Pharmacovigilance | Drug Safety | Safety Assessments | Regulatory Affairs

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

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

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

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

TGA: Labelling Changes, information for health professionals

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

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

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

CDER: New Drugs Regulatory Program Modernization

JAMA Study Reinforces FDA’s Call to Further Test Sunscreens

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

FDA to Study DTC Ads for Drugs Approved Under Accelerated Process

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

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

RWE Submissions: FDA Drafts Guidance

Clinical Lactation Studies: Considerations for Study Design Guidance for Industry

Post-approval Pregnancy Safety Studies Guidance for Industry

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

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

FDA: Considerations in Demonstrating Interchangeability with a Reference Product

Health Canada: Drafts Policies for Special Access to Medicines Program

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

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

FDA: OPQ Reports on State of Drug Quality in FY2018

European Commission Confirms Quality of South Korean Active Substances

FDA Unveils 34 New and Revised Product-Specific Draft Guidances

Reassessing Benefit-Risk: FDA Preps for New Guidance

WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

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

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

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

FDA: Considerations in Demonstrating Interchangeability with a Reference Product

UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

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

TGA Stops Sending Reminders About Device Annual Reporting Requirements

PH FDA QUALIFIES AS 5th ASEAN INSPECTION SERVICE

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

ICMRA: Drug Regulators Look to Harmonize How They Tackle Innovation

TÜV SÜD Becomes Second NB to be Designated Under EU MDR

EU Report Highlights Challenges of Regulating AI and Robotics in Healthcare

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

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

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

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

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

TGA: Labelling Changes, information for health professionals

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

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

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

CDER: New Drugs Regulatory Program Modernization

JAMA Study Reinforces FDA’s Call to Further Test Sunscreens

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

FDA to Study DTC Ads for Drugs Approved Under Accelerated Process

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

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

RWE Submissions: FDA Drafts Guidance

Clinical Lactation Studies: Considerations for Study Design Guidance for Industry

Post-approval Pregnancy Safety Studies Guidance for Industry

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

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

FDA Finalizes Maximal Usage Trials Guidance for Topical OTC Drugs

ICH: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES

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

MAPP Describes the Work of CDER’s Biopharmaceutics Council

FDA: Considerations in Demonstrating Interchangeability with a Reference Product

Health Canada: Drafts Policies for Special Access to Medicines Program

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

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

FDA: OPQ Reports on State of Drug Quality in FY2018

European Commission Confirms Quality of South Korean Active Substances

FDA Unveils 34 New and Revised Product-Specific Draft Guidances

Reassessing Benefit-Risk: FDA Preps for New Guidance

WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

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

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

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

FDA: Considerations in Demonstrating Interchangeability with a Reference Product

UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

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

TGA Stops Sending Reminders About Device Annual Reporting Requirements

PH FDA QUALIFIES AS 5th ASEAN INSPECTION SERVICE

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

ICMRA: Drug Regulators Look to Harmonize How They Tackle Innovation

TÜV SÜD Becomes Second NB to be Designated Under EU MDR

EU Report Highlights Challenges of Regulating AI and Robotics in Healthcare

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

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