USA: HHS Looks to Overhaul the Common Rule (SEP-2015)

This week the HHS released a Notice of Proposed Rule Making (NPRM).  This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. The […]

Continue Reading

EU: EMA Monitoring of ADRs in Medical Literature Goes Live (SEP-2015)

The European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the EudraVigilance database.  The service is fully operational as of 1 September 2015. Scientific and medical literature is an […]

Continue Reading

EU: Drug Consumption Databases in Europe

The inventory of Drug Consumption Databases in Europe is a comprehensive and structured source of information on drug consumption in Europe. It comprises two documents. The master document contains a detailed report of the available information, methods to retrieve this information, a description of the validity of national drug consumption data and a discussion. The […]

Continue Reading

India: Updates to India’s Drugs and Cosmetics Rules (AUG 2015)

ClinRegs has updated its regulatory information for India to reflect changes described in the 5th and 6th Amendments to India’s Drugs and Cosmetics Rules, which took effect in summer 2015. Salient changes include: Initial investigator reporting timeline is now 24 hours for all Serious Adverse Events (SAEs) and not just serious and unexpected adverse events Reporting timeline for SAEs has changed from 10 […]

Continue Reading

EU: ENCePP Guide on Methodological Standards in Pharmacoepidemiology – Revision 4 (July 2015)

ENCePP have released Revision 4, dated July 2015, with a revision or update of most chapters of the ‘Guide on Methodological Standards in Pharmacoepidemiology. The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological English language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, […]

Continue Reading

ICH GCP Addendum Released for Public Consultation (Aug 2015)

An addendum to ICH GCP has been released for public consultation. WC500191488 (ADDENDUM highlighted)[1] copy To complement the harmonised ICH E6 Guideline, which was finalised in May 1996, this Addendum is proposed to modernise ICH E6 to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure […]

Continue Reading