Drug - Dec 2018

  • Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018

  • Brazil - Questions and Answers: Resolution RDC 242/2018 on Registration of Specific Medicinal Products

  • Canada - Form: Post-Notice of Compliance Changes: Level III

  • China - NMPA Notification No.GuoYaoJianYaoGuan 2018/43: Issuance of Regulation on Administration of Export Certificates of Pharmaceutical Products, 09-Nov-2018 (English and Chinese Versions)

  • Germany - PEI: Information on Clinical Trials in Germany and Europe now Publicly Available

  • India - Notice No. CDSCO/IT/2018-(22): Uploading Data of Drug Manufacturing Facilities and Approved Drug Formulations on SUGAM Portal-Guidelines Issued

  • Japan - Notification: PSEHB/PED No. 0927/3: Matters to Consider in Safety and Evaluation of the Quality of Oligonucleotide Therapeutics

  • Saudi Arabia - Draft Requirements for the Unique Device Identification System

  • Taiwan - TFDA Notification: List of Drug Material File (DMF)

  • United Kingdom - Clinical Research: Initiation and Conduct of Clinical Trials

  • USA - Federal Register: Definition of the Term "Biological Product" - 21 CFR Part 600 (Proposed rule)

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