top of page
  • Writer's pictureARQon

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)

Contact us at info@arqon.com.


25 views0 comments

Recent Posts

See All

Asia, Africa, Middle East - Jan/Feb 2020

Australia: Fees and charges proposed for 2020–2021 Australia: Regulatory changes for software, personalised medical devices and IVD companion diagnostics, and reclassification of certain devices Austr

Taiwan Cybersecurity Requirements Update

Taiwan Cybersecurity Requirements Update On 21st November, the Taiwan Food and Drug Administration (TFDA) published the "Medical Device Cybersecurity Framework for Manufacturer". The TFDA issued the d

bottom of page