2024-04-04 04:44
In an era of rapid technological advancements, the integration of Artificial Intelligence (AI) is reshaping compliance processes in the Consumer Packaged Goods (CPG) and Life Sciences indust… Read More
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Regask® Blog
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Tags:
compliance
updates authorized plants
green claims directive
human expertise
regulation banning bpa
dietary supplement regulation
claims directive penalties
material
aligns dietary supplement
advertising advisory board
RegASK is a global, RegTech company, automating regulatory research to empower informed strategies.
Operator to help firms’ International Trade, Regulatory and Government Affairs become a more proactive player and key contributor to marketing and strategic decisions by facilitating compliance in global markets through innovative powered-by-Artificial Intelligence SaaS solutions, supported by outstanding strategic advisory.
The company's platform offers a full scope of services including real-time ESG regulatory monitoring and risk prediction, compliance, path-to-market, path-to-claim, product registration and regulatory strategy for the food, dietary supplement, cosmetic, personal care and medical device industries, enabling clients to reduce time and costs involved in regulatory research, allowing them to focus on core competencies.
2024-02-26 07:07
In an era marked by global interconnectedness and rapid information dissemination, businesses grapple with complexities in reputation managemen… Read More
2024-02-21 12:07
The Ministry of Public Health in Thailand has unveiled a draft notification outlining updated dosage limits for drugs containing fat-soluble vitamins classified as Dangerous Drugs… Read More
2024-02-21 11:53
The Internal Market and Environment committees of the EU Parliament have adopted their position on the draft Green Claims Directive, marking a significant step in combating deceptiv… Read More
2024-02-21 11:23
Health Canada is currently scrutinizing a significant revamp of pharmaceutical advertising standards proposed by the Pharmaceutical Advertising Advisory Board (PAAB).
The primary fo… Read More
2024-02-21 10:56
The Therapeutic Goods Administration (TGA) Australia is actively seeking public input on the adoption of thirteen international scientific guidelines.
This comprehensive feedback pr… Read More
2024-02-21 10:37
The European Commission presents a draft regulation aiming to restrict the use of bisphenol A (BPA) and other bisphenols in materials and articles intended for food contact.
The… Read More
2024-02-21 05:43
The UK Government has released an official report highlighting key findings and a positive verdict on the sustainability of Malaysian palm oil.
Simultaneously, on February 9, 2024… Read More
2024-02-21 05:22
Belgium has published a significant update through an Order that revises the list of plants authorized in both food and food supplements.
This Royal Order, amending the initial Order… Read More
2024-02-21 05:10
Ukraine informs the World Trade Organization of a draft law aligning its dietary supplement regulation with EU standards.
The proposal establishes a notification process and a pu… Read More
2024-02-21 04:43
Thai FDA proposes a draft Notification mandating annual safety reports for terminated or completed clinical research, aligning with Herbal Products Committee standards.
These reports… Read More
2024-02-21 04:28
The FDA’s latest guidance outlines crucial considerations for developing Chimeric Antigen Receptor (CAR) T cell products.
Focused on safety, manufacturing, and clinical stud… Read More
2024-02-07 05:13
FDA allocates $2 million for institutions conducting a Human Abuse Potential (HAP) study on botanical Kratom due to rising concerns over its increased use.
With an estimated 1.7 mill… Read More
2024-02-07 04:27
On December 25, 2023, Thailand’s MoPH published the announcements on the prohibition on selling kratom leaves, or food containing kratom as a raw material or ingredient.
&nbs… Read More
2024-02-07 04:13
The Therapeutic Goods Administration (TGA) has repealed the Advertising Permission for Nicotine, effective from 1 January 2024.
This move comes as part of the ongoing reform… Read More
2024-02-07 03:46
New research indicates a higher risk of neurodevelopmental disorders in children when fathers took valproate three months before conception.
