NIAID ClinRegs – India

The NIAID ClinRegs website provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. ClinRegs also provides links to official regulations and other key resources related to international clinical research to facilitate independent analysis. Link… Continue reading

Apex Committee turns down DCGI’s proposal on trial approval for FDCs, subsequent new drugs, vaccines

Ramesh Shankar | PharmaBiz.com | Mumbai | 10 November 2014 The Union health ministry’s Apex Committee, headed by Union health secretary, has turned down a proposal by the Drugs Controller General of India (DCGI) to dispose of clinical trial proposals of new drugs already approved in other countries, fixed dose… Continue reading

China sets new requirements for hospitals running clinical trials

Zachary Brennan | 10 Nov 2014 The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. Read full article Also refer to:Free Treatment in Private Hospitals: Myth or Reality?Assessment of the Response of Public Hospitals in…Situational Assessment of Public… Continue reading

Clinical Trials Regulation: a step in the right direction?

The Lawyer | 23 April 2014 Read full article   Also refer to:The Myth of Regulation: A critique of the 2008 Draft…Participation in MoHFW meeting on Regulation and…Workshop on ‘Ethics and Regulation of Clinical…Workshop on Ethics and Regulation of Clinical Trials…Regulation of Drug Trials: A National ConsultationNational Consultation on Regulation… Continue reading

Guidelines for bioavailability and bioequivalence studies

Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi | March 2005 Read full article   Also refer to:Research Studies on Access to Medicines: Advisory MeetingsGuidelines not enough, enact surrogacy lawsMeeting with Delhi Govt. on implementation of MoHFW…Trials and… Continue reading