Regulatory Update – Feb 2020

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FDA:  Promotional Labelling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers (Draft guidance)

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Philippines FDA: Guidelines on the classification of deficiencies observed during inspection of drug manufacturers

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CDSCO: processing of post-approval changes to bioavailability and bioequivalence (BA/BE) studies

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CDSCO: Rules relaxed for imported medicines labelling requirement

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EC: Norway’s DNV GL is the 10th NB under MDR

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FDA:  NGS HIV Drug Resistance Test Into Class II

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FDA: Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed (draft guidance)

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TGA: Microbiological quality of medicinal cannabis products

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Malaysia: Notification of refurbished medical device

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TGA: Warning about products claiming to treat or prevent the novel coronavirus

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CDSCO: Deadline extended for FDC application

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EMA: ICH M9 on biopharmaceutics classification system based biowaivers

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UK: New medicine, medical device bills introduced post Brexit

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)

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FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

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UK MHRA: Applying for a licence during the transition period

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EMA: ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals

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EMA: ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

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CDSCO: Update on medical device regulation

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CDSCO: Update on drug product quality responsibility

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TGA: Meeting the evidence requirements for market authorisation

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TGA: Guidance for TGO 101(Standard for tablets, capsules and pills)

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FDA: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics (Draft guidance)

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Health Canada: Implementation of eCTD for clinical trial regulatory activities

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FDA: Definition of the Term “Biological Product”

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FDA: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

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FDA: Purple book, database of licensed biological products

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TGA: Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

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CDSCO: Clarification on new drug, clinical trial and BA/BE applications

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TGA: Outcomes: Changes to permissible ingredients – Low-negligible risk

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TGA: Medical device application processing times

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FDA: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices and Recommendations for Dual 510(k) and CLIA Waiver by Application Studies

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FDA: FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications

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Swiss medic: Swiss medic authorises a new active substance (NAS) under the ACSS Consortium initiative for the first time

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EU: Changes proposed in sterile product manufacturing

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EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020

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