Posted by FDA: Promotional Labelling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers (Draft guidance)
Philippines FDA: Guidelines on the classification of deficiencies observed during inspection of drug manufacturers
CDSCO: processing of post-approval changes to bioavailability and bioequivalence (BA/BE) studies
CDSCO: Rules relaxed for imported medicines labelling requirement
EC: Norway’s DNV GL is the 10th NB under MDR
FDA: NGS HIV Drug Resistance Test Into Class II
FDA: Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed (draft guidance)
TGA: Microbiological quality of medicinal cannabis products
Malaysia: Notification of refurbished medical device
TGA: Warning about products claiming to treat or prevent the novel coronavirus
CDSCO: Deadline extended for FDC application
EMA: ICH M9 on biopharmaceutics classification system based biowaivers
UK: New medicine, medical device bills introduced post Brexit
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad
UK MHRA: Applying for a licence during the transition period
EMA: ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals
EMA: ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
CDSCO: Update on medical device regulation
CDSCO: Update on drug product quality responsibility
TGA: Meeting the evidence requirements for market authorisation
TGA: Guidance for TGO 101(Standard for tablets, capsules and pills)
FDA: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics (Draft guidance)
Health Canada: Implementation of eCTD for clinical trial regulatory activities
FDA: Definition of the Term “Biological Product”
FDA: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
FDA: Purple book, database of licensed biological products
TGA: Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
CDSCO: Clarification on new drug, clinical trial and BA/BE applications
TGA: Outcomes: Changes to permissible ingredients – Low-negligible risk
TGA: Medical device application processing times
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
FDA: FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications
Swiss medic: Swiss medic authorises a new active substance (NAS) under the ACSS Consortium initiative for the first time
EU: Changes proposed in sterile product manufacturing
EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020