November 2022 | China Pharmaceutical Regulatory Updates

This is a collection of China’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities: National Medical Products Administration (NMPA); NMPA’s Center for Drug Evaluation (CDE); National Health Commission (NHC); National Healthcare Security Administration (NHSA); National Joint Drug Procurement Office; Chinese Pharmacopoeia (ChP) Commission. For more details about the summarized contents below, please send an enquiry to customer@reach24h.com. Contents 1. China NMPA Renews Classifications of Sodium Hyaluronate Products 2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks 3. China NMPA Consults on Chemical API Registration Renewal Regulation 4. China NMPA Announces Drug Banned from Online Sales 5. China NMPA Requires Online Drug Sellers and E-commerce Platforms to File Information 6. China NMPA to Enforce Drug Retail Delivery Regulations 7. China NMPA Consults on Drug MAH’s Main Responsibilities 8. China CDE Implements Work Procedures for Changes During Drug Review 9. China CDE Implements…

Dec. 14th, 2022

ANDA, NDA, BLA Registration and Registration Renewal in China

ANDA: abbreviated new drug application; NDA: new drug application; BLA: biologics license application Legal Basis of ANDA, NDA, BLA Registration and Registration Renewal 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) ANDA: Application for Market Approval of Generic Drugs Product Scope ANDA: generic drugs which are imported, sold, and used within the territory of the People’s Republic of China. Eligibility of Applicants Domestic applicants shall be an enterprise or drug development institution that can assume corresponding legal responsibilities. Overseas applicants shall be overseas pharmaceutical manufacturers with legal drug market approval. For overseas applicants, they must entrust a China business entity as the local agency. Application Procedure Domestic generic drugs, imported generic drugs Post-Marketing Obligation Change management, including major, medium, and minor-level…

Nov. 28th, 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

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

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

October 2022 | China Pharmaceutical Regulatory Updates

This is a collection of China’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities: National Medical Products Administration (NMPA); NMPA’s Center for Drug Evaluation (CDE); National Health Commission (NHC); National Healthcare Security Administration (NHSA); National Joint Drug Procurement Office; Chinese Pharmacopoeia (ChP) Commission. For more details about the summarized contents below, please send an enquiry to customer@reach24h.com. Contents 1. China NMPA Issues New Administrative Measures for Drug Recall 2. China NMPA Temporarily Extends Deadlines for Submitting Supplemental Documents 3. China NMPA Consults on GLP Certification Regulation 4. China NMPA Releases the 61th List of RLDs 5. China NMPA to Issue Electronic Certificates and Approval Documents 6. CDE Issues a Series of Guidelines and Rules 7. ChP Commission Seeks Public Advice on Drug Standards 1. China NMPA Issues New Administrative Measures for Drug Recall On Oct. 26, China NMPA issued the New Administrative Measures for Drug Recall, which took…

Nov. 09th, 2022

Cross-Border E-Commerce for OTC Drug

E-commerce market in China has become one of the most developed ones in the world, accordingly, the competition is fierce. Well-functioning ecosystem of online payment options and powerful mobile segment has made this market one of the important components of Chinese economy overall. As market trends are always changing, it is vital to take proper methods to create your competitive advantages and educate the consumers, thus generate ideal sale. BaiPharm has established our own online stores on Tmall Global and JD Worldwide, which are licensed to sell overseas OTC drugs to individual Chinese consumers. We would be delighted to try new and vigorous brands and products. Also, we can help overseas brands set up their own online stores in Tmall, JD, Tik Tok, and serve as a local agency for running the online business. Besides, we are open to supporting clients’ digital marketing campaigns. Our Services Local Agency Services Select…

Oct. 31st, 2022

China to Issue Electronic Drug Registration Certificates from November 2022

From Nov. 1, 2022, China National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as legally valid as the paper version. Electronic drug registration certificates will cover: Clinical trial approval certificate Marketing authorization certificate Re-registration certificate (for registration renewal) Supplemental application approval certificate Traditional Chinese medicine (TCM) protection certificate Imported raw ingredient certificate Certificate for active pharmaceutical ingredient (API) of chemical drug Good laboratory practice (GLP) certificate Marketing authorization holders (MAH) and drug applicants should sign up at NMPA\’s online service platform and confirm their real names, then check and download the electronic drug registration certificates. They can also log in to NMPA\’s mobile app \”中国药监\” to check the electronic certificates. Documents such as drug manufacturing process document, quality standard document, medication package insert, and label will not be included in electronic drug registration certificate itself. Instead, along with the electronic certificates, the attachments will be available in…

Oct. 31st, 2022

How to Sell OTC Drugs to China via Cross-Border E-Commerce (CBEC)

To market over-the-counter (OTC) drugs in China, stakeholders used to obey the same documentation requirements and marketing authorization application procedures as prescription drugs. *Please refer to the article to learn about OTC drug marketing authorization application procedures in China. In recent years, cross-border e-commerce has been developing as a different approach to enter China\’s OTC drug market. Cross-border e-commerce (CBEC) refers to selling goods on a third-party online CBEC platform from one country to individual consumers in another country. Contents China\’s OTC Drug Market Overview Differences Between CBEC and General Trade CBEC Positive List Three Delivery Modes for CBEC How to Establish an Online Drugstore on a Chinese CBEC Platform BaiPharm\’s CBEC Service for Overseas Medical Suppliers Related Webinar Webinar: How to Sell OTC Drugs to China via Cross-Border E-Commerce 1. China\’s OTC Drug Market Overview OTC drugs in the Chinese market mainly include cold drugs, cough drugs, pain relievers, gastrointestinal…

Oct. 14th, 2022
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