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MHRA updates on the new PV legislation
MHRA informed today that by July 2012, the new pharmacovigilance legislation come into effect across the EU as a result of changes set out in:
Regulation (EU) No1235/2010 (external link)
Directive 2010/84/EU (external link)
The changes introduced by the Directive will be transposed into UK law in the Human Medicines Regulations 2012, which also consolidate nearly all other UK medicines legislation.
The legislation will be underpinned by an EC Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice (see below).
ICH E2C(R2) reaches Step 2 of the ICH Process
The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 2 of the ICH Process in February 2012 and now enters the consultation period (Step 3).
The purpose of therevised guidance is to ensure that the periodic safety update reports for marketed drugs have the role of being periodic benefit-risk evaluation reports by covering: Safety evaluation, evaluation of all relevant available information accessible to marketing authorisation holders (MAHs) and benefit-risk evaluation.
This Step 2 document marks the conclusion of the first phase of the E2C(R2) Expert Working Group’s mandate. During the consultation period, the group will initiate the second phase of its mandate which is to conduct a gap and potential improvement analysis of ICH E2C, E2E and E2F Guidelines.
The Step 2 consultation version can be downloaded here
Access to ICH Efficacy guidelines here
FDA issues a warning letter to MSD
The FDA has given warning letter to MSD for marketing a misbranded product (Januvia and Janumet). FDA claim that Merck has failed to conduct agreed upon post marking studies. The Warning Letter describes a long history of back and forth discussions in the warning letter.
FDA issues two drug safety draft guidances
March 8th 2012 FDA issued two draft guidances related to drug safety:
1 - Drug Safety Information – FDA’s Communication to the Public
2 - Clarifying Significant Postmarketing Drug Safety Issues
The guidance "Clarifying Significant Postmarketing Drug Safety Issues" is the most important guidance where FDA proposes a classification of significant drug safety issues into three categories: priority, standard, or emergency. FDA notes that the classification system is being put in place in order to have a common understanding across all offices in the Center for Drug Evaluation & Research and to prioritize attention to issues that need to be addressed the fastest. FDA will implement the new framework within a year.
FDA report experience with use of Electronic Health Records in signal detection
The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which represented the FDA’s first experience with the receipt of electronic health record (EHR)– triggered adverse event reports. The EHR-triggered adverse event reports from ASTER were evaluated for their utility in conducting FDA’s pharmacovigilance work. FDA is sharing these findings to assist others who are pursuing the use of patient EHR data for electronic adverse event identification and reporting.
