Chemical products are used in a variety of sectors in the Life sciences industry. Pharmaceuticals and cosmetics sectors are a few among them.
- December 21, 2020 Chemicals, Cosmetics Regulatory Services, Regulatory Affairs
- December 9, 2020
Ministry of Ecology and Environment (MEE) of China published the revised law for new chemical substances on May 7, 2020, which is said to be replacing the existing legislation, MEP Order 7, from Jan 1, 2021. The new update focuses on the major changes that MEE Order 12 has introduced and their implications for the industry from a legal standpoint. Let us have a brief look at it.
- December 9, 2020 Cosmetics Regulatory Services, Regulatory Affairs
The Product Information File (PIF) is one of the key elements for ensuring successful market entry of a cosmetic product in the European market. As per the Cosmetic Regulation 1223/2009, a PIF helps the concerned authorities of the European Union (EU) to monitor the safety of cosmetic products available in the market.
- December 9, 2020 Medical Devices, Regulatory Affairs, Regulatory Labeling
e-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals.
- December 9, 2020 Chemicals, Regulatory Affairs
Biocidal Products protect humans, animals and materials against harmful organisms like bacteria. Biocidal product regulation (BPR) aims to ensure a high level of protection for humans and environment and improve the functioning of the Biocidal products’ market in the European Union (EU).
- December 9, 2020 Chemicals, Regulatory Affairs
The European Commission (EC) has provided clarification on the deadlines for updating their REACH registration dossiers. The requirement to update the dossiers ‘without undue delay’ is specified as three (3) months in most cases and up to twelve (12) months in complex cases.
Medical Face Masks and Particulate Respirators - Decode SFDA’s Requirements and Recognized Standards
December 9, 2020 Medical Devices, Regulatory AffairsAs it is well known, Medical masks to be launched in the Kingdom of Saudi Arabia (KSA), must obtain Medical Devices Marketing Authorization (MDMA). In reference to the same, the Saudi Food and Drug Authority(SFDA) has recently released a guidance to specify and clarify the requirements and recognized standards to streamline products’ market-entry.
- December 9, 2020 Food and Food Supplements
To market a dietary supplement with a “New Dietary Ingredient (NDI)” in the United States (US), manufacturers are required to submit a notification to the Food and Drug Administration (FDA). This requirement falls under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and it is aimed at ensuring the safety of ingredients used in dietary supplements under the specified and recommended conditions.
- December 3, 2020 Pharmaceuticals, Regulatory Affairs
The NPRA Malaysia has updated, “Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration” - Version 5.0 (June 2020). The guidance helps API manufacturers to expedite the registration process. Further to this update, a temporary notice on mode of DMF submission has also been provided as below.
- December 3, 2020 Cosmetics Regulatory Services, Regulatory Affairs
Imported Cosmetic products are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. For importing Cosmetics in India, the products are required to be registered with the Central Drugs Standards Control Organization (CDSCO) by giving an application in Form 42 to obtain the Registration certificate in Form 43.