The Medicine and Healthcare products Regul… Read More
2024-02-07 03:31
California Assembly Bill 82, addresses the sale of weight loss supplements to minors, introducing essential regulations. Initially introduced on December 15, 2022, after Governor Ga… Read More
2024-02-06 06:01
The Government of Canada, via Environment and Climate Change Canada, opens a 45-day public comment period until February 13, 2024, for proposed plastic reporting in 2024-2026.
The… Read More
2024-02-05 03:41
RegTech platform awarded crucial certifications, underscoring its commitment to data security and privacy
RegASK, the global RegTech empowering businesses to leverage AI in scaling regulato… Read More
2024-01-23 03:31
ANVISA (Brazil) Introduces Streamlined Processes for Importing Experimental Medicines: New procedures exclude pre-boarding inspections for drugs…… Read More
2024-01-23 03:31
FDA Implements 21st Century Cures Act: Effective 30 days post-publication, ensuring rights and safety of human subjects. The final rule amendment allows exceptions for informed conse… Read More
2024-01-23 03:29
Colombia’s Ministry of Health and Social Protection Unveils Regulatory Impact Report on Sports Foods.
The essential insights on the need for specific regulations, including defi… Read More
2024-01-23 03:29
Taiwan FDA Implements New Regulations: Highlights include warnings for Devil’s claw leaves, Gerbera Stemmed Chrysanthemum, Noni leaves, and Psyllium husks in food products.
&nb… Read More
2024-01-23 03:29
On 8 January 2024, the U.S. Food and Drug Administration (FDA) announced the availability of SPL Xforms, a Structured Product Labeling (SPL) authoring tool for cosmetic product faci… Read More
2024-01-23 03:28
The UK’s largest plastic bag and wrapping collection trial, a part of the Flexible Plastic Fund’s initiative, reveals positive results. Pilot feedback shapes future nati… Read More
2024-01-12 09:14
On December 14, 2023, the European Commission released Commission Implementing Regulation (EU) 2023/2785, modifying Implementing Regulation (EU) 2021/2325 concerning the acknowl… Read More
2024-01-12 09:13
The NPRA has released a revised edition of the biosimilar product registration guidelines in the second edition of the Guidance Document and Guidelines for Registration of Biosimila… Read More
2024-01-12 09:13
ANVISA issued Resolution 837/2023 on December 15, outlining updated procedures for clinical investigations supporting higher-risk Medical Devices (Classes III and IV) registration.
T… Read More
2024-01-12 09:10
The U.S. Food and Drug Administration (FDA) issued a crucial final guidance on cosmetic product facility registrations and product listings, in compliance with the Modernization of Cosmetics… Read More
2024-01-06 06:11
An article by Deniz Ataman for foodnavigator-usa.com
RegASK’s digital platform leverages AI to help food and beverage manufacturers remain compliant and c… Read More
2023-12-27 07:25
The Mexican Senate has endorsed a draft law prioritizing the right to adequate and sustainable food.
The legislation emphasizes health, environmental, water, and children&r… Read More
2023-12-27 07:18
IDEC has initiated a campaign focusing on changes in nutritional information table and the implementation of front-of-pack labeling, complying with new regulations from the National H… Read More
2023-12-27 05:06
Parliament overwhelmingly supports a strengthened “right to repair” with 590 votes in favor, aiming to promote sustainable consumption.
The move aligns with EU goals fo… Read More
2023-12-27 05:05
The European Union (EU) is considering far-reaching legislation on artificial intelligence (AI) known as the Artificial Intelligence Act and aims to classify AI systems by risk and mand… Read More
2023-12-27 04:42
The European Commission has approved the 10-year renewal of glyphosate, a controversial herbicide.
The decision aligns with EU legislation, triggered when a qualified… Read More
2023-12-27 04:40
Originally introduced in 2019 to clearly differentiate alternative proteins from animal proteins on product labels, US Senator Fischer is now reintroducing the Real MEAT Act, aiming to… Read More
2023-12-19 06:49
The NMPA has sought opinions on draft provisions for Toothpaste Notification Documentation Management, effective December 1, 2023.
