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Japan’s Chemical Substances Control Law (CSCL) goals to prevent environmental pollution caused by chemical substances that pose a risk to human health and interfere with the habitat and healthy development of flora and fauna. (Act on the Evaluati
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The additions include three substances that are toxic to reproduction and one endocrine disruptor. The Candidate List of substances of very high concern (SVHCs) now contains 209 substances that may have serious effects on people or the environment.
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11th – 12th November, 2020 | Koelnmesse, Germany.
Chemspec Europe, which is Europe’s major sourcing and networking event for fine and speciality
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South Korea enacted the Act on Risk Assessment of on July 27, 2021. This Act aims to protect and promote public health by evaluating risk assessment of products applied to the human body and regulating matters of safety management.
The Ministry of
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Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice ‘specifications’ for cosmetics. This notification
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The Health Canada’s revised in-commerce list (R-ICL) of
chemicals used in food, drugs, and cosmetics no longer includes 602 substances
that are not commercially active. These substances are therefore not subject to
notification under the Food an
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The
Indian Government proposes a new Draft National Policy for Medical Devices,
2022, to reduce India's reliance on high-end medical device imports. The government
intends to adopt public-private partnerships to reduce healthcare costs,
increase
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US EPA on the 29th of April 2022, submitted a notification to World Trade Organization, to amend the regulatory decision on Volatile Organic Compounds (VOCs). According to US EPA, VOCs are compounds that have a high vapor pressure and low water sol
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The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating and approving guidelines and use of Pharmaceutical drugs, sanitary standards, and regulation of the food industry. In the last month, ANVISA has proposed modifications to a
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Exemptions
There are certain chemicals that are exempt from notification, even if they meet the definition of new chemical in China. Any potential notifier should confirm if the substances fall into the range of exemption before starting the registration pr
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BACKGROUND
The chemical industry is an indispensable and integral constituent of the growing Indian The wide range of chemical products play a vital role in catalyzing not only the economy of the country, but also making the li
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The Act on the Chemical Substance Control Law came into force in 1973 to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. But it was later updated and amended on May 20th 2009. Full implement
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Substances imported or manufactured in quantities = 1 t/y in Japan, polymers of low concern, intermediates and export only substances are eligible for an exemption from standard notification. Prior confirmation of this exemption status must be obt
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Scope of K-REACH
Within Scope
Substance on its own – New Substances(1) and Existing Substances
Substance in a mixture
Product(2) containing priority control substance
Out of Scope
Naturally occurring substan
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Exemptions
The Regulations shall not apply to any of the following substances or articles:
Substances which occur in
Chemical substances in machines or equipment for test run
Inseparable intermediates from chemical reactions in the reaction vessel or produ
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The appointment of a US Agent is a mandatory requirement for foreign companies who wish to sell drugs or Pharmaceuticals, medical devices, food and dietary supplements, in United States.
U.S. agent and roles and responsibilities of the U
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Background and Overview
In Brazil, there are specific laws that apply to Pharmaceutical products, cosmetics, pesticides, sanitizing products and explosives. However, there is no law applicable to industrial chemicals. In Oct 2018, the National Chemicals Safety Commission (C
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Scope of the Regulation
The draft law mainly applies to >=1t/y industrial chemical substances. According to the article 3 of the draft law, the following chemical substances are out of scope.
Radioactive substances
Substances in development or solely for research
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Scope of K-BPR
Within scope
Consumer chemical product (1)
Biocidal substance (2)
Biocidal product (3)
Biocidal treated product (4)
Out of scope
Consumer chemical products and biocidal chemicals used for
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Summary of 29 Mandatory BIS Standards
Chemicals
Indian Standards
Title of Indian Standards
Date of Notification - WTO
Final date for comments
Reason / objective
Description
(1).
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Labelling
The product label is the primary and most effective means of communicating to users' critical information about pesticide and veterinary drug use that is both safe and effective. Current pesticide and veterinary medicine labelling, on the other h
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Fee Structure
Serial No.
Fee Type
Amount/Pricing
01.
Marketing-authorisation application (single strength, one Pharmaceutical form, one presentation)
From €296,500
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Legal Basis and the Authorities
The Reorganization and Rationalization Plan for Special Public Corporations that was approved in a Cabinet meeting in 2001, was followed by the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA) and came into service on April 1, 2
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Japan- Medical Devices
The Reorganization and Rationalization Plan for Special Public Corporations that was approved in a Cabinet meeting in 2001, was followed by the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA) and came into service on April 1, 2
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Legal Basis
The Reorganization and Rationalization Plan for Special Public Corporations that was approved in a Cabinet meeting in 2001, was followed by the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA) and came into service on April 1, 2
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Approval Process
Medical device companies interested in offering their products in Japan must comply with Japan's Pharmaceuticals and Medical Devices Act (PMD Act). Complying with the PMD Act can be challenging for foreign manufacturers, as very few regulatory do
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The Cosmetic Act
The Cosmetic Act is issued by the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, and it is supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labour and Welfa
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Scope
According to Article 2.3 of the Pharmaceutical Affairs Law, “cosmetics” is defined as articles with mild action on the human body which are intended to be applied to the human body through rubbing, sprinkling or other similar methods, aiming to c
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Products- Inclusions & exclusions
Any products having Pharmaceutical characteristics such as those affecting or altering the functions or structure of human body or presenting as Pharmaceutical products are outside the scope of cosmetic regulation. List of names of cosmetic product
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Toxic Substance Control Act
Any chemical that is imported or made in the United States but is not listed by the Environmental Protection Agency (EPA) is a novel chemical that should be added to the list before being sold in the United States. The Toxic Substances Control Act (T
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Regulatory Framework of Nano-Pharmaceutical
A nano Pharmaceutical is a Pharmaceutical preparation that contains nanomaterials for internal or external use on the body for treatments, diagnostics, or any other health benefit, and that contains materials with a size scale of 1 to 100nm in at lea
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Nanomaterial Regulation- Various Sectors
Nanomaterials have been used in Japan for some time in products such as home appliances, food, food containers, cosmetics, automobile parts, Pharmaceuticals, paints and inks, and textiles.
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Nanomaterials Safety Management Committee- Japan
It focuses on nanomaterial exposure in goods and to develop suitable management processes from the standpoint of usage and life cycles. Following its first meeting in December 2011, a report describing three major topics of debate was issued in Janua
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