Posted by US FDA: CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions
Dissolution Testing: British Pharmacopoeia Responds to Consultation
US FDA: Draft Guidance – Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff
TGA Adds Permitted Indications to Complementary Medicine Guidelines
Health Canada – Mandatory use of eCTD
ICH Seeks to Harmonize Generic Drug Standards
Implementing the Falsified Medicines Directive: Safety Features
TGA: Reforms to the generic medicine market authorization process
EU: Targeted consultation on the guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another
US FDA: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements
CDSCO reaches consensus to roll out medical devices regulations in phased manner
Pharma SMEs seek rollback of mandatory submission of stability test for drug approval
Two additional countries to benefit from EU-US mutual recognition agreement for inspections
CDSCO urges medical device cos to register products by April 2020 in Sugam portal for timely approvals
MHRA Clarifies Medical Devices Policies for Users
TGA: Australia Proposes to Reclassify Spinal Implants in Line With EU MDR
Format and content for post-market drug benefit-risk assessment in Canada
India to Treat Implants and Imaging Equipment as Drugs From April 2020
US FDA: CDER Plots Established Conditions Pilot
HPRA-IMP expedited assessment of variations to Annex 3 and or 4 application form
Guide to Reporting and Initial Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use
Guidance for manufacturers of biological medicines – independent batch release in the United Kingdom following the UKs departure from the EU
TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda
Indonesia to postpone halal label deadline amid industry concerns
Health Canada – Notice to stakeholders Policy statement on the Naming of Biologic Drugs
EU measures in support of generic pharmaceuticals producers
US FDA programme to tighten food supplement regulatory standards may take toll on Indian nutraceutical exports