2022 Recap & 2023 Outlook: China Pharmaceutical Regulatory Updates

In 2022, China issued and implemented a series of drug regulations, including new rules for marketing authorization holders to manage drug quality and guidelines for pharmacovigilance inspections. Last year also saw China’s first regulation permitting online sales of prescription drugs nationwide. The regulations impact how pharmaceutical companies apply for marketing authorization, sell drug products, ensure drug safety, and fulfill other obligations. ChemLinked BaiPharm Team holds this webinar to review the significant regulatory updates, which can help stakeholders keep compliant with current regulations and prepare for the upcoming ones. Contents 1. China’s Drug Regulatory System 1.1 Main regulators 1.2 Major laws and regulations 2. 2022 Regulatory Updates 2.1 Regulations Topic New Regulation MAH Administrative Rules on Supervising Marketing Authorization Holder (MAH) as the Main Entity to Fulfill Responsibilities for Drug Quality GVP Pharmacovigilance Inspection Guidelines GMP Appendix to Good Manufacturing Practice (GMP) for Pharmaceuticals: Investigational Products Used in Clinical Trials GSP…

Feb. 13th, 2023

China\’s Good Pharmacovigilance Practices (GVP): Decoding PV Compliance in China

On May 13, 2021, 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\’ inspections according to the Pharmacovigilance Inspection Guidelines. To help pharmaceutical companies with PV compliance in China, this article introduces: 1. GVP Application Scope 2. China GVP Contents 3. Pharmacovigilance for MAHs 3.1 Pharmacovigilance System Quality Management 3.2 Pharmacovigilance System Master File 3.3 Individual Case Safety Report 3.4 Post-market Safety Study 3.5 Periodic Safety Update Report 3.6 Risk Management 4. Pharmacovigilance for Drug Applicants 1. GVP Application Scope The Chinese GVP applies to pharmacovigilance activities of   Drug marketing authorization holders (MAHs); and drug registration applicants approved to carry out clinical trials. Pharmacovigilance activities refer to activities to…

Feb. 01st, 2023

China CDE Answers Questions on Drug Application\’s Electronic Submission and More

On Jan. 11, 2023, China Center for Drug Evaluation (CDE) released 10 Q&As, including nine questions on the electronic submission of drug applications and one on the application of overseas drugs for China’s marketing authorization. Related: China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023 ChemLinked BaiPharm Portal translated the Q&As for your reference. In case of any discrepancies between the English translation and the original Chinese text, the original shall prevail. Q1: Does the applicant have to submit application documents in paper if the application was accepted by CDE after format review, and the application was received by CDE before China National Medical Products Administration (NMPA)’s Announcement on Implementing Electronic Submission of Drug Registration Applications took effect on Jan. 1, 2023? For example, the application was signed for by CDE on Dec. 30, 2022, and was accepted on Jan. 6, 2023. A1: The applicant is required to submit…

Jan. 18th, 2023

Natural & Organic Cosmetics: Market Overview, Global Trends and Compliance Requirements

As part of the beauty market, the natural & organic cosmetic sector is an innovative and growing segment for several years. In the absence of binding regulations, private certification labels, such as COSMOS, have become the standard to provide guarantees about brands’ commitments and to answer to consumers\’ expectations towards less harmful and more environmentally friendly cosmetic products. During the webinar, Pauline Raffaitin will give an overview of the natural & organic cosmetics market and some insights about the global trends to watch. Then, she will go deeper into the compliance requirements by giving some examples of regulatory constraints that apply to organic cosmetics. To finish she will also point out the differences between self-declaration such as in the “Clean Beauty” trend and third-parties labels such as COSMOS certification. Contents Market overview for natural & organic cosmetics Global trends to watch Compliance requirements Examples of regulatory constraints for organic cosmetics…

Jan. 17th, 2023

China Clinical Trial Application / Investigational New Drug Application Procedures

In July 2018, China optimized the clinical trial applications (CTA) / investigational new drug (IND) applications\’ review and approval procedures. Instead of waiting for the formal approval notification after lengthy procedures, the applicant can start the clinical trial if there are no rejection notices or questions from the Center for Drug Evaluation (CDE) within the first 60 workdays from the day when the application is accepted by CDE. This is why it\’s called implied approval. To help international pharma companies register drugs in China, this article introduces IND Applicant Qualification IND Application Scope IND Application Dossier IND Application Submission Procedures BaiPharm\’s IND Application Service 1. IND Applicant Qualification Domestic applicants should be companies or drug research institutions that are registered in China and capable of taking legal responsibilities independently. Overseas applicants should be lawful pharmaceutical companies. They should appoint corporate entities in China to act as their local agents for submitting the application….

