CIRS Group regulatory news – 10 December 2022

Welcome to our final issue for 2022. We'll be taking a break until the middle of January and would like to take the opportunity to wish you a lovely holiday season and a prosperous new year.

This issue brings you updates on South Korea's consultation on the first batch of candidate substances subject to authorization, additions to Australia's inventory and explanations on the use of clinical trial data for medical devices in China.

We also bring you three longer articles that cover:

• How to Apply for China’s Sanitary Administrative License for “Three New” Disinfection Products;
• Regulations on the Referencing of Clinical Trial Data for Medical Devices in China; and
• How Do You Clearly Distinguish Between Probiotics, Prebiotics, Synbiotics, and Postbiotics?

There is an exciting opportunity to join our global team as a Senior Regulatory Affairs Specialist (Cosmetics) in the US.

We'd also like to hear from you if there are webinar topics that we haven't covered this year and you'd be interested in hearing more about them in 2023.

Chemical news

South Korean MoE Consults on the First Batch of Candidate Substances Subject to Authorization

On November 23, the South Korean Ministry of Environment (MoE) published 11 candidate substances subject to authorization (also known as substances subject to permission) for public consultation. Comments can be made from December 15, 2022, until February 13, 2023.

Companies producing, importing, or using substances subject to authorization under K-REACH are required to obtain approval from MoE prior to commencing activities in the country. This applies even registrations under K-REACH have already been completed for the substances.

To see the full list and understand the designation process please click the link below.

Our managing editor Ellen Daliday also prepared this article explaining more about the process of designating these chemicals for the November/December issue of Speciality Chemicals Magazine.

Eight Substances Added to Australian Inventory of Industrial Chemicals

On November 16, Australia added eight substances into the Australian Inventory of Industrial Chemicals (AIIC) and revoked the CBI approval of one substance under the requirements of the Australian Industrial Chemicals Act.

The substances are:

• 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate and 2-propenenitrile;
• Cyclotetrasiloxane, 2,4,6,8-tetramethyl-, reaction products with 1,1′-(methylethylidene)bis[4-(2-propen-1-yloxy)benzene];
• Propanedioic acid, 2-[(4-hydroxy-3,5-dimethoxyphenyl)methyl]-, 1,3-bis(2-ethylhexyl) ester;
• Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated, polymers with 1,4-butanediol, 1,6-diisocyanatohexane and 2-hydroxyethyl-terminated hydrogenated polybutadiene, stearyl alc.-blocked;
• Neodecanoic acid, ethenyl ester, polymer with butyl 2-propenoate and ethenyl acetate;
• 1,2-Cyclohexanedicarboxylic acid, 1-[2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl] ester, polymer with butyl 2-propenoate, ethenylbenzene, 2-hydroxyethyl 2-methyl-2-propenoate and methyl 2-methyl-2-propenoate, 2,2′-(1,2-diazenediyl)bis[2-methylpropanenitrile]-initiated;
• 2-Propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-hydroxyethyl 2-methyl-2-propenoate, 2-hydroxyethyl 2-propenoate, methyl 2-methyl-2-propenoate and 2-methylpropyl 2-methyl-2-propenoate, tert-Bu 2-ethylhexaneperoxoate- and 2,2′-(1,2-diazenediyl)bis[2-methylpropanenitrile]-initiated; and
• Humic acids, polymers with acrylic acid, N,N-dimethyl-2-propenamide and 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium salt, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)-initiated.

The CBI has been revoked for 1,3-Benzenedicarboxylic acid, polymer with (2E)-2-butenedioic acid, 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and hexanedioic acid, (octahydro-4,7-methano-1H-indenyl)methyl ester.

To find out more about the inventory, click the link below.

Medical devices news

What are the requirements for anticoagulants used in clinical trials of in vitro diagnostic reagents?

When different anticoagulants are involved in the test samples of in vitro diagnostic reagents, different anticoagulants should be studied in the preclinical research stage to verify their applicability and their impact on the test.

In general, it is not necessary to include samples using different anticoagulants in groups during clinical trials. All applicable anticoagulants can be used in the clinical trial samples if the available anticoagulants claimed in the instructions have no differential effect on the sample test according to the previous study.

Under special circumstances, sample collections and research should be carried out separately in clinical trials, when different anticoagulants have a significant impact on the test results, resulting in different reference values for the determination of clinical test results.

The type of sample and the anticoagulant used in the sample should be clearly stated in the clinical trial protocol and report.

You can read the article and find out more about our medical device services here.