The basic requirements include the scope of applicat… Read More
2023-12-19 06:47
FSSAI has framed a draft Food Safety and Standards (Food Product Standards and Food Additive) Amendment Regulations with regards to the limit of micronutrients Vitamin and Mineral Premix for… Read More
2023-12-08 02:31
Health Sciences Authority (HSA) of Singapore has issued a public alert regarding four products sold online that were found to contain potent or banned ingredients, including high levels… Read More
2023-12-08 02:30
This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in the development of drugs to ensure that translation of a study report into English from… Read More
2023-12-08 02:28
In a joint effort, the Therapeutic Goods Administration (TGA) and Australian Border Force (ABF) successfully seized over $2 million worth of unlawfully imported medicines and medical devi… Read More
2023-12-06 02:01
Revisions to the Codex Standard for Follow-up Formula (CXS 156-1987) were adopted on 28 November by the Codex Alimentarius Commission. The text was renamed to “The Standard for Fo… Read More
2023-12-04 09:32
German Federal Minister of Food and Agriculture, Cem Özdemir, unveiled the “National Strategy for 30% organic agriculture and food industry by 2030”, or “Organic… Read More
2023-12-04 09:31
The Federal Trade Commission (FTC) has issued warning letters to two trade associations and 12 health influencers, including dieticians, for inadequate disclosures in their Instagram… Read More
2023-12-04 09:28
FSANZ has approved a variation resulting from the proposal “P1062 Defining added sugars for claims” and has notified the approval to the Food Ministers’ Meeting… Read More
2023-12-01 07:03
An article in partnership with medtechintelligence.com, written by Caroline Shleifer, the CEO and founder of RegASK, a RegTech company that employs cutting-edge technology… Read More
2023-12-01 03:37
The cosmetic industry is witnessing a post-pandemic renaissance, with sales on an upward trajectory, set to reach $580 billion by 2027, at a projected growth rate of 6% per year. Simultaneou… Read More
2023-11-28 02:47
Parliament, business, and academics reflect on the challenge of the 2030 target to reduce emissions by 50 percent and identify innovative ways to ‘green’ the nation.
Res… Read More
2023-11-28 02:37
ANVISA has updated its import authorization procedures for medicines and substances subject to special control. It is worth remembering that those products that don’t fall under… Read More
2023-11-28 02:35
Argentina ANMAT guide outlines the requirements for decentralized elements in clinical pharmacology studies, including roles and responsibilities for the sponsor and investigators, Infor… Read More
2023-11-07 00:36
NEW YORK CITY and SINGAPORE, November 2, 2023 – RegASK, a global regtech SaaS platform that enables businesses to leverage AI to scale their regulatory and compliance capabilities… Read More
2023-11-06 06:47
Article and case study written in collaboration with Life Science Law – Legal experts in life science industry laws and regulations; providing practical solutions to business challenge… Read More
2023-10-11 01:30
Malaysia has released its first Decentralised Clinical Trial guidance document, which provides detailed guidance on implementing decentralised elements in clinical trials. The document was d… Read More
2023-10-09 02:19
On September 25th, 2023, the NHC Released an announcement on the release of 85 national food safety standards and 3 amendment documents.
The 85 national food safety standards include 3 p… Read More
2023-10-06 06:54
The ever-evolving landscape of medical devices requires robust regulatory pathways to approve these innovative solutions. This fact is especially true for regulatory affairs professionals in… Read More
2023-10-06 02:10
An NIH-funded team has developed a miniature device with the potential to predict the therapeutic option that will work best for a given tumor, changing the narratives for the approximatel… Read More
2023-10-04 01:00
On 20 September, the new provision of the General Health Law that restrict trans fats entered into force. It is worth recalling that this article establishes the following:
“Edible… Read More
2023-10-02 07:11
This report provides an update on global progress towards ending hunger and malnutrition, as well as estimates on the number of people who cannot afford a healthy diet. It highlights th… Read More
2023-09-15 02:10
Korea Ministry of Food and Drug Safety (MFDS) proposed a partial revision of the “Enforcement Rules of the Special Act on Children’s Dietary Safety Management” through… Read More
2023-09-13 02:10
Indonesia BPOM published a Decree on Product Information File (PIF).
