Updates on Drugs - April 2017

  • Australia: Strengthening Monitoring of Medicines in Australia

  • Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs

  • Canada: Notice: Guidance Document - Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales

  • Canada: Upcoming Changes to the Annual Drug Notification Form

  • China: Announcement on List of Reference Products for Generics (1st Batch)

  • China: Announcement on List of Reference Products for Generics (2nd Batch)

  • China: Soliciting Public Comment on the Decision Regarding Matters Related to Drug Import Registration Management (Draft)

  • China: Attachment of Guideline - Chinese Good Manufacturing Practice (GMP) for Biochemical Drugs

  • EU: Template for Notification of Change of the Paediatric-Investigation-Plan / Waiver Applicant / Addressee

  • EU: Concept Paper on Revision of the Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, Draft: Consultation Open

  • EU: Concept Paper on Revision of the Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for the Treatment of Asthma in Children and Adolescents., Draft: Consultation Open

  • EU: The New EudraVigilance System and the Electronic Reporting of the Individual Case Safety in the ISO/ICH E2B(R3) Format: Hands-On Training Course, European Medicines Agency, London, UK

  • EU: Report to the European Parliament and the Council on the Summary of Product Characteristics and the Package Leaflets

  • EU: European Medicines Agency Practical Guidance on the Application Form for Centralised Type IA and IB Variations

  • EU: Rules for the Implementation of Council Registration (EC) No 297/95 on Fees Payable to the European Medicines Agency and Other Measures - Revised Implementing Rules to the Fee Registration as of 1 April 2017, Adopted

  • EU: Applications for New Human Medicines Under Evaluation by the CHMP: March 2017

  • Japan: Standard Operation Procedure of Regulatory Science Comprehensive Consulting for Medicinal Products, Medical Devices and Regenerative Medical Products

  • Japan: No. 341 Pharmaceuticals and Medical Devices Safety Information (PMDSI)

  • Japan: Compliance with Regulations of Post-Marketing Safety Management for Marketing Authorisation Holder

  • Japan: Revisions of Fees Payable to Pharmaceuticals and Medical Devices Agency for Product Review of Pharmaceuticals and Medical Devices (Applicable From April 1, 2017)

  • Japan: ICH Guideline Topic E2B(R3) Step 4: Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Data Elements and Message Specification, Version 5.02

  • Taiwan: TFDA Consultation Window for Medicinal Products Q&A (2017)

  • Turkey: To All Stakeholders - Inappropriate Use of the Status Enquiry Service

  • US: Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II

  • US: FDA Warns About Increased Risk of Pancreatitis with Irritable Bowel Drug Viberzi (Eluxadoline) in Patients Without a Gallbladder

  • US: Product-Specific Guidances for Rifaximin

  • US: Considerations in Demonstrating Interchangeability With a Reference Product; Comment Extension


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