Understanding the Requirements of Food Additives in South Korea

Since food additives are consumed through processed foods,  food additives are strictly supervised and required to undergo various safety tests before being placed on the market in many countries. In South Korea,the Ministry of Food and Drug (MFDS) regulates food additives through a well-established safety management mechanism. However, complex regulations and language barriers make it difficult for many foreign companies to learn compliance requirements and enter the Korean market. To help overseas enterprises have a better understanding of Korea’s food additive requirements, we invited Jihyun Kim, a regulatory specialist from REACH 24H Korea. She will provide a comprehensive understanding of Korea\’s food additive regulations, including the classification of food additives, approval of new food additives, and recently revised regulations. Contents Introduction of the food additives Regulations on food additives How to register new ingredients Classification of food additives  Q&A Schedule Date Time (GMT+8) World Clock Language 2022-12-09 16:00 ~ 17:00…

Nov. 24th, 2022

CRAC 2022 | Deep Dive into the Global Cosmetic Sustainability Policies and Regulations

CRAC 2022 – Cosmetic Compliance Management Session With the increasing global concerns over climate, environment, and energy issues, cosmetic sustainability has gained significant momentum throughout the world recently, leading to a boosting market volume. As per Kline Market Research, the sustainable beauty market was estimated at $39 billion in 2019 and could grow by 5.7% to $48 billion in 2024. More and more companies are making sustainability a core principle of their business strategies. In response to the emerging and promising market, global governments have successively introduced regulations for cosmetic sustainability, such as microbeads ban, eco-label, packaging recycling, etc. In this panel discussion, CRAC 2022 invites experts from the Independent Beauty Association (IBA), Cosmed and REACH24H Korea to expound on the latest regulatory requirements of sustainable cosmetics in the world’s important beauty markets, as well as the sustainability-related practices and initiatives of some beauty giants, so as to provide references and suggestions for enterprises…

Nov. 24th, 2022

How to Submit New Drug Application (NDA) in China

Encouraging the development and marketing authorization of new drugs has been a highlight in China\’s reform started in 2015 for improving the drug review and approval system.Expedited programs have been launched for the Center for Drug Evaluation (CDE) to prioritize the review and accelerate the approval of new drugs with significant clinical value, especially orphan drugs for rare diseases, pediatric drugs, drugs for major infectious diseases, and drugs urgently needed for public health.Also, China has become more integrated into the international drug regulatory system since joining the ICH in 2017. Thus, China\’s regulatory environment is improving for overseas new drugs to seek marketing authorization.With total drug sales scoring 1,558.5 billion yuan (circa 214.9 billion USD) in 2021, China continues attracting drug companies as a considerable pharmaceutical market. To help pharma companies register new drugs in China, this webinar will introduce the regulatory requirements for submitting new drug applications (NDAs) to…

Nov. 22nd, 2022

How to Submit New Drug Application (NDA) in China

Encouraging the development and marketing authorization of new drugs has been a highlight in China\’s reform started in 2015 for improving the drug review and approval system.Expedited programs have been launched for the Center for Drug Evaluation (CDE) to prioritize the review and accelerate the approval of new drugs with significant clinical value, especially orphan drugs for rare diseases, pediatric drugs, drugs for major infectious diseases, and drugs urgently needed for public health. Also, China has become more integrated into the international drug regulatory system since joining the ICH in 2017. Thus, China\’s regulatory environment is improving for overseas new drugs to seek marketing authorization. With total drug sales scoring 1,558.5 billion yuan (circa 214.9 billion USD) in 2021, China continues attracting drug companies as a considerable pharmaceutical market. To help pharma companies register new drugs in China, this webinar will introduce the regulatory requirements for submitting new drug applications…

Nov. 22nd, 2022

Pharmacovigilance: how to comply with China\’s Good Pharmacovigilance Practices (GVP)?

Pharmacovigilance is an important obligation for life sciences companies. Pharmacovigilance (PV), also known as drug safety, should be monitored throughout the use of medicines because adverse reactions may emerge in patients. China’s Good Pharmacovigilance Practices (GVP) Pharmacovigilance activities are defined as activities to monitor, identify, evaluate and control adverse drug reactions (ADRs) and/or other negative reactions related to medication. China National Medical Products Administration (NMPA) released the Good Pharmacovigilance Practices (GVP), which has been effective since Dec. 1, 2021. GVP requires drug marketing authorization holders (MAHs) and drug registration applicants to establish and improve pharmacovigilance (PV) systems as well as conduct pharmacovigilance activities compliantly. Pharmacovigilance activities are subject to national and provincial medical products administrations\’ inspections according to the Pharmacovigilance Inspection Guidelines. China\’s Good Pharmacovigilance Practices (GVP) Chapter 1: General Principles Chapter 2: Quality Management § 2.1 Fundamental Requirements § 2.2 Internal Audit § 2.3 Management Entrusted to a Third-party Chapter 3: Personnel and…

