Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022 Check out the pharma regulatory updates in China: The 7th National Volume-based Procurement (VBP) Includes 327 Drug Products; China CDE Consults on Procedures for Starting For-cause Inspections; China CDE Releases Q&A on Immediate Report of Adverse Drug Reactions in Clinical Trials...
Aug 05, 2022
The Turkish Pharmaceutical Industry's Regulatory Landscape This article introduces the general organizational and regulatory landscape of the pharmaceutical industry in Turkey in terms of licensing, advertising and promotion, pricing & reimbursement, data privacy, and competition.
Aug 03, 2022
Chinese Pharmacopoeia Commission Seeks Public Advice on Colorant Standards The Chinese Pharmacopoeia Commission is currently asking for public advice on colorant standards. The target colorants include but are not limited to colorants used in pediatric drugs, or widely used in pharmaceuticals, or whose current quality control standards are incomplete, especially for operation, and whose current standards cannot meet the need for medical use.
Jul 18, 2022
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022 Check out the pharmaceutical regulatory updates in China: 1.CDE Issues the 2021 China Drug Evaluation Report; 2. CDE Publishes the 2021 Clinical Trial Report; 3. CDE Consults on Communication Procedures for Pediatric Drug Applicants...
Jul 06, 2022
China Implements GMP Appendix for Investigational Products Used in Clinical Trials On July 1, 2022, the Appendix to GMP for Pharmaceuticals: Investigational Products Used in Clinical Trials comes into effect. The Appendix is a supporting document for China's pharmaceutical GMP, which was revised in 2010 and has been effective since 2011.
Jul 01, 2022
European Commission Publishes Draft on Labeling Requirements for IMPs With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.
Jun 22, 2022
EMA Issues New Guidance Documents for GCP Inspections Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.
Jun 22, 2022
Law & Regulation Reference Listed Drug (RLD) Marketing Approval Bioequivalence (BE) Drug RegistrationCPhI & BaiPharm Event: Generic Drug Application Procedures in China On June 22, BaiPharm is going to co-organize a webinar with CPhI China on the topic of Generic Drug Application Procedures in China.
Jun 21, 2022
- 2021 China CDE Drug Evaluation Report
- Monthly Report: New Drug Approvals in China | June 2022
- China Kicks off the 7th Round of Volume-based Procurement (VBP) of Drugs
- China Emphasizes Rare Disease & Pediatric Drugs in Adjusting the 2022 National Reimbursement Drug List (NRDL)
- Licensing Deals Involving Chinese Pharma Companies in H1 2022