International Pharmaceutical Regulatory Monitor
June 2012 | Vol. 40 No. 6 | Full Issue in PDF Format
A number of drugmakers in China are being ordered to power down production lines and hand over their licenses for producing capsule-based drugs after a crackdown on chromium contamination by the country’s regulatory agency.
Stung by the chromium-contaminated drug capsule scandal, China’s State Food and Drug Administration (SFDA) is proposing to “blacklist” executives who oversee pharma companies found to produce substandard or counterfeit drugs.
The overall number of adverse drug events in China in 2011 remained level with 2010, but reporting by individual municipalities increased, according to the State Food and Drug Administration’s (SFDA) 2011 annual report on adverse drug reaction (ADR) monitoring.
Drugmakers breaking into emerging markets could see supply chain benefits and quicker product launches if these markets automatically registered U.S. Food and Drug Administration (FDA)-approved products before testing for quality issues, according to a new study.
As developed countries like the U.S. and EU look to combat counterfeit medicines, they may want to consider Turkey’s track-and-trace system, which in a little more than two years has helped pull more than 140 million illicit drug packages from the country’s market.
The EU Ombudsman June 4 criticized the European Medicines Agency’s (EMA) lack of transparency and guidelines for deciding when to require drugmakers to carry out pediatric clinical trials.
Biosimilars’ molecular characteristics should mirror those of the reference biologic as closely as possible, while the performance and consistency of the biosimilars’ manufacturing process should stand on its own, the European Medicines Agency (EMA) says in an updated guideline. Includes the full text of EMA Guideline on Biosimilar Quality Comparisons.
The European Medicines Agency (EMA) has updated its draft guideline on clinical investigations of venous thromboembolism (VTE) products, adding new definitions for bleeding events and secondary endpoints to consider for clinical trials.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use is seeking public input as it works to update its points-to-consider document on multiplicity issues in clinical trials.
Drugmakers now need to get government approval in France before advertising their products to health professionals and the general public, thanks to a decree that took effect May 9.
Citing a spike in internet advertising of drugs and medical devices, Australia’s Therapeutic Goods Administration (TGA) is proposing adding online promotions to its definition of mainstream media ads that require prior approval.
Drug and medical device companies and some local government officials are urging Health Canada to expand its summary basis of decision (SBD) initiative so product approval reports are published more quickly and on a wider range of products.
The U.S. Food and Drug Administration (FDA) is approving drugs faster than its regulatory peers in Europe and Canada, a new study finds, challenging criticism that the U.S. agency harps on safety at the expense of timely reviews.
The U.S. Food and Drug Administration (FDA) will likely take its time adopting an International Conference on Harmonisation (ICH) guideline that recommends drugmakers use risk assessments to identify material and process characteristics that could alter the critical quality attributes (CQAs) of active pharmaceutical ingredients (APIs).
The U.S. Pharmacopoeial Convention (USP) and British Pharmacopoeia (BP) have developed two drug product quality standards under a new, flexible approach that signals a drive toward speedier and more creative harmonization — and a potential break for drugmakers.
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