Study quantifies drug revenue invested in R&D

International – Study quantifies drug revenue invested in R&D

A coalition of the drug industry’s fiercest foes is accusing the world’s top drug makers of hiding behind research and development “as an excuse...
WHO: More countries adopting plans to reduce hepatitis C rates

International – WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

The World Health Organization (WHO) issued a draft document Wednesday on environmental aspects of good manufacturing practices (GMP) to aid inspectors and manufacturers of...
Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

International – Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

This article discusses the scope and purpose of the special designation for Regenerative Medicine Advanced Therapies (RMAT) created by the passage of the 21st Century Cures...
ICH Drafts Revised Guideline on General Considerations for Clinical Studies

International – ICH Drafts Revised Guideline on General Considerations for Clinical Studies

With a focus on modernization, the International Council for Harmonisation (ICH) on Thursday released for public consultation a draft version of its guideline E8(R1)...
Two additional countries to benefit from EU-US mutual recognition agreement for inspections

International – Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a...
WHO: More countries adopting plans to reduce hepatitis C rates

International – WHO Seeks Consultant to Help Cambodia Strengthen Drug Regulation

The World Health Organization (WHO) is recruiting a consultant to help Cambodia improve its drug regulatory system. WHO will task the short-term consultant with...
ICH Updates: What’s Coming in 2019 and Beyond

International – ICH Updates: What’s Coming in 2019 and Beyond

US Food and Drug Administration (FDA) officials on Monday morning held a meeting to offer a rundown of what needs to be done and...
ICH Updates: What’s Coming in 2019 and Beyond

International – Guideline : General Principles for Planning and Design of Multi-Regional Clinical Trials...

Objectives of the Guideline With the increasing globalisation of drug development, it has become important that data from multi-regional clinical trials (MRCTs) can be accepted by...
EU files WTO dispute with Turkey over pharma laws

International – EU files WTO dispute with Turkey over pharma laws

According to Commissioner for Trade Cecilia Malmström, Turkey is effectively forcing manufacturers of pharmaceuticals to move production into the country if they want their...
Big Pharma come together for better drug side effect detection

International – Big Pharma come together for better drug side effect detection

The Drug Safety Research Unit (DSRU) established the international group that consists of pharma giants such as Pfizer, Roche, BMS, Takeda, Lilly, Gilead, Alexion...

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