Drugs - August 2017

  • US: FDA and Beyond – REMS 1.16 Subheading Instructions for eCTD M1 v2.3 (DTD 3.3)

  • US: Manual of Policies and Procedures(MAPP) 6021.1 NDAs/BLAs: Financial Disclosure

  • US: Manual of Policies and Procedures (MAPP) 5210.4 Rev.2 Review of Bioequivalence Studies with Clinical Endpoints in ANDAs

  • Canada: Implementation of Regulated Product Submission (RPS) and Electronic Common Technical Document Version 4 (eCTD v4)

  • Canada: Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

  • Argentina: Circular 4/2017: Forms to Obtain Authorization to Import/Export Biological Samples for Clinical Trials

  • Argentina: ANMAT-MED-BIO 006-00: Sets Up Requirements for the Production and Registration of Advanced Therapy Medicinal Products

  • EU: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

  • EU: Telematics- New versions of the 4 electronic Application Forms (eAF v. 1.21)

  • EU: Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when

  • Russia: Ministerial Order N 706 of 14-Jun-2017: On Approval of the Rules for Destruction of Falsified, Substandard and Counterfeit Biomedical Cell Products

  • Russia: Roszdravnadzor Information Letter N 01I-1420/17 of 14-Jun-2017: On New Legislative Requirements for Pharmacovigilance

  • Australia: Notification of a New Proprietary Ingredient

  • Australia: GMP Clearance Process – Fees for Compliance Verification GMP Clearance Applications

  • Japan: Safety Information of Product: No. 344 Pharmaceuticals and Medical Devices Safety Information (PMDSI)

  • Japan: Notification – PSEHB No. 0626/3: Reminder for Roles of General Marketing Compliance Officer/Quality Assurance Manager/Safety Control Manager in the Responsibilities of the Marketing Authorisation Holder of Pharmaceutical Products

  • Japan: Notice – PSEHB/PED: Q&A on Administrative Guidance for the Approval Application of Chinese Medicine (Kanpo-Yaku) Approved by Prefectural Governor

  • Japan: Notification – PSEHB/PED No. 0609/8, PSEHB/SD No. 0609/4: Basic Concept for the Use of Medical Information Database Regarding Pharmacovigilance Planning

  • Japan: Notice – PSEHB/SD: Q&A on Reporting of Adverse Drug Reactions of Combination Products, Revision

  • Japan: Notice – PSEHB/SD: Initiative Guideline of Marking for References of Risk Management Plan Prepared and Distributed to Minimise the Risk in Additional Activities

  • China: CFDA Announcements No.190: Announcement on Results of Classification for the Third Batch of Combined Products of Drugs and Medical Devices

  • India: Guidelines- Notice F. No. D.21013/76/2017 -DC: Streaming the Regulatory Procedures by Relaxing and Modifying the Existing Provisions of the Drugs and Cosmetics Rules

  • India: NPPA Office Memorandum F. No.19(1064)/2016/DP/Div.II/NPPA: Impact of GST on Pharmaceutical Pricing

Click here for the full article on Global Regulatory Press.

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