The Decree provides guidelines for cosmetic product information documents. The purpose of the regulation is to ensure t… Read More
2023-09-11 02:10
The public consultation by Legal Documentation and Information Network of the Indonesian Food and Drug Administration (BPOM) is for Articles 34, 35 and 37 (2).
The Article 34 of the draft… Read More
2023-09-08 02:10
The European Commission has adopted a new Regulation (EC) No 2023/1545 amending Regulation (EC) No 1223/2009 of the European Parliament and the Council as regards labeling of fragrance alle… Read More
2023-09-06 02:20
MOH Malaysia has revised the labeling requirement under Food Regulation 1985 which will be implemented effective from January 1, 2024.
Labeling of QUID (Quantitative Ingredient Declarat… Read More
2023-09-04 03:00
TGA Compliance Priorities for 2023-24 Regarding Medicinal Cannabis Advertising and Wellness and Beauty Industry. The TGA has published its import, advertising, and supply compliance pri… Read More
2023-09-01 02:50
Brazilian National Commission on Ethics in Research – CONEP/CNS has published on its website a Circular Notice, which provides guidance on implementing Article 26 of Resolution CNS 6… Read More
2023-08-31 02:45
The Turkish Food Codex Regulation Proposed Draft Turkish Food Codex Regulation, specifically the Amendment of the Turkish Food Codex Regulation on Specifications for Food Additives. Th… Read More
2023-08-30 08:38
The Taiwan Food and Drug Administration (FDA) has proposed an amendment to “Establishment of food safety monitoring programs, food manufacturers that should be inspected, minimum… Read More
2023-08-30 06:27
The cosmetic industry is witnessing a post-pandemic renaissance, with sales on an upward trajectory, set to reach $580 billion by 2027, at a projected growth rate of 6% per year. Simultaneou… Read More
2023-08-08 02:46
On 14 July 2023, the National Agency for Drugs, Food and Medical Technology (ANMAT) opened a comment period for a Draft Provision ruling the HEALTH CLAIMS for foods and non-alcoholic be… Read More
2023-08-08 02:37
Korea Ministry of Food and Drug Safety (MFDS) published a partial revision to Standards and Specifications for Health Functional Foods through Safety Notice No. 2023-50. Below is a sum… Read More
2023-08-08 01:59
On 14 July, following the publication of the results of the hazard and risk assessment of aspartame, ANVISA re-published the news and its statement about it.
It is worth recallin… Read More
2023-08-07 02:49
The UK’s ASA has made technical updates to their advertising code regarding infants and following formula foods and rules.
CAP and BCAP have made technical updates to the i… Read More
2023-08-07 02:47
USDA Updates Cell-Cultured Meat and Poultry Products Sampling Program to add instructions for sampling ready-to-eat (RTE) products.
This notice provides instructions to inspectio… Read More
2023-08-07 02:44
Health Canada announced it is reviewing the summary assessments by the WHO’s International Agency for Research on Cancer (IARC) and JECFA published on July 13, 2023, and will revi… Read More
2023-08-07 02:05
ANSA published news on the EU anti-waste label on the expiry date has been postponed.
It was expected among the measures against food waste that the European Commission will pres… Read More
2023-08-02 06:31
“In Germany, too much sugar, fat and salt in the food, even in children’s products.” Federal Minister Özdemir presents scientific product monitoring.
Ready… Read More
2023-08-02 02:00
This final guidance supersedes Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff issued on August 10, 2017. I… Read More
2023-08-01 08:16
Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene therapy.
