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Internationalpharmaceuticalregulatorymonitor

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March 2014

Vol. 42
No. 3

Headlines

EU Industry Calls for More Dialogue on Proposed Pharmacovigilance Fees

Drug companies could pay as much as US $330,000 per authorized product to cover postmarketing assessments required by the EU’s new pharmacovigilance law, under fees proposed by European lawmakers. Read More

EMA Vigilance Guideline Encourages Range of Educational Materials

The European Medicines Agency is advising drugmakers to create a separate program to assess the effectiveness of risk-minimization efforts for each marketed drug. Read More

FDA, EMA Form Pharmacovigilance ‘Cluster’ to Enhance Drug Safety

The U.S. Food and Drug Administration and European Medicines Agency have launched a new information-sharing initiative aimed at speeding international responses to drug safety problems. Read More

EMA Stresses Testing of Porcine-Derived Starting Materials to Protect Supply Chain

Drugmakers should test porcine trypsin, a starting material used in biologic drugs, just after it is produced to ensure material from a single infected pig doesn’t enter production batches, the European Medicines Agency says. Read More

U.S. Drug Commissioner’s India Trip Includes Signing of Five-Year Accord

U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products. Read More

MHRA Reports Uptick in Drug Ad Complaints, Focuses on Education

The UK’s Medicines and Healthcare products Regulatory Agency recorded a nearly 20 percent increase in complaints about drug advertisements in 2013 — the majority coming from companies complaining about their competitors. Read More

EMA Requires Drugmakers to Obtain Numerical Code for All New Drugs

Sponsors seeking marketing authorization for new drugs in the EU must now apply for a numerical code unique to the submission, the European Medicines Agency says. Read More

Australian Regulators Launch New Electronic Drug Submission System

Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format only, allowing for cost savings and potentially swifter reviews. Read More

PhRMA Takes Concerns About EU Transparency Plan to U.S. Trade Chief

PhRMA has asked the Office of the U.S. Trade Representative to put the EU on notice for its plan to publish clinical trial data that currently is treated confidentially. Read More

EMA Outlines Scenarios for Exploratory Investigations of Trial Subpopulations

Sponsors may be asked to provide the European Medicines Agency with additional data from failed trials to hone in on subpopulations where the treatment may be effective. Read More

India Publishes Drugmaker Payouts for Clinical Trial-Related Deaths

India’s Ministry of Health and Family Welfare has begun publishing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial. Read More

CDSCO Offers Guidance on Approval of Stem Cell/Cell-Based Products

Manufacturers of stem cell and cell-based products (SCCPs) should perform stability tests during early phases of clinical trials to establish the products are sufficiently stable for the period required by the study, a draft guidance by India’s Central Drugs Standard Control Organization advises. Read More

Indian Regulator Outlines Shelf-Life Requirements for Imported Drugs

India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, the Central Drugs Standard Control Organization said Feb. 13. Read More