Turkey REACH: KKDIK Registration Progress and Strategy

Background The Turkish Authorities (MoEU) published the expected REACH-like regulation (KKDIK) in the official Gazette of the State on 23 June 2017. There is no requirement for tonnage classification registration in Turkish regulations. All enterprises exporting more than 1 ton/year need to complete registration before December 31, 2023. Registration in Turkey REACH is under going and very active. Then the main points of this webinar will introduce the current work of formal registration in Turkey REACH including the requirements and progress of formal registration, strategies and suggestions on how enterprises should prepare for registration and so on. Contents Review of the regulations for registration of KKDIK The progress and updates of KKDIK Strategies and suggestions for KKDIK Registration in several scenarios Notes on preparing for registration Schedule Date Time (GMT+8) World Clock Language May 18, 2022 10:00 ~ 11:00 Beijing: 10:00-11:00 Chinese May 18, 2022 21:00-22:00 London: 14:00-15:00 New York:…

Apr. 11th, 2022

CSAR Series: Decoding China’s New Cosmetic Labeling Regulation

Background Non-compliant cosmetic labeling is the primary reason for customs rejection in 2021, and the common reason for the failure of cosmetics registration/notification review and post-market inspection. Relevant enterprises may face administrative penalties such as corrections within a time limit, fines, etc., resulting in economic losses. On June 3, 2021, China NMPA issued the finalized Administrative Measures on Cosmetics Labeling, spelling out the requirements for the labeling and prohibited claims of cosmetics (including cosmetics provided to consumers in the form of trial, gift, exchange, etc.) under China\’s new cosmetic regulations. The Measures will be implemented on May 1, 2022. Compared with the previous labeling regulations, the Measures has stricter requirements in terms of labeling definition, consistency with registration/notification documents, Chinese labels, product naming, guiding words, etc. Labels of many registered/notified cosmetic products need to be redesigned and updated. During the webinar, Demi Ding from REACH24H will explain the required contents and noteworthy points in labeling imported cosmetics, analyze common non-compliance…

Apr. 08th, 2022

China Pharmaceutical Regulatory Updates | March 2022

China NMPA Releases the 52nd List of RLDs On March 11, China NMPA released the 52nd List of Reference Listed Drugs (RLDs). The list covers 52 drugs, including Abbott\’s Complex Packing Estradiol Tablets/Estradiol and Dydrogesterone Tablets, as well as Merck\’s Bisoprolol Fumarate and Amlodipine Besylate Tablets.1 CDE Consults on Procedures for Adjusting the RLD List On March 11, CDE published the draft of Procedures for Adjusting the Released Reference Listed Drugs for public comments. Up to date, there are 4,849 RLDs in the Catalog of Reference Listed Drugs. The RLDs are selected as reference products to which new generic drugs are compared to demonstrate bioequivalence. However, a RLD may be delisted for any one of the problems: The RLD has been disqualified from marketing authorization or withdrawn from the market due to risks in safety, efficacy, or quality control. The RLD does not comply with the requirements of the current Chinese Pharmacopoeia or the technical review. Its…

Apr. 08th, 2022

Regulatory Analysis of European and American Food Contact Material Legislations

Background Food contact materials (FCM) include food containers, packaging, machinery or kitchenware. The material types can be plastics, paper and board, metal, glass, ceramics etc. Additives and processing aids can also be added to the FCM in order to achieve the purpose of use. FCM can contain chemicals that could migrate to food that we consume in our daily life. In order to reduce the exposure to potentially hazardous substances and protect human health, safety of FCM has to be assessed thoroughly. Therefore, more and more attention has been paid to the management of FCM safety recently. The regulatory systems in the EU and the US have already been very developed and are well accepted internationally. In fact, many countries and regions has established their own management systems by citing the European or American FCM regulations directly. In this webinar, we are going to introduce the European and the American…

Apr. 06th, 2022

Update on ASEAN Harmonization of Health Supplements Requirements – Impact & Tips

Background Since 2004, the ASEAN Member States, with the support from the ASEAN Consultative Committee for Standards and Quality Traditional Medicines and Health Supplements Product Working Group (ACCSQ TMHS PWG) has been working on the harmonization of Health Supplement standards and requirement. The development of the harmonized technical standards and requirements has been completed and the ASEAN Senior Economic Official Meeting (SEOM) has given approval for the signing of the ASEAN Health Supplement Agreement by the 3rd Quarter of 2022. The ASEAN Agreement on Health Supplement is a legally binding document. By signing the agreement, Member States will be committed to changing their laws/regulations to meet the harmonized technical requirements. In this webinar, Ms Poon Wai Mun, Regulatory Affairs Consultant from Wong SJ Asia Pte Ltd, will bring an overview and interpretation of the ASEAN Health Supplements Agreement. The impact of the Agreement signing and tips for stakeholders to cope…

