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

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

CRAC-HCF 2021： Embracing China\’s Pharma Market With Regulatory Compliance and Industry Insights

China\’s Drug Regulation and Pharmaceutical Market Conference, a sub-event of CRAC-HCF 2021 (Chemical Regulatory Annual Conference and Asian Helsinki Chemicals Forum), concluded on Nov. 12.Five experts from drug regulation authorities, pharmaceutical companies, and consulting firms decoded drug regulations and analyzed industry dynamics for international pharma companies to develop businesses in the Chinese market. CRAC-HCF 2021 Virtual Session China\’s Pharmaceutical Regulation and Market Overview Watch the Recording Topic Speaker Interpretation of Chinese Pharmacopoeia 2020 Edition Ms. Qiaofeng Tao, Vice President of Zhejiang Institute for Food and Drug Control China Market Entry Strategy for Overseas Pharmaceuticals Mr. Feng Zhou, Haisco Pharmaceutical Group Decoding China\’s Good Pharmacovigilance Practices Mr. Daniel Yu, Deputy PV Director of Zhejiang Taimei Medical Technology Co., Ltd Interpretation of China\’s Marketing Authorization Holder (MAH) System Ms. Manlu Xia, Industry Expert Focused Areas and Targets of Innovative Drug Research in China Mr. Liang Hong, General Manager of Ruiou BaiPharm Service Co., Ltd. Notes:…

Nov. 17th, 2021

Japan Revises the Ingredient Standards for Beverage

On June 29, 2021, Japan MHLW unveiled an amendment to “Standards and criteria for food and food additives, etc.” According to the amendment, the ingredient standards of mineral water (The Japanese Food Sanitation Law classifies it in the category of beverage) were revised. Notably, in Japan the \”mineral water\” includes products sterilized and unsterilized, and each category has its own standards. The revisions for the two categories are as the following: mineral water (unsterilized) Substance Current standard Previous standard Hexavalent chromium ＜0.02mg/L ＜0.05mg/L mineral water (sterilized) Substance Current standard Previous standard Hexavalent chromium ＜0.02mg/L ＜0.05mg/L Chloroacetic acid ＜0.02mg/L / Dichloroacetic acid ＜0.03mg/L / Trichloroacetic acid ＜0.03mg/L / Bis(2-ethylhexyl) phthalate ＜0.07mg/L / The amendment became effective upon its publication on June 29 with a six-month grace period. When processing, using, cooking, storing and selling the domestically produced and imported beverage within this six-month, the technical specification of Hexavalent chromium can refer to both previous and new standard, but that of Chloroacetic acid, Dichloroacetic acid,…

Jul. 20th, 2021

China Implemented New Fertilizer Marking Standard Starting from May 1

From May 1, 2021, China began to carry out a new national standard of fertilizer markings “GB 178382-2021 Fertilizer Marking—Presentation and declaration”. The mandatory standard applies to both homemade and imported fertilizers circulated in China, playing an effective role in protecting farmer’s interests and promoting legitimate businesses. Fertilizer marking is the illustration of product characteristics and quality commitment made by its producers and mainly consists of 3 parts: mandatory contents to be labeled on marking, rules and specification, and prohibited contents. The mandatory content includes 8 items and the key points are summarized as follows:

May. 17th, 2021

Decoding India’s New Cosmetics Rules 2020

Background The Cosmetic Rules 2020 was published in GSR 763 (e) by the India Ministry of Health and Family Welfare and enforced from December 15th, 2020. The new rules have streamlined, clarified the regulatory requirements and standards on the import, manufacture, and distribution of cosmetics in India. The new rules enhance accountability for importers and manufacturers with respect to the quality of their cosmetic products. The digitalization of the regulatory process going forward is also bound to increase efficiencies and make the application process smooth and less time-consuming to the importers and manufacturers. To help enterprises better cope with the Cosmetic Rules 2020, ChemLinked invited Ms. Rucha Kelkar, the founder of Praha Regulatory Consultants, to detail the key changes brought by the new rules, the regulatory requirements of imported cosmetics, and advice on regulatory compliance. Contents Cosmetic market in India Introduction to the Cosmetics Rules 2020 Comparisons between the old and new rules…

Apr. 22nd, 2021

영국 화학물질 규제 대응 서비스

영국 브렉시트 연혁 과도기 정책 2020년 12월 31일까지, 영국은 비록 EU 회원국이 아니지만 시장 진출 조건은 불변, 즉  과도기 정책 과도기간 내 EU-REACH는 여전히 영국에 적용됨;  영국은 유럽연합이 부여한 모든 등록, 승인과 분류 (REACH) 인정;  등록절차 불변, 영국의 회사는 여전히 유럽화학물질청 (ECHA)에 EU-REACH 등록 제출; 영국 보건안전청(HSE)은 ‘주무당국‘의 EU-REACH 관련 평가업무 불가;  영국 기업은 여전히 유럽연합 기업과 동등한 권리 보유 및 그 사건은 기타 유럽연합 회원 ‘당국‘에서 접수 및 처리함 UK-REACH 개요 만약 2020년 12월 31일까지 영국과 유럽연합 합의 미달성 시 2021.01.01부터 영국은 독자적인 UK REACH를 실시할 가능성이 아주 큼. UK REACH의 전체 틀, 등록절차와 요구는 현재 유럽연합 REACH （https://www.reach24h.com/chemical/serviceitem/e u-and-north-america/eu-reach.html와 대부분 일치.)  화학물질의 등록, 평가, 위임과 제한. 영국 경내에서 1톤/년 이상 화학물질을 생산하거나 수입하는 모든 기업은 해당 생산 또는 수입 화학물질에 대해 등록해야 함.  온라인에서 시스템 UK-REACH IT 제출;  법규 요구에 따라 조회(Inquiry) 후에야 정식 등록 추진 가능, 사전등록(Pre-registration) 또는 늦은 사전등록 (Late-Pre-registration) 없음;  행정 비용은 2017년 ECHA의 요금기준…

Aug. 17th, 2020
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