International Pharmaceutical Regulatory Monitor

The EU is drying up the overseas supply of execution drugs by imposing strict export controls on all drugs that could be used in lethal injection — a move that could further exacerbate U.S. shortages of the anesthetics. Includes the full text of EU Regulation on Death Penalty Meds.

Drugmakers testing drugs’ genotoxicity should consider the sum of the test results, as well as the intrinsic limitations of in vitro and in vivo tests, according to a revised European Medicines Agency (EMA) guideline.

The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) plan to step up cooperation on good manufacturing practice (GMP) inspections, moving from information-sharing and joint inspections to outright reliance on one another’s results.

Tanzania’s Food and Drugs Authority (TFDA) has issued draft guidelines for sponsors, investigators and contract review organizations on reporting safety data and compensation in clinical trials.

Sponsors must ensure the stability of investigational drug products before beginning clinical trials and bioequivalence studies in India, according to the Central Drugs Standard Control Organization (CDSCO).

Australian drugmakers have agreed to a new round of market-based price cuts that will lower the cost of off-patent medicines on average 23 percent, beginning April 1.

Drug advisory committee members should disclose any potential conflict of interest prior to each meeting, according to a final guideline by Australia’s Therapeutic Goods Administration (TGA).

Drug importers must certify that foreign manufacturers adhere to good manufacturing practice (GMP) before a product can be registered in the Philippines, according to a draft guideline.

Patent reform in the U.S. and EU, pricing pressures in numerous countries, increasing competition from emerging markets in Asia and Latin America and the global offensive against fake drugs. IPRM followed these issues and more to ensure that readers have the information they need to make smart business decisions in the U.S. and abroad. Here are some of the highlights of 2011 and a foreshadowing of challenges in the year ahead.

The U.S. Food and Drug Administration (FDA) Dec. 16 issued an interim final rule requiring drugmakers to report interruptions in the production of critical drugs.

The U.S. Food and Drug Administration (FDA) is using a decisionmaking matrix to weigh expected clinical benefits for biopharmaceuticals against their risks in a pilot program using six new molecular entity applications under review.

Drugmakers responding to unsolicited requests for off-label product information are urged to keep conversations private and specific to the requester’s inquiry, according to a new draft U.S. Food and Drug Administration (FDA) guidance.

In response to a citizen petition, the U.S. Food and Drug Administration (FDA) is seeking public input on how it should regulate scientific exchanges on off-label uses for medical products.