Nov. 21st, 2022

MEE Order No. 12: Supervision Cases and Practical Experience Sharing

Effective from January 1, 2021, The Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12) has been strictly promoted by the Ministry of Ecology and Environment of the P. R. China. In particular, a new pollutant control action plan issued by the General Office of the State Council on May 4, 2022, stipulates that more efforts are needed to manage, register and supervise new chemical substances entering China by putting in place a national-local law enforcement mechanism, highlighting the role of chemical management and registration in preventing potential pollutants. This webinar will interpret the supervision trend according to the specific cases of on-site inspection, and learn how to fulfill the post-registration obligations. Meanwhile, with REACH24H’s enriched practical experience, we will also analyze the difficulties commonly encountered by enterprises in the actual registration work, e.g., the polymer notification and the simplified registration, hoping to help enterprises…

Nov. 21st, 2022

Market Access Strategy: why is it important for pharmaceutical companies and how to improve it?

Market access strategy is significant to win in the target market. A good market access strategy enables pharmaceutical companies to provide safe and effective therapy to patients and realize economic success with demonstrated clinical value. However, pharmaceutical companies may find a series of challenges when seeking market access: Limited knowledge of the regulations in the target market; Unfamiliarity with the procurement, pricing, and reimbursement policies; Inadequate understanding of supply chains and sales channels; Unclear profile of the patient group and unmet needs; Insufficient product differentiation, etc. To address the challenges, BaiPharm can be your helpful regulatory partner. Instead of adopting the one-size-fits-all approach, we propose a customized strategy for each product based on our meticulous market research, deep understanding of regulations and policies, efficient communications with regulators, and close network with industry stakeholders. We will leverage our expertise in assisting our clients to ensure quality management during the product’s whole…

Nov. 17th, 2022

Overview of Cosmetic Labeling and Claims Regulations in the EU, UK, US and Canada

Just as attractive labelling is one of the product\’s most important features in sales, so is correct labelling essential for the compliance of the cosmetic product with the cosmetics regulations around the world. In this webinar, Mr. Tadej and Ms. Tjaša from CE.way will interpret the labelling regulations in the EU, UK, US and Canada – requirements and very specific labelling rules, which must be followed if enterprises want to sell cosmetic products in these four regions. They will also discuss if it is possible to design one label to ensure compliance in all four markets. Additionally, they will focus on the claims that enterprises can put on the cosmetic product labels in those markets and ways to prove them. Notes: Please feel free to send us questions before, during or after the webinar; The presentation deck and recording video will be uploaded to this webpage after the webinar; If you…

Nov. 17th, 2022

DMF Filling for Active Pharmaceutical Ingredients, Excipients and Packaging Materials

DMF: Drug Master File; API: Active Pharmaceutical Ingredient Legal Basis Drug Administration Law of the People’s Republic of China (2019 Revision); Provisions for Drug Registration; Announcement No. 146 of CFDA, 2017: Announcement of Adjustment on the Review and Approval Procedure of APIs, Pharmaceutical Excipients and Packaging Materials; Announcement No. 56 of NMPA, 2019, Announcement of Improvement on the Separated Filing and Linked Review System of Drug Products and the Supervision. Product Scope APIs, pharmaceutical excipients, and packaging materials are developed, produced, imported and used within the territory of the People’s Republic of China. Applicant Qualification Chinese manufacturers of APIs, pharmaceutical excipients and packaging materials. Overseas manufacturers or holders of APIs, pharmaceutical excipients and packaging materials. For overseas applicants, a Chinese business entity must be appointed as a local agency. Filing Type and Procedure APIs filing, change management and annual report; Pharmaceutical excipients filing, change management and annual report; Packaging materials…

Nov. 16th, 2022

Clinical Trial Application, Bioequivalence Study, and Multi-Regional Clinical Trials in China

CTA: clinical trial application; BE study: bioequivalence (BE) Study; MRCTS: multi-regional clinical trials Legal Basis Drug Administration Law of the People’s Republic of China (2019 Revision); Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China (2019 Amendment); Measures for the Administration of Drug Registration (2020 Revision); Announcement No. 50 of NMPA, 2018, Announcement on the Adjustment of Review and Approval Procedures for Clinical Trials of Drugs. Registration Scope Clinical trial application (CTA) for drug market approval within the territory of the People’s Republic of China. Eligibility of Applicants An applicant shall be an enterprise or drug development institution that can assume corresponding legal responsibilities. Overseas applicants must entrust a China business entity as their local agency. Application Procedure Clinical trial application (CTA) of innovative new drugs and improved new drugs Our Services Application for Pre-IND meeting and preparation of relevant meeting materials; Feasibility assessment/data…

Nov. 16th, 2022
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