Drugs - May 2018

May 23, 2018

  • International - Press Release of the PIC/S Committee Meeting in Geneva (Switzerland), May-2018 

  • Australia - Australian Regulatory Guidelines for Complementary Medicines (ARGCM)

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

  • Japan - PMDA/AREDPG No. 0517001: Revision of Technical Conformance Guide on Electronic Study Data Submissions

  • Canada - Consultation for Mandatory Requirements of using Electronic Common Technical Document (eCTD) Format when Submitting Master Files (MFs)

  • European Union - CMDh/373/2018, Rev.0: Practical Guidance for Procedures Related to Brexit for Medicinal Products for Human Use Approved Via MRP/DCP

  • European Union - EMA/191104/2015: European Medicines Agency Guidance for Applicants Seeking Access to PRIME Scheme

  • United Kingdom - MHRA: Guidance for the Notification of Serious Breaches of Good Clinical Practice or the Trial Protocol

  • United Kingdom - SI 2018 No.345: The Branded Health Service Medicines (Costs) Regulations 2018, 08-Mar-2018 (and its Correction) 

  • Brazil - Dissolution Methods Applicable to New, Generic and Similar Medicinal Products

  • Gulf Cooperation Council - GHC Circular 1837: Cancellation of Registered Products With Expiring Central Registration

  • Saudi Arabia - Sanctions Applicable to Manufacturers or their Authorized Representatives for Not Reporting Field Actions on Medical Products and Devices

  • USA - Federal Register Amendment: Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal (Direct final rule; withdrawal)

  • USA - Draft Guidance for Industry: Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, May-2018 

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