Freyr Blog

Personal Care Products Safety Act: Is an Update on The Way?

May 23, 2019 Cosmetics Regulatory Services, Regulatory Affairs

The global personal care products industry is currently valued at USD 13.2 billion approximately and is expected to grow furthermore in the coming years. With the increase in numbers, the United States Senate has proposed a Personal Care Products Safety Act, a bill, to strengthen the regulations of ingredients of personal care products and protect consumer health.

While the Food and...

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Indonesian Halal Regulations & The Industry’s Concerns

April 15, 2019 Cosmetics Regulatory Services, Nutraceuticals/Food Supplements, Regulatory Affairs

According to the Indonesian Law no. 33/2014, Cosmetics or Food Supplement manufacturers in Indonesia are required to obtain a halal certificate before their distribution in the country. The halal product regulations were supposed to come into effect from October 2019. But in recent turn out of events, according to the new plan of Halal Product Assurance Agency (BPJPH), manufacturers will...

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Cosmetics and The Ban on Animal Testing - Where Does the World Stand?

April 10, 2019 Cosmetics Regulatory Services, Regulatory Affairs

Animal testing has always attracted a lot of attention from the industry because of its controversial nature. From the last decade, Cruelty Free International (CFI) has been encouraging companies across the world to stop the testing of cosmetics on animals to create a harmonized, cruelty free global market. Even though a lot of companies claim to be cruelty free, many still rely on animal...

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Health Canada Revises Validation Rules for Regulatory Transactions In eCTD Format

April 8, 2019 Regulatory Affairs, Publishing & Submissions

Health Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019. The Agency reported that the latest version of the rules, meant to educate the stakeholders in preparation and submission of Regulatory transactions in eCTD format, will be effective from March 30...

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Structured Product Labeling (SPL) and 3 Major Challenges to Overcome

April 4, 2019 Regulatory Labeling, Regulatory Affairs

In January 2006, the United States Food and Drug Administration (US FDA) introduced Structured Product Labeling (SPL) format for submitting product and facility information and changes to label submissions. The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content. When...

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South Korea Cosmetics/Beauty Market
A Preliminary Report

March 27, 2019 Cosmetics Regulatory Services, Regulatory Affairs

The Korean beauty market is valued at USD 13 billion, making it one of the top 10 beauty markets in the world and offering a pool of business opportunities for manufacturers. Most of the brands are successful in South Korea because rather than sticking to the classic brands, consumers prefer trying new products to suit their daily skin care routine. Be it customized products or textured...

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FDA Extends Deadline for DMF Type III eCTD Submissions

March 25, 2019 Regulatory Affairs, Publishing & Submissions

For the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for Type III Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format. With the deadline extended till May 5, 2020, the first and foremost question every applicant should ponder upon is, what are the DMF Type III requirements and how is the...

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Emerging Technologies and Cosmetics Compliance

March 14, 2019 Compliance, Audit and Validation, Cosmetics Regulatory Services, Regulatory Affairs

When it comes to personal care and cosmetic products, cosmetic manufacturers must adhere to the safety and efficacy Regulations to make sure their products are safe for consumption. But, with their continuous focus on new inventions to meet the market and competitive demands of consumers’ ever-growing beauty consciousness and their ingredient choices, manufacturers may miss out keeping a tab...

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8 New Additions to CDSCO’s List of Regulated Medical Devices

March 13, 2019 Medical Devices, Regulatory Affairs

Do you know? Out of 5000 types of medical devices marketed in India, only 23 types are currently regulated by the Central Drugs Standards Control Organization (CDSCO). To increase the ambit of Regulatory supervision and ensure efficacy and safety of medical devices, in early 2017, the CDSCO drafted and published the Medical Device Rules – 2017, which were made mandatory from January 1, 2018....

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Spinal Implantable Medical Devices Decode TGA’s Proposal for Reclassification

March 11, 2019 Medical Devices

Australia’s Therapeutic Goods Administration (TGA) published a consultation paper on 11th February 2019 to receive effective feedback from the industry regarding the proposal of reclassifying spinal implantable medical devices to a higher level of classification. The proposal is an effort by the TGA to align its Regulatory requirements with that of the European Union’s Medical Device...

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