Regulatory Update – January 2020

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EC: Guidance on cybersecurity for medical devices

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Finland: Supervision of medical devices will be transferred from Valvira to Fimea

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FDA: Requesting FDA Feedback on Combination Products (draft guidance)

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FDA: Compliance Guide on Pre-approval Inspections for Drugs

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CDSCO: Additional time for medical device manufacturers to meet new regulations

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Philippine FDA included in ASEAN Mutual Recognition Agreement

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Guidance document for joining PIC/S

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WHO: Evaluation and publicly designation regulatory authorities as WHO listed authorities

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MEB fee rate change as of January 2020

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HPRA: Guide to Labels and Leaflets of Human Medicines

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BfArM – Hearing on sartan-containing medicines with regard to the avoidance of nitrosamine-containing impurities

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Swissmedic: New guidance document on Medicinal Product Names HMV4

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EMA: Q&A on the impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations

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MEB: Shorter timetable for a procedure for changing parallel package leaflet

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FDA: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions

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EC: The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED

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Swissmedic and the Korean regulatory authority extend their cooperation in the area of therapeutic products

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FDA: Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher

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EC: Note to the Pharmaceutical Committee updating on the actions undertaken about the quality of Active Pharmaceutical Ingredients

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FDA: Annual Reports for Approved Premarket Approval Applications (PMA)

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FDA: Paediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 (draft guidance)

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EMA: Mandatory use of the international standard for the reporting of side effects to improve the safety of medicines

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FDA: Process for Reviewing REMS Assessment Reports

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TGA: Fees and charges proposal 2020-21

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CDSCO: Update on fixed-dose combination drugs

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FDA: Reclassification of radiology devices

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EMA: Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

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EC: Notified body joint assessments

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Germany: Questionnaire for risk-based PV inspections

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EMA: Update on changing the name or address of a sponsor

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FDA: Update on cybersecurity

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FDA: Clinical Drug and In Vitro Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions

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EC: Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020

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FDA: Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment

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MHRA: Update on medical device clinical trial investigation and safety

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FDA: Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use – Premarket Notification (510(k)) Submissions (draft guidance)

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CDSCO: List of reference drugs for bioequivalence study

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Philippines FDA: Guidelines on medical device authorization

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FDA: Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

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EMA: Key principles for the use of electronic product information for EU medicines

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MHRA: Update on Withdrawal of notified body services

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FDA: FDA launches mobile-friendly database with information on life-saving HIV drugs as part of the ongoing mission to empower the public through increased access to information and data

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EMA: Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health

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UK: Changes to SPC and patent law from 1 January 2021

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FDA: New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2020

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EMA: UK withdrawal from the EU on 31 January 2020

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FDA: FDA revises generic drug application prioritization policy to ensure fairness to applicants, efficiently allocate limited agency resources, and protect the public health

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EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020

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