Jan. 13th, 2023

2022 Global Cosmetic Animal Testing Regulation Updates Recap

Animal testing of cosmetics has always been a very hot and controversial topic. At present, nearly 40 countries and regions around the world have banned animal testing on cosmetics, including the United Kingdom, India, Israel, Australia and the European Union. China officially joined the ranks in May 2021, exempting general cosmetics from mandatory animal testing, thereby opening its market to foreign cruelty-free bands. However, meeting the prerequisites for China’s animal testing exemptions is challenging for some companies. We organized this webinar to help companies better cope with the current animal testing regulations in China and the rest of the world. In the webinar, Ms. Winnie Xu will first review the history of global animal testing regulations, then expound on the latest developments of China’s animal testing exemption regulations after more than 1 year of implementation and provide feasible paths for companies to enter the market circumventing animal testing. Finally, she…

Jan. 11th, 2023

A Look Back at 2022 with ChemLinked: Global Cosmetic Regulation Updates

In 2022, a great number of significant regulatory changes have taken place globally. China released and implemented a series of subsidiary regulations of Cosmetic Supervision and Administration Regulation (CSAR), further consolidating the new cosmetic regulatory framework. South Korea implemented the Cosmetic Safety Standards, specifying new prohibited and restricted ingredients. EU adopted important amendments to ingredient lists in Regulation (EC) No 1223/2009. Japan, ASEAN countries, Australia, US and Canada have also undergone several regulatory updates. Global cosmetic stakeholders need to stay vigilant about the regulatory changes, so as to effectively address compliance challenges, and aim for great success while shouldering their social responsibilities. Therefore, ChemLinked has prepared this webinar to provide an overview of the revised and emerging cosmetic regulations in the Asia-Pacific region, Europe and North America over the year, and help our clients analyze key regulatory points. Contents Session 1 Cosmetic Regulation Updates in China 1. Chinese Mainland 2. Taiwan, China Session…

Jan. 04th, 2023

A Look Back at 2022 with ChemLinked: Global Food Regulation Updates

The year 2022 witnessed many significant regulatory updates nationwide. In China, several significant food standards were released, such as the new GB standard for dairy products and food contact materials. South Korea has many critical regulatory revisions in 2022, regarding Food Code and labeling requirements. Japan also adopted new food additives and revised product standards in the past year. Global food stakeholders need to stay vigilant to cope with frequent regulatory changes, effectively address compliance challenges, and aim for great success while shouldering their social responsibilities. Therefore, ChemLinked has prepared this webinar to provide an overview of revised and emerging food regulations in global over the year and help our clients catch the key regulatory points. Contents Section 1 Food Regulation Updates in China 1. Import performance Import data of major food categories Analysis of import rejection 2. Regulations, GB standards and Drafts Unveiled in 2022 List of regulations and GB standards published/under consultation Interpretation…

Jan. 03rd, 2023

Latest Korea Chemical Regulation Updates and Implementation Status: K-REACH, K-BPR, and K-OSHA

REACH24H hosts its 14th Chemical Regulatory Annual Conference, free for all attendees to participate. Building on the success of the past two years of virtual forums, CRAC 2022 this year will focus on the status quo and future challenges and possibilities found in chemical management, pesticide registration, cosmetics, and food contact materials in Asia, the EU, the U.K., the U.S., and other major trade partners. CRAC 2022 – Global Chemical Compliance Management Session K-REACH Registration Status and Case Studies K-REACH concluded the registration of existing chemicals for 1,000 tonnage band tons by last year. This session will introduce the status of this registration, reports, and risk assessment of chemicals subject to registration. Accordingly, a risk assessment review is being conducted, and major revisions and precautions for future registration will also be covered. New MSDS Regulation Implementation Status This session will overview the changes in the MSDS system in Korea after the full revision of the Occupational Safety and Health Act on…

Dec. 27th, 2022

China Market Entry & Branding for OTC Products

In recent years, China has eased its market regulations when it comes to over-the-counter (OTC) medicines, allowing for the importation of OTC products through new channels such as cross-border E-commerce. This comes at a time when consumption of OTC products is growing, as Chinese consumers become more health conscious, providing new opportunities in the category. However, in order to ensure long-term success, OTC medicine brands need to understand the market, the category, and the consumers. Brands need to develop a market entry plan that considers both the sales channels available and the marketing strategies that will help the brand to reach the target consumers. During this webinar with Ryan Molloy, CEO of RedFern Digital, we will be discussing the China market entry options for foreign OTC drugs, before diving into aspects ranging from trends in the category and packaging and design, to changes in consumer demographics. We will provide viewers…

Dec. 16th, 2022
  • 문의하기
  • +82-02-6245-1610
  • korea@reach24h.com

TSCA Inventory Search Tool