The guideline according to ICH
Provides harmonized re… Read More
2023-08-01 01:47
MASAF, in a press-realease, published the news about the bill on the ban on the production, use, placing on the market and importation of synthetic food and feed, which has been approve… Read More
2023-07-25 06:37
Korea Ministry of Food and Drug Safety (MFDS) proposed a partial revision to Regulations on the Safety of Pharmaceuticals through Safety Notice No. 2023-333. Below is a summary of the p… Read More
2023-07-25 06:28
APCO has published details on the National Retail Association which is hosting free online webinars to help businesses in different states and territories prepare for the next round of p… Read More
2023-07-25 06:21
The U.S. Food and Drug Administration (FDA) released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapprove… Read More
2023-07-20 01:25
There have been so many changes in the clinical trial framework in Italy including four new decrees concerning clinical trials on medical devices and medicines for human use.
The Mi… Read More
2023-07-20 01:24
The use of trans fat in pre-packaged food products is now banned in the country starting Monday, June 19. This policy was implemented to address the high consumption of trans fat, which… Read More
2023-07-14 08:02
The French Decree No. 2023-478 of June 20, 2023, relating to the obligation to present for sale unprocessed fresh fruits and vegetables without packaging made wholly or partly of plastic ha… Read More
2023-07-14 08:02
Korea Ministry of Food and Drug Safety (MFDS) proposed a partial revision of Standards and Specifications for Food Additives for Food through Safety Notice No. 2023-301. Below is a summa… Read More
2023-07-14 08:01
FSANZ CEO, Dr Sandra Cuthbert, has released a statement concerning the current International Agency for Research on Cancer (IARC) and Joint FAO/WHO Expert Committee for Food Additives (… Read More
2023-07-10 03:08
On June 23rd, 2023, The Dairy Standard Agency of South Africa added a combined list of acts, regulations and standards relating to food safety and quality aspects of milk and other dair… Read More
2023-07-10 02:57
According to FDA, this draft guidance describes the FDA’s interpretation of, and policies concerning, the prohibition on wholesaling in section 503B of the FD&C Act (21 U.S.C… Read More
2023-07-05 03:26
On 22 June 2023, the Government of Canada banned the testing of cosmetic products on animals to establish product safety, and/or the use of false or misleading labelling pertaining to an… Read More
2023-07-05 02:20
The CAA announced that they will consider adding macadamia nuts to the Semi-Specified Ingredients for which an allergen declaration is not mandated but strongly recommended.
Prior… Read More
2023-07-05 01:46
This guideline provides evidence-informed guidance on the use of non-sugar sweeteners to reduce the risk of unhealthy weight gain and diet-related noncommunicable diseases in adults and… Read More
2023-07-03 02:31
Ministry of Health (MOH) Indonesia published news about Filling in Medical Device Dictionary Data.
Based on Government Regulation No. 46 of the year 2014 about Health Information S… Read More
2023-06-26 03:14
The Federal Ministry of Food and Agriculture (BMEL) is starting the model region competition “Food Transition in the Region”. Cities, communities and districts, but also socia… Read More
2023-06-26 03:13
The U.S. Food and Drug Administration (FDA) is extending the comment period for the Draft Guidance for Industry entitled “Questions and Answers About Dietary Guidance Statements in… Read More
2023-06-26 03:13
Taiwan Food and Drug Administration published Guidelines for Decentralized Measures for the Implementation of Drug Clinical Trials. Below is a summary of the guidelines:
Purpose and Conce… Read More
2023-06-20 06:19
On 8 June 2023, the European Commission notified the WTO of a new amendment to the Cosmetic Regulation (CPR). The publication is amending Regulation (EC) No 1223/2009 of the Europ… Read More
2023-06-20 06:07
MFDS published partial revision to Imported Food Safety Management Special Act through Prime Minister Ordinance No. 1879. Below is the summary of the revision:
Effective Date: Thi… Read More
2023-06-20 06:00
UK’s MHRA announced the Software and AI as a Medical Device Change Programme last year to ensure regulatory requirements for software and AI are clear and patients are protected.
&n……Read More
2023-06-13 02:38
The Thai Food and Drug Administration (TFDA) has published regulations regarding the nutrition labeling and energy value, sugar, fat, and sodium requirements for food products. The not… Read More
