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How Brands Promote Cosmetic Efficacy to Consumers in China, South Korea and Japan?

Background Cosmetics consumers eagerly expect visible proof of product efficacy which will help them understand product benefits. According to different sources, more than 90% of Japanese women expect to get information on skincare product efficacy, while function & ingredient is the No. 1 factor that 54% of Chinese consumers consider when choosing a skincare product. Competition is intense and challenging, and companies are highlighting many new creative ways and specific directions/images to promote their products: from scientist demonstrations, and open sources to press releases, ingredient storytelling or emotional activation, without mentioning the texture illustration. Asia Cosme Lab, the French consulting agency dedicated to the Asian cosmetics market for more than 20 years, will highlight in a comprehensive way how key Asian brands and new players are communicating to the consumers their reasons for believe from scientific drivers to emotional efficacy insights. The webinar will screen via social networks, brand websites, influencers’ voices, retail…

Sep. 13th, 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

Asia Pacific: Decoding Probiotic Regulations for Food & Health Supplements

Background Academics and consumers now recognize gut microbes\’ important role in human health. As the demand for probiotic and prebiotic products grows, more and more probiotic Foods and Health Supplements are being introduced into the ASEAN region. In response, regulatory agencies are developing regulations and guidelines to govern the sales and marketing of probiotic supplements and functional foods. Wai Mun offers a guide to the current status and application of regulations across ASEAN demonstrating the challenges faced by diverse regulatory systems in key countries. Her insights will help manufacturers avoid common pitfalls and maximize opportunities for success. China has become the second largest probiotic market in the world. The fast-growing probiotic industry has attracted many newcomers. However, there are still some improvements that need to be done to China\’s probiotic laws and regulations. China has also issued a series of relevant laws and regulations to promote and regulate the development…

Aug. 30th, 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

China’s “Carbon Peak & Carbon Neutrality” Goals: Influences for Enterprises in Food and Beverage Industry

Background In order to cope with global climate change, China proposed the goals of \”to peak carbon dioxide emissions by 2030 and to achieve carbon neutrality by 2060\” in 2020. So far 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.\” \”1\” refers to the programmatic documents for the realization of the “Carbon Peak & Carbon Neutrality” goals, while \”N\” refers to a series of guiding policies and programs in different fields.Achieving carbon peak and carbon neutrality is a broad and profound initiative for the country and the industry, which will affect many enterprises, especially food and beverage enterprises with strong links with agriculture and manufacturing, because this industry has caused a large proportion of greenhouse gas emissions. Therefore, enterprises in the food and beverage industry are highly recommended to…

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

Decoding EU Food Regulation

Background The webinar will explain the basics of EU law, offering the tool to navigate the main regulations and find relevant information. Key points related to food safety, food labeling and food contact material regulations will be highlighted. The webinar will be an excellent opportunity for exporters to the EU to get a first exposure to local rules, understand how to effectively approach the market and avoid major roadblocks. The webinar is suitable for everybody who is approaching EU legislation (e.g., regulatory managers, young professionals and food lawyers, export managers). The speaker will answer Q&A, offering his ten years top level experience in the field. Contents EU food law: understand the structure and how different layers of legislation interact (EU law vs. national law) Where to find information and legislation The \”General Food Law\” (Reg. CE 178/2002): definition of unsafe food, the precautionary principle, traceability obligations, food recalls and withdrawals…

Aug. 26th, 2022

Overview of the Canadian Regulatory Framework for Cosmetics

Background The cosmetics market in Canada generated increasing revenues over the past years and is expected to grow to roughly 1.8 billion U.S. dollars by 2026. All cosmetics sold in Canada must be safe to use and must not pose any health risk. According to the Food and Drugs Act and the Cosmetic Regulations, cosmetic manufacturer and importer must provide a list of the product\’s ingredients, and notify Health Canada that they are selling the product. Failure to notify may result in a product being denied entry into Canada or removed from sale.In addition, all cosmetics must follow the requirements outlined in the Consumer Packaging and Labelling Act and its associated regulations. Any chemicals found in cosmetics may be subject to the Canadian Environmental Protection Act. In this webinar, Health Canada, the cosmetic competent authority, will explain the cosmetic regulatory framework, compliance requirements, ingredient use requirements, future regulatory plan, etc. and finally provide references and guidance for the…

Aug. 23rd, 2022

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