Internationalpharmaceuticalregulatorymonitor

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January 2018

Vol. 46
No. 1

Headlines

EMA Adopts ICH Guideline on Multi-Region Clinical Trials

The European Medicines Agency adopted the International Council for Harmonization E7 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more efficient drug development. Read More

FDA and CTTI Launch Patient Forum to Boost Engagement in Drug Development

The Patient Engagement Collaborative is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between the FDA and Duke University. Read More

EMA to Juggle Brexit and New Quality and Safety Guidelines

The European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines this year, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More

EMA Updates Brexit Guidance With Info for Generics Manufacturers

The European Medicines Agency and the European Commission broadened their guidance on Brexit to include new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on reference product data as well as new clinical trial findings. Read More

International Drugmakers Plan for Higher Costs as Brexit Looms

Testifying before a UK House of Commons committee last month, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making preparations for new hurdles in manufacturing and duplications of batch release testing that could cost millions of pounds per year. Read More

TGA Issues New Criteria for Comparable Overseas Regulators

Australia’s Therapeutic Goods Administration issued revised guidelines for its comparable overseas regulators (CORs) program, designed to collaboratively regulate prescription medicines using an international report-based process. Read More

Senate Committee Grills Azar on Eli Lilly Price Hikes

Alex Azar, President Trump’s nominee for Secretary of Health and Human Services, emphasized his view that “drug prices are too high” to the Senate Finance Committee, even as Democrats continued to ask about his role in drug cost increases at Eli Lilly when he served as its president. Read More

EEA Third-Country GMP Inspections Drop by 25 Percent in 2016

Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of non-compliance over the same time period. Read More

EMA’s PRAC Revises Methods for Measuring Pharmacovigilance Impacts

The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful. Read More

Quality System Issues Dominate MHRA’s GDP Report

Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Read More

EMA’s CHMP Recommends Seven Medicines for Approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy. Read More

China FDA to Require Registration, Training of Medical Reps

China FDA released draft regulations that would require medical representatives in China to register, and mandate that medical product marketing authorization holders provide adequate training. Read More

ANSM Creates New Unit to Handle Early Stage Clinical Trials

France’s Agency for the Safety of Health Products has established a unit dedicated to overseeing early phase clinical trials. Read More