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Latest News | 23 April 2012

Korea, Japan Apply for PIC/S Membership

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The Korean Food and Drug Administration (KFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) have applied for membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the [Read More...]

Tags: drug Inspection Japan KFDA Korea Pharmaceutical PIC PIC/S PMDA Quality Scheme
Regulatory Update | 23 April 2012

China: Device Testing and Globalization of Trade

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China must gradually establish an international device regulatory philosophy to adapt strategy to the globalization of trade, according to SFDA Commissioner Yin Li, who spoke at the medical device [Read More...]

Tags: China Global Medical Device Regulation Regulatory SFDA
Regulatory Update | 23 April 2012

China: Healthcare Reform Opportunity To Strengthen Regulation

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The National Bureau of Policy and Regulation Department’s Liu Pei said on 12 April 2012 at a national food and drug regulation conference that health care reform provides an opportunity to strengthen [Read More...]

Tags: China drug Global Pharmaceutical Regulation SFDA
Regulatory Update | 23 April 2012

Brazil: House Holds Hearing on Breast Implants

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The Commission on Social Security and Family of the House of Representatives held on 19 April 2012 a public hearing to discuss the situation of Brazilian women with silicone breast implants made by [Read More...]

Tags: Anvisa Brazil Breast Implant Commission of Social Security and Family Medical Device PIP Rofil
Regulatory Update | 23 April 2012

Brazil: Advisory Council Discusses New ANVISA

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ANVISA’s Advisory Council—a group including representatives of the National Confederations of Industry (CNI), Commerce (CNC) and Health (CNS) and councils that represent the health secretaries of [Read More...]

Tags: 2012 Advisory Council Anvisa Brazil CNC CNI CNS Regulatory
Latest News | 23 April 2012

Hamburg: Nanotechnology Regulation Likely to Become ‘More Nuanced,' Outlines Regulatory Approach

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After releasing new nanotechnology standards for food and cosmetic products, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg says the agency’s approach to the regulation of [Read More...]

Tags: Benefit drug Guidance Hamburg Nanomedicine Nanotechnology Pharmaceutical Regulatory Risk Safety
Latest News | 23 April 2012

Electronic Submission Gateway Goes Live for Human Medicines Submissions, Announces EMA

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The European Medicines Agency (EMA) is announcing its eSubmission Gateway—the “electronic submission channel” for submitting electronic common technical documents (eCTDs) to EMA—is now up and running [Read More...]

Tags: Centralised Procedure Centralized Procedure CTD eCTD Electronic EMA eSubmission Gateway MAH submission
Latest News | 23 April 2012

Report: Internal FDA Report Slams European Regulation of Medical Devices as Ineffective

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The US Food and Drug Administration (FDA) has lambasted Europe's review process for medical devices in an unreleased internal report, claiming the failure of some devices to obtain FDA approval [Read More...]

Tags: CDRH Criticism Criticize EMA EU Europe FDA Maisel Medical Device medical devices report report Safety Shuren
Latest News | 23 April 2012

Woodcock: FDA Time, Resources Now Split Equally Between Premarket, Postmarket Analysis

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Janet Woodcock, Director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), told a meeting of healthcare journalists the agency is heavily invested in [Read More...]

Tags: AHCJ CDER drug FDA Mini-Sentinel Pharmaceutical Postmarketing Pre-marketing report Safety Sentinel Woodcock
Latest News | 23 April 2012

TGA Calls for Comments on Evidence Needed to Support Low-Risk Claims

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Australia’s Therapeutic Goods Administration (TGA) announced 23 April it is looking for comments on its draft guideline outlining the types of evidence needed to support indications made for low-risk [Read More...]

Tags: Australia Claims drug Indication Label Labeling Pharmaceutical Safety TGA
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