Regulatory Updates- Feb 2019

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US FDA: CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions

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Dissolution Testing: British Pharmacopoeia Responds to Consultation

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US FDA:  Draft Guidance –  Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff

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TGA Adds Permitted Indications to Complementary Medicine Guidelines

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Health Canada – Mandatory use of eCTD

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ICH Seeks to Harmonize Generic Drug Standards

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Implementing the Falsified Medicines Directive: Safety Features

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TGA: Reforms to the generic medicine market authorization process

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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

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US FDA:  Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements

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CDSCO reaches consensus to roll out medical devices regulations in phased manner

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Pharma SMEs seek rollback of mandatory submission of stability test for drug approval

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Two additional countries to benefit from EU-US mutual recognition agreement for inspections

https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections

CDSCO urges medical device cos to register products by April 2020 in Sugam portal for timely approvals

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MHRA Clarifies Medical Devices Policies for Users

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TGA: Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

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Format and content for post-market drug benefit-risk assessment in Canada

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India to Treat Implants and Imaging Equipment as Drugs From April 2020

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US FDA: CDER Plots Established Conditions Pilot

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HPRA-IMP expedited assessment of variations to Annex 3 and or 4 application form

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Guide to Reporting and Initial Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use

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Guidance for manufacturers of biological medicines – independent batch release in the United Kingdom following the UKs departure from the EU

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TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda

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Indonesia to postpone halal label deadline amid industry concerns

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Health Canada – Notice to stakeholders Policy statement on the Naming of Biologic Drugs

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EU measures in support of generic pharmaceuticals producers

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US FDA programme to tighten food supplement regulatory standards may take toll on Indian nutraceutical exports

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