Mar. 28th, 2022

Generic Drug Application Procedures in China

Background China has become a powerhouse that manufactures and imports generic drugs. These years, the country\’s Center for Drug Evaluation (CDE) has approved substantial abbreviated new drug applications (ANDA) for generics. In 2020, CDE completed reviewing 1,700 ANDAs, accounting for 19.75% of all the 8,606 applications that entailed technical review. In China, the competition is spiraling up for generics as the drug regulators mandate consistency evaluation for generic products and slash prices through negotiation for volume-based procurement (VBP). Nevertheless, the Chinese market still has huge potential for generic drug products, especially for generics that overcome technical barriers. In this webinar, we will introduce how to apply for generic drug registration in China and answer the following questions: What are the corresponding requirements for registering generics under each different classification? What are the specific requirements in China for Chemistry, Manufacturing and Controls (CMC) changes to approved ANDAs？ Will overseas clinical/bioequivalence (BE)…

Mar. 25th, 2022

All You Need to Know about Cosmetic Laws and Regulations in South Korea

Background South Korea has the most unique and wholesome cosmetic regulation scheme globally, which guides product safety and encourages product innovation at the same time. Fully understanding Korea\’s cosmetic regulation definitely can help enterprises in developing their products no matter whether you are targeting the Korean market or not. However, the complex regulations and the language barrier stop many overseas companies from learning the compliance requirements and entering the Korean market. This webinar will give you an overarching understanding of the cosmetic laws and regulations in South Korea, including the product standard, ingredient requirements, and the import procedure, etc. Contents Legislation and Regulation Introduction Ingredient Standard Functional Cosmetic Natural and Organic Cosmetic Custom Cosmetic Import Procedure Limitation Q&A *The final outline may be subjected to subtle revision. Schedule Date Time (GMT+8) World Clock Language Speaker 2022-04-21 21:30 ~ 22:30 London: 13:30-14:30 New York: 08:30-09:30 English Lorraine T.S. Li 2022-04-22 15:00…

Mar. 24th, 2022

A Full Picture of Chinese Functional Food/Health Food Market

Background In 2022, the Chinese functional food market will exceed 600 billion yuan. Chinese consumers’ health awareness improved significantly during the pandemic, contributing to higher health spending and more attention to functional food. In the meantime, more brands have emerged in this market. Many companies from other sub-sectors, such as pharmaceutical companies and milk powder companies, have also begun to cross the border to enter the functional food sector. Together, they develop and launch many innovative new products, such as protein cookies, hyaluronic acid gummy bears, etc. These changes boost the whole market unprecedentedly. Though the Chinese functional food market has a positive future, it remains chaotic and complicated. What are the differences between functional food and health food? How is the competition in the market? Are there any dominant brands? What kinds of products do consumers prefer? Do imported products have competitive advantages over domestic products? The webinar aims…

Mar. 23rd, 2022

How to Increase the Efficiency of Your Food Compliance Management?

Background Are you dealing with inefficient compliance reviews of food ingredients? Not sure whether the existing labels meet China food regulations? Are you confused about the food ingredients prohibited or restricted in China? Food ingredient or label incompliance has always been the major reason for food rejection by Chinese customs according to our daily monitoring. It is time-consuming and always takes a lot of efforts for enterprises to search for relevant legal basis to confirm the compliance of their products. In this case, Food Combox, the food compliance system newly developed by ChemLinked, can help you make compliance audit and label production faster, easier, and more enjoyable with its’ data intelligence. This webinar is organized to help members make better use of ChemLinked COMBOX. To have your questions well addressed during the webinar, please send them to vicki@chemlinked.com in advance. Contents Non-compliance status of food ingredients and labeling in China…

Mar. 23rd, 2022

K-BPR: New Requirement for the Packaging and Advertising of Household Chemical Products and Biocidal Products

On February 10, 2022, the South Korean Ministry of Environment (MoE) issued the MoE Ordinance No.972 to announce amendments to the Enforcement Rules of the Act on Safety Management of Household Chemical Products and Biocides (a.k.a. K-BPR Enforcement Rules). A new requirement was added in the revised K-BPR Enforcement Rules, stipulating that the corresponding report/approval number of the household chemical products or the approval number of the biocidal products is also required for the packaging or advertising to verify the compliance with the safety standards. This new requirement will take into effect on August 11, 2022. Consumers can use the report number or approval number to search on the MoE official website to check relevant information, including contact information of the manufacturer/importer, ingredients and contents of the product, hazard information, permitted uses, etc. The MoE expects to increase information transparency and reduce potential risks caused by such products by providing the information mentioned above….

Mar. 22nd, 2022
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