Drugs - February 2018

February 12, 2018

  • International - WHO Drug Information, Volume 31, No. 4

  • International - EDQM Press Release: The Ph. Eur. Revised its General Chapters on Plasticised PVC Materials 

  • Australia - European Union Guidelines Adopted in Australia

  • Australia - Guideline: Australian Health Ministers’ Advisory Council: Scheduling Policy Framework for Medicines and Chemicals, Version 1.0

  • China - CFDA Announcement No. 2018/10: Adoption of International Conference on Harmonization (ICH) Guidelines on Technical Requirements for Registration of Pharmaceuticals for Human Use

  • China - CFDA Announcement No. 2018/16: Issuance of Technical Guidance for Phase I Clinical Trial Application of New Drug

  • India - CDSCO Letter No. X-11026/143/16-BD: Issuance of No Objection Certificate for Issuance of Form 29 License to Manufacture Drugs for Purposes of Examination, Test of Analysis for Biological Products (Vaccines & r-DNA Products)

  • Indonesia - Assembly and Submission of Applications: Electronic Submissions

  • Japan - Notification: PSEHB/PED No. 0118/1: ICH Guideline Topic E18 Step 4: Genomic Sampling and Management of Genomic Data

  • Japan - Notice: PSEHB/PED: Q&A on Implementation of Conditional Marketing Authorisation of Medicinal Products

  • Philippines - Marketing Authorization Procedures: Renewal    

  • South Korea - Presidential Decree No. 28589: Enforcement Decree of Narcotic Drug Control Act

  • Taiwan - MOWH Announcement No. 1061411970: Amendment to Drug Items Applicable to the Law: The Rare Disease and Orphan Drug Act

  • Thailand - FDA Notification: Drug List exempted from Government Fees

  • Canada - Notice: Adoption of International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: M7

  • Canada - Register of Innovative Drugs

  • European Union - EMA Press Release: EMA Surveys Pharma Companies on their Preparedness for Brexit

  • European Union - EMA Press Release: Human medicines: Highlights of 2017

  • United Kingdom - Marketing Authorization Procedures: Procedure for Unapproved Drug Use / Compassionate Use

  • United Kingdom - Authorities / Organizations: The Medicines and Healthcare products Regulatory Agency (MHRA) and The National Institute for health and Clinical Excellence (NICE)

  • Brazil - Resolution RDC 250: About the Renewal of Medicinal Product Registration, 20-Oct-2004 (Official Consolidated Version up to Amendments Brought by Resolution RDC 212 of 22-Jan-2018)

  • Gulf Cooperation Council - Circular No. 23-01-2018/0286: Acceptance of Bioequivalence Centers Owned by the Manufacturer,

  • Israel - Quality Assurance: Good Manufacturing Practice and Inspections

  • Saudi Arabia - Communication: Medical Equipment and Medicines Submitted to Value Added Tax at Zero Rate

  • USA - Guidance Bulletin: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

  • USA - Guidance Bulletin: Labeling for Combined Hormonal Contraceptives

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