic lotions used in our daily life are mouthwash, hand sanitizer and feminine wash with an anti-microbial claim. Raw Materials and Banned Substances All raw materials used shall conform to the quality criteria specified in the Chinese Pharmacopoeia in force, as well as…

Dec. 17th, 2021

TSCA Inventory Search Tool