Drugs - May 2017

  • Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP)

  • Australia: Guidelines on Code of Practice for Tamper-Evident Packaging of Therapeutic Goods

  • Brazil: Guidelines on Sets Up Requirements for the Implementation of the Brazilian Medicinal Products Control System

  • Brazil: Guidelines on Registry of Clinical Research Protocols in the Brazil Platform

  • China: Issuance of Four Guidelines for Consistency Assessment of Quality and Efficacy of Generic Drugs Such as Guidelines for Inspections on R&D Site

  • China: Technical Guidelines on Extrapolation of Adult Drug Data to Pediatric Population

  • Canada: Publication of Update to the Guidance Document: Data Protection Under C.08.004.1 of the Food and Drug Regulations

  • China: Soliciting Public Comment on Policies on Acceleration of Review and Approval of New Drugs and Medical Devices to Encourage the Innovation of Drugs and Medical Devices

  • China: Soliciting Public Comment on Policies on Reforming Administration of Clinical Trials to Encourage Innovation of Drugs and Medical Devices

  • China: CFDA Announcement Soliciting Public Comment on Policies on Implementing Life Cycle Management of Drugs and Medical Devices to Encourage Innovation of Drugs and Medical Devices

  • EU: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications

  • EU: Involving patients in discussions on benefits and risks of medicine; EMA publishes report on CHMP pilot project

  • EU: Guidelines on Chemistry of active substances (chemistry of new active substances)

  • USA: Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids

  • USA: 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation

  • USA: Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR); Delay of Effective Date

Click here for the full article on Global Regulatory Press.

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