Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Law & Regulation CDE Guideline Marketing Approval Priority Review and Approval NRDL Health Insurance Rare Disease Drug Registration Real World DataThe 16th Rare Disease Day: China's Efforts to Make Orphan Drugs Available and Affordable This year’s Feb. 28 marks the 16th International Rare Disease Day. In China, there are around 20 million rare disease patients, with more than 200,000 additional patients each year. China has shown a supportive attitude towards rare disease drug development in a series of official documents. The regulations and policies introduced in this article are significant in terms of the drugs’ marketing authorization review timeline and pricing.
Mar 10, 2023
EDQM: Supplement 11.2 of the European Pharmacopoeia Available Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.
Mar 09, 2023
Pharmacopoeia MAH Marketing Approval CMC Clinical Trial Bioequivalence (BE) NRDL Drug Registration New Drug Real World Data PackagingMonthly Recap: China Pharmaceutical Regulatory Updates | February 2023 China's regulatory updates in Feb. 2023: 1. China NMPA Issues TCM Registration Rules; 2. China CDE Rolls Out Pharmaceutical Guidelines; 3. Chinese Pharmacopoeia Commission Issues Draft Standards
Mar 07, 2023
BaiPharm Regulatory Database Is Online: A Useful Tool to Search for China’s Pharma Guidelines, Regulations, and Standards ChemLinked BaiPharm Regulatory Database is a useful tool for ChemLinked users, especially overseas pharmaceutical companies that aim for China market, to search for China’s official guidelines, regulations, and Chinese Pharmacopoeia standards.
Feb 16, 2023
Law & Regulation CDE Guideline Pharmacopoeia Reference Listed Drug (RLD) Marketing Approval NRDL Drug Registration COVID-19 GLPMonthly Recap: China Pharmaceutical Regulatory Updates | January 2023 Check out the regulatory updates in Jan. 2023: 1. China Issues the 2022 National Reimbursement Drug List; 2. China Approves Two Homegrown Drugs for COVID-19; 3. China Releases Two Lists of RLDs; 4. China Issues GLP Certification Regulation; 5. China Rolls Out Pharmaceutical Guidelines; 6. Chinese Pharmacopoeia Commission Issues Drafts of Standards
Feb 06, 2023
Law & Regulation Pharmacovigilance Marketing Approval Volume-based Procurement Generic Drug Drug Registration E-commerce2022 Recap: Top 10 BaiPharm Stories on China Pharmaceutical Regulations ChemLinked BaiPharm Portal has been tracking and interpreting China’s pharmaceutical regulations during the year of 2022. Here are the top 10 stories we selected for you to grasp China’s regulatory dynamics.
Jan 13, 2023
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2022 Check out China's pharmaceutical regulatory updates in December 2022: 1. China NMPA Adds OTC Status to a Former Prescription Drug; 2. China NMPA Releases the 62nd List of RLDs; 3. China NMPA Issues Regulation on Supervising MAH as the Main Responsible Entity for Drug Safety; 4. China NMPA Requires Licenses for Importing and Exporting Anesthetics and Psychoactive Drugs; 5. China CDE Specifies Requirements for Electronic Submission of Drug Applications...
Jan 09, 2023
China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023 China NMPA requires that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper required, from Jan. 1, 2023.
Jan 01, 2023
Change Control for Transport of Medicinal Products Any change from design or predefined processes requires risk assessment and potential impact evaluation for both the transport process and, consequently, the product. This article discusses the importance of having a structured, compliant Change Control (CC) process in place for medicinal product manufacturers as well as for their qualified logistics vendors.
Dec 20, 2022
- [Updated] China Adds 111 Drugs to 2022 National Reimbursement Drug List
- [Updated] Drug Application Fees for FY 2023 in China and the U.S.
- Monthly Report: New Drug Approvals in China | January 2023
- Monthly Recap: China Pharmaceutical Regulatory Updates | January 2023
- [New Resource] China Marketing Authorization Holder (MAH)'s Responsibilities for Drug Quality