International Pharmaceutical Regulatory Monitor
October 2012 | Vol. 40 No. 10 | Full Issue in PDF Format
An Indian panel of government health ministers has recommended price controls be applied to all 348 generic drugs on the country’s essential generic drugs list.
Distributors of biological products must maintain records of temperature monitoring data and check temperatures during transport and storage at defined intervals, according to a draft guidance by India’s Central Drugs Standard Control Organization (CDSCO).
While most Southeast Asian nations have laws spelling out the kinds of gifts and payments drugmakers can and cannot make to local healthcare providers, many struggle to enforce them when companies cross the line, experts say.
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) cited increasing regulatory cooperation with China and South Korea in saying it will now accept new drug applications that rely on well-designed, well-conducted global clinical trials in the neighboring East Asian nations. Includes the full text of Japan’s Basic Principles on Foreign Clinical Trials.
Drugmakers that are found to have violated China’s safety laws will now be blacklisted and their names published on the State Food and Drug Administration (SFDA) website.
In response to the rapid rise in counterfeits, the International Organization for Standardization (ISO) has issued a new industrywide standard to help ensure the life-cycle integrity of products.
Mexico’s drug regulator Cofepris has doubled its clinical trial protocol review timeline, with approvals coming in six months now instead of three, an expert says.
CHICAGO — U.S. manufacturers looking to import their drugs to Latin America are finding that the greatest challenges are capacity-related, as more narrow-bodied aircraft are now flying south, an expert says.
Manufacturers withdrawing their drugs from any market in the EU will now have to notify competent authorities of the reason, according to amended pharmacovigilance rules adopted by the Council of the European Union Oct. 4.
Manufacturers of transdermal patches should minimize the amount of residual drug substance in the patch as much as possible to avoid patient and environmental safety risks, according to a new European Medicines Agency (EMA) draft guideline.
The European Medicines Agency (EMA) will soon allow biosimilars sponsors to reference biologics made outside the European Economic Area (EEA) in some preclinical and clinical studies required for approval.
Health Canada has expanded the scope of a pilot project that uses foreign drug reviews to aid in its assessment of new drug submissions, also revising the draft guidance under which the pilot operates.
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