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
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