Is it possible to choose a single-group target value design for clinical trials of intracranial drug-coated balloon dilatation catheters？

The essence of the single-group target value design is to compare the test results of the main evaluation indicators with existing clinical data to evaluate the effectiveness and safety of the test device.

Compared with parallel control trials, the inherent bias of single-group trials is non-synchronous control bias, which may cause selection bias, confounding bias, measurement bias and evaluation bias due to out of synchronization in time.

Since there is no control group, the clinical trial with the single-group target value design cannot confirm the superiority, equivalence or non-inferiority of the test device, but can only confirm that the effectiveness and safety of the test device meet the minimum standards recognized in the professional field.

You can read the full article and find out more about our recommendations and medical device services in the link below.

Longer reads

How Do You Clearly Distinguish Between Probiotics, Prebiotics, Synbiotics, and Postbiotics?

Since probiotics have become widely known in the gut health industry, terms such as prebiotics, synbiotics, and postbiotics have emerged one after another.

But what do these terms actually mean? According to a survey from the Chinese Nutrition Society (CNS) in 2022, these kinds of terms are a blind spot for consumers. In particular, 66% of consumers showed no comprehension of the word postbiotics.?

We have prepared a brief introduction on the definitions of these terms to help you to distinguish between them.

How to Apply for China’s Sanitary Administrative License for “Three New” Disinfection Products

Since the outbreak of the Covid-19 epidemic, disinfection products are far more widely used in various scenarios of daily life. Enterprises have stepped up new disinfection product development. However, it is incredibly difficult to notify a new disinfection product. There are uncertainties about the specific requirements, test items, costs, and application cycle for different products.

Based on the statistics from the National Health Commission (NHC), it has accepted 25 applications for new disinfection products notification since 2014, among which 23 applications were submitted in 2020, after the outbreak of the epidemic. So far, no products have been approved.

This article explains the "three new" concept and the application process.

Regulations on the Referencing of Clinical Trial Data for Medical Devices in China

We have prepared a Q&A covering common questions regarding clinical trials for medical devices in China. It covers the following questions:

1. Can I?select?similar products as the control products according to Chinese regulations, when conducting parallel controlled clinical trials, if I cannot use the similar products on the market as the control products due to reasonable grounds?
2. Does non-Chinese clinical trial data of the product need to fully meet the requirements of the corresponding Chinese guidelines for products with existing clinical trial data of non-Chinese medical devices? Is there are a published clinical trial guideline for corresponding products in China?
3. Is it necessary to include the Chinese trial data in the non-Chinese clinical trial data when accepting the clinical trial data of non-Chinese medical devices?
4. Are the medical devices listed in the?Catalogue of Class III Medical Devices Requiring Clinical Trial Approval?required to carry out clinical trials in China?

To find the answers, click the link below.

Job opening

Senior Regulatory Affairs Specialist (Cosmetics) US

We're recruiting a US-based senior regulatory affairs specialist to join our cosmetics division. This will be a hybrid working role based in Arlington, Virginia with the opportunity to take occasional business trips in the US and globally.

The successful candidate would have numerous responsibilities including:

• FDA Cosmetic Product Ingredient Statements (CPIS) filing and OTC notification;
• California Safe Cosmetics Program Reports;
• US Cosmetics/OTC Label/Ingredient Review;
• the Toxicology Risk Assessment (TRA) of cosmetics; and
• application of INCI name for cosmetic ingredients.

They would also be required to communicate with authorities to update the requirements for cosmetics compliance and closely cooperate with laboratories and prepare related dossiers.

Benefits include:

• 401(k);
• Medical insurance;
• Paid maternity leave; and
• Paid paternity leave.

To see the full ad on LinkedIn or apply, click the link below.

You can also view all our job openings on our website via the link below.

Webinar Topic suggestions

We have one more webinar (see below) then we'll be taking a break until 2023. If you'd like to catch up on any that you've missed over the years, you can find our back catalog of free and on-demand webinars and training courses via our?events page.

If you have topics that we haven't covered and you'd be interested in hearing more about them in 2023, then please contact our managing editor Ellen Daliday ?via [email protected], and please put "Webinar topics" in the subject line.

Free webinar

How to Register New Cosmetic Ingredients in China under CSAR

Tomorrow (December 20) and Thursday (22nd) we will present a free webinar on how to register new cosmetic ingredients in China under the CSAR. The webinar will introduce the latest regulatory system for cosmetic ingredients in China and the pre- and post-compliance requirements for new cosmetic ingredients. This aim is to assist enterprises in successfully completing the declaration of new cosmetic ingredients so that more innovative ingredients can be placed on the Chinese market as soon as possible.

You can register?here?or in the link below.

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