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

A Look back at 2021 with ChemLinked Food Regulation Updates

Background The year 2021 witnessed many significant regulatory updates in the Asia-Pacific region. In China, several significant food standards were released, such as the new GB standard for infant formula milk powder. It is noteworthy that GACC released two important regulations regarding imported food as well. South Korea has many critical regulatory revisions in 2021, regarding labeling requirements, food raw material inventory and the HACCP accreditation for overseas Kimchi factories. Japan also adopted new food additives and labeling requirements in the past year. Global food stakeholders need to stay vigilant to cope with frequent regulatory changes, 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 revised and emerging food regulations in the Asia-Pacific region over the year and help our clients analyze key regulatory points. Notes: The webinar is free for all ChemLinked members,…

Dec. 16th, 2021

Demystifying the Food Regulation and Import Requirements in Vietnam

Background The expansion of Vietnam\’s middle class has led to surging demand for new food products from the west as well as from the rest of Asia. In 2020, total sales from food and beverage items was USD $43,000,000, up 3.8% year on year. In addition, the food and beverage industry contributed around 15.8% to the country\’s GDP. The objective of this webinar is to provide an overview, process and documents regarding the food product registration in Vietnam. During the webinar Joseph Sang Nguyen and Michael Claro from Cekindo will go into detail about the regulations, the import regulations, the required documents and detailed steps in registering food products in Vietnam. Contents I. Background on the F

Dec. 16th, 2021

Introduction to New Chemical Substance Notification in the Philippines

Background Republic Act 6969 (R.A. 6969), known as the “Toxic Substances and Hazardous and Nuclear Waste Control Act of 1990”, is the key legislation on the management of chemical substances and mixtures in the Philippines published by the Department of Environment and Natural Resources (DENR) in 1990. It is stipulated that new chemical substances should obtain a corresponding compliance certificate before the first manufacture/importation. This seminar will mainly focus on the scope of notification, notification type, the requirements of different kinds of notifications and practical guidance of the OPMS system. Contents Background Introduction New Chemical Notification OPMS System Schedule Date Time (GMT 8) World Clock Language Speaker 2021-12-21 21:00 ~ 22:00 London: 13:00-14:00 New York: 08:00-9:00 English Rose Hong Speakers Sophie Zheng Senior Technical Specialist Ms. Sophie Zheng is mainly responsible for the declaration technology of new chemical substances in China and the registration of chemical regulations in the Philippines….

Dec. 08th, 2021

Decoding the Regulations of Quasi-drugs in Japan

Background According to Japan’s Pharmaceuticals and Medical Devices Act (the “Act”), cosmetics are classified into two categories: cosmetics and quasi-drugs. Quasi-drugs are a product category unique to Japan, which falls in between pharmaceuticals and cosmetics. They contain a certain concentration of active ingredients approved by the Ministry of Health, Labour and Welfare and have higher efficacy. Common examples include deodorants, depilatories, hair dyes, hair perms, and medicated cosmetics (whitening, anti-acne, anti-aging products, etc.). In recent years, the Japanese quasi-drug market has been continuously expanding, driven by increased environmental pollution and rising awareness for oral and personal hygiene. Foreign enterprises accordingly show interest in the lucrative market. However, many of them have difficulty accessing to the market due to Japan’s unique and complicated administrative rules and language barriers. This webinar aims to shed light on the regulatory requirements of quasi-drugs in Japan. In the webinar, Ms. Rose Hong, the regulatory analyst from ChemLinked, will introduce the…

Nov. 30th, 2021

New Market Entry Pathways of Medical Products: Special Medical Zones in China

In China, many patients resort to unconventional means of receiving treatment for their diseases, like going abroad or relying on surrogate shoppers. According to a New York Times article, in 2017, approximately 600,000 Chinese patients travel abroad to receive medical treatment.1 Although China\’s review and approval process of drugs has been significantly accelerated after years of reform, certain aspects of China\’s medical industry still prevent some foreign drugs from reaching the market. For instance, the government\’s regulation on drug\’s pricing, the Chinese market\’s complexity due to the diverse population and vast territory, and the uncertainty of competition from similar products all are able to deter small to middle-sized pharmaceutical companies from investing capitals and conducting clinical trials in China. Things have changed a lot in recent years as the Chinese government actively engages in promoting the development of pharmaceutical industry and subsequently proposed certain policies that could potentially ameliorate this common…

Nov. 19th, 2021

China to Implement Good Pharmacovigilance Practices

China National Medical Products Administration (NMPA) officially issued the Good Pharmacovigilance Practices (GVP) on May 13, 2021, after releasing the consultation draft in December last year. GVP, made for regulating and guiding pharmacovigilance activities, is set to come into enforcement on Dec. 1, 2021. Who does GVP address? The Chinese GVP applies to Marketing Authorization Holders (MAHs)\’s pharmacovigilance activities about medicinal products and drug registration applicants with authorization to carry out clinical trials. Pharmacovigilance activities are defined as activities to monitor, identify, evaluate and control adverse drug reactions (ADRs) or other negative reactions related to medication. As NMPA announced GVP, the authority asked MAHs and drug registration applicants to gear up for fulfilling the GVP requirements, saying they should establish pharmacovigilance systems to organize relevant activities in line with laws and regulations. NMPA also noted that MAHs should register at China National ADR Monitoring System within 60 days from GVP\’s release date. Covering Every Stage of Drug Life Cycle The GVP has comprehensive contents,…

Nov. 19th, 2021

Expedited Programs for Drug Registration in China

According to China\’s Administrative Measures for Drug Registration enacted since July 1, 2020, the National Medical Products Administration (NMPA) shall launch expedited programs for drug registration to support clinical-value-oriented innovation in drugs. China currently follows four programs for accelerating the review and approval of new drug applications (NDA) that meet the corresponding criteria. breakthrough therapy designation (BTD); conditional approval (CA); priority review (PR); special approval (SA). If an NDA enter any of the above programs, NMPA and its professional institutions will offer policy and technology support to the applicant. The support includes necessary technical guidance, communication with the applicant, preferential allocation of resources, and shortening the review time. 1. Regulatory Updates on Drug Review and Approval in China To take the lead in the ever-changing Chinese market, international pharmaceutical companies need to keep abreast of the regulatory updates of marketing authorization procedures: Laws, Regulations and Policies Involving Requirements for Drug Review and Approval in…

Nov. 19th, 2021

China DMF Filing, Review

China\’s drug review

Nov. 19th, 2021

Southeast Asia Focus: How to Export Cosmetics to Cambodia, Laos and Myanmar

Background With a burgeoning young population and a growing middle class, Cambodia, Laos, and Myanmar market is viewed as the new frontier for overseas companies in the beauty and cosmetics industry. Revenue in the beauty and personal care market of Cambodia, Laos, and Myanmar amounts to 3.4 billion USD in 2021. The large population of young people in these 3 countries is deeply influenced by the global beauty trends and eager to embrace a modern lifestyle. They value the importance of skin and facial care, combined with the increasing purchasing power, their demand for cosmetics and beauty products in particular have excellent potential. The relative difficulties of securing quality local manufacturing present importers with excellent opportunities. Cosmetic imports can quickly become household names as the market develops. By arriving early in the marketplace, brands can shape preferences for their cosmetics among the target consumers. To that end, leading Southeast Asian law firm Tilleke

Nov. 19th, 2021
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