Internationalpharmaceuticalregulatorymonitor

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October 2017

Vol. 45
No. 10

Headlines

EMA Updates 18-Year-Old Guidelines for Cardiovascular Clinical Trials

The European Medicines Agency updated two guidelines on clinical trials for cardiovascular treatments in acute coronary syndrome and chronic heart failure, first adopted in 2000. Both guidelines are scheduled to take effect March 1, 2018. Read More

FDA Goal to Bring Puerto Rican Drug Manufacturing Back Online, Gottlieb Says

Following the destruction by Hurricane Maria in Puerto Rico, FDA Commissioner Scott Gottlieb said one of the agency’s main goals in the recovery effort is to bring the island’s medical product manufacturing plants back into operation. Read More

FDA Officials Highlight Compliance and Warning Letter Trends

CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More

CHMP Recommends First Herceptin Biosimilar, 12 Other Medicines

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended thirteen products, including its first biosimilar for Genentech’s blockbuster drug Herceptin. Read More

UK Firms May Have Trouble Lifting GMP Non-Compliance Marks Post-Brexit

The European Medicines Agency said it may become more difficult for UK firms to have GMP non-compliance statements lifted following Brexit. Read More

New International Deal Lowers Price of Generic HIV Regimen to $75 Per Year

A new pricing agreement will allow a leading HIV regimen to be rolled out in more than 90 low- to middle-income countries, at an average cost of $75 per patient, per year. Read More

EMA’s Exodus From London Could Hit Staff Hard, Internal Survey Shows

The European Medicines Agency stands to lose nearly one-fifth of its staff when it leaves London, no matter which city in the European Union is selected for its new headquarters, a survey of the EMA workforce showed. Read More

EMA Updates Advice on CHMP Opinions on Products for Non-EU Countries

The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Read More

EMA to Update ICH Guidelines on Trial Statistics, Reproductive Toxicology

The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on measuring drug risks to human reproduction. Read More

EMA Delays Publication of Clinical Study Reports

The European Medicines Agency hit a snag in its efforts to publish clinical trial data reports, due to long pilot phases for the first publications it made after the policy took effect last October. Read More

EMA Launches New Form for Submitting Required Postmarket Data

The European Medicines Agency is implementing a new form to submit required postmarket data on safety, efficacy and quality, and it is now a mandatory part of Module 1.0 of the electronic common technical document format. Read More

ICH Finalizes Q&A Doc on Justifying Drug Starting Materials

The ICH finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More

FDA Updates ICH Quality Testing Guidance to Include Health Canada

The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More