Regulatory Update – May 2019

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WHO:  No Time to Wait: Securing the future from drug-resistant infections

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US FDA and Health Canada Joint Regional Consultation on the International Council for Harmonisation (ICH)

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CDSCO: Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials

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CDE Shares Chinese Medicine Clinical Research Guidelines for Consultation (article in Chinese)

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TGA:  Labelling Changes, information for health professionals

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

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EMA: Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 30 April 2019

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Health Canada: Supporting evidence for implantable medical devices manufactured by 3D printing

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CDER: New Drugs Regulatory Program Modernization

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JAMA Study Reinforces FDA’s Call to Further Test Sunscreens

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China Reviews Supervision of Cell and Gene Therapies Through Regulatory Action Plan (article in Chinese)

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FDA to Study DTC Ads for Drugs Approved Under Accelerated Process

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FDA Finalizes Two Guidance’s to Align X-Ray Imaging Devices With International Standards

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List Prices in Drug Ads on TV Coming as CMS Finalizes Rule

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RWE Submissions: FDA Drafts Guidance

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Clinical Lactation Studies: Considerations for Study Design Guidance for Industry

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Post-approval Pregnancy Safety Studies Guidance for Industry

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France’s ANSM Addresses Cell and Gene Therapies in Revisions to GMP Guide (article in French)

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Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labelling Recommendations Guidance for Industry

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FDA Finalizes Maximal Usage Trials Guidance for Topical OTC Drugs

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ICH: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES

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FDA: Determining Whether to Submit an ANDA or a 505(b)(2) Application

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MAPP Describes the Work of CDER’s Biopharmaceutics Council

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FDA: Considerations in Demonstrating Interchangeability with a Reference Product

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Health Canada: Drafts Policies for Special Access to Medicines Program

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Study Finds Few Voluntary Post-approval Trials for First Approved Indication

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China’s Drug Regulator Tightens Ties to Agencies in Hong Kong and Macau (article in Chinese)

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FDA: OPQ Reports on State of Drug Quality in FY2018

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European Commission Confirms Quality of South Korean Active Substances

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FDA Unveils 34 New and Revised Product-Specific Draft Guidances

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Reassessing Benefit-Risk: FDA Preps for New Guidance

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WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

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Health Canada: Final report, fees for Drugs and Medical Devices

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Health Canada: Performance Standards for the fees in respect of drugs and medical devices order

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FDA: Patient Use of Unapproved Diabetes Management Devices Poses Insulin Dosing Risks

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FDA: Considerations in Demonstrating Interchangeability with a Reference Product

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UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

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CDSCO India Assigns Risk Categories to Imaging Scanners, Other Recategorized Devices

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TGA Stops Sending Reminders About Device Annual Reporting Requirements

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PH FDA QUALIFIES AS 5th ASEAN INSPECTION SERVICE

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US FDA: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations

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ICMRA: Drug Regulators Look to Harmonize How They Tackle Innovation

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TÜV SÜD Becomes Second NB to be Designated Under EU MDR

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 EU Report Highlights Challenges of Regulating AI and Robotics in Healthcare

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HPRA:  Guide to New applications and variations to Manufacturer’s Authorisations

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