Regulatory Update – September 2019

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China’s NMPA releases new UDI guideline (article in Chinese)

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India’s NPPA clarifies knee implant price caps amid market confusion

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CDSCO has postponed fixed-dose combination (FDC) deadline

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Further guidance notes on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

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FDA in Brief: FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound drugs using nine bulk drug substances

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Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers

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Amendments to the list of bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act

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HPRA: Extension of FMD Use and Learn Period Ireland beyond September 2019

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 HPRA:  Marketing authorization holders – Brexit regulatory and supply preparedness – Human Medicines

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Drugs for treatment of partial-onset seizures: Full extrapolation of efficacy from adults to pediatric patients 2 years of age and older

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FDA: Humanitarian Device Exemption (HDE) Program

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FDA: Electronic Submissions; Data Standards; Support for Unified Code for Units of Measure

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FDA: Acceptance review for De Novo classification requests

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FDA: FDA and industry actions on De Novo classification requests: Effect on FDA review clock and goals

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FDA: User fees and refunds for De Novo classification requests

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TGA: Proposed changes to the medical device essential principles for safety and performance

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Novartis Inhaler is the first device to be certified under MDR

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EC explains new MDR, IVDR rules for designating expert device panels

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EC: Guideline on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties

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FDA: The Special 510(k) Program

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FDA: The Abbreviated 510(k) Program

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FDA: Refuse to Accept Policy for 510(k)s

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FDA: Format for Traditional and Abbreviated 510(k)s

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EMA: Preparedness of medicines’ clinical trials in pediatrics Recommendations by the Enpr-EMA working group on trial preparedness

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FDA: Product-Specific Guidance for Generic Drug Development

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MHRA: Public update: 2019, Strategy for pharmacopoeial public quality standards for biological medicines

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HSA Stops Supply of Eight Brands of Ranitidine Products in Singapore

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 TGA: N-nitroso compounds in sartan blood pressure medicines

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 TGA: Consultation: Products used for and by people with disabilities Options for amendment to the Therapeutic Goods (Excluded Goods) Determination 2018

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TGA: Fee-free period for sponsors to transition existing listed medicines to permitted indications has been extended

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FDA: Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings

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 MHRA: Brexit update – What a UK Responsible Person is

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 FDA: Safer Technologies Program for 3 Medical Devices – Draft guidance

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HPRA: Brexit regulatory and supply preparedness – Medical Devices

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FDA: Framework for the Safety and Performance Based Pathway

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Biotronik first to land MDR certification for a high-risk device

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 FDA: Patient Engagement in the Design and 2 Conduct of Medical Device Clinical 3 Investigations

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 FDA: Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020

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FDA: Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (draft guidance)

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TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

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FDA: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

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MHRA: Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit

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