International Pharmaceutical Regulatory Monitor
November 2010 | Vol. 38 No. 11 | Full Issue in PDF Format
Medicines Australia has fined several drugmakers for misleading advertising and/or breaching its code of conduct, including a $200,000 fine to Roche for making misleading claims about its anemia drug Mircera.
The UK’s National Institute for Health and Clinical Excellence (NICE) will continue to have “an important advisory role” in the evaluation of drugs and health technologies under a new value-based pricing initiative but will no longer be key to whether a particular drug receives government funding, according to a high-ranking National Health Service official.
The European Medicines Agency (EMA) will assign a risk level to potential conflicts of interest for outside scientific experts and use this to restrict their activities with the agency as needed, according to an updated policy on handling conflicts of interest. Includes the full text of European Medicines Agency Policy on Conflicts of Interest.
Reports of suspected unexpected serious adverse reactions (SUSARs) occurring in clinical trials in the European Economic Area will soon have to include an assessment of any drug or drugs suspected of playing a role in the event, according to final guidance by the European Medicines Agency (EMA).
The European Medicines Agency (EMA) received 75 percent more requests for good clinical practice and pharmacovigilance inspections than anticipated for the first half of 2010, in part due to better information sharing with the U.S. Food and Drug Administration, the EMA says in a mid-year report.
New Zealand’s drug-purchasing agency Pharmac has agreed to fully reimburse patients who use Pfizer’s smoking cessation drug Champix despite earlier concerns about the drug’s safety.
The UK’s coalition government will seek other ways of driving the use of generic drugs that are more acceptable to patients, rather than requiring pharmacists to substitute generics for brand-name drugs used in primary care. Includes the full text of UK Department of Health Report on Generic Substitution.
Australia’s Therapeutic Goods Administration (TGA) has issued guidance for drugmakers on transitional mandatory requirements for an effective submission under the streamlined submission process.
India’s Central Drugs Standard Control Organization (CDSCO) hopes to improve approval times for the importation, manufacture and marketing of new drugs by adopting the common technical dossier (CTD) format for new drug applications.
Australia’s Department of Health and Ageing (DoHA) is seeking feedback on information related to health technology assessment (HTA) reviews of proposed in vitro diagnostic (IVD) tests and drugs that depend on each other for optimal clinical and economic effectiveness.
The U.S. Food and Drug Administration (FDA) will merge two guidances — a draft guidance on developing diabetes drugs and a final guidance on evaluating risk in those drugs — and issue a combined document for industry.
As the participating countries draw to a close their negotiations for the Anti-Counterfeiting Trade Agreement (ACTA), new voices are speaking out over concerns about the effect the agreement could have on drugmakers.
U.S. Food and Drug Administration (FDA) inspection of foreign plants has increased in recent years but still pales in comparison to the level of inspections made on U.S.-based manufacturing facilities, the U.S. Government Accountability Office (GAO) has found.
Better coordination between the U.S. Food and Drug Administration’s (FDA) overseas offices and their domestic counterparts as well as long-term strategic planning is needed to improve the role of those offices in the face of the growing challenge of import safety, according to the U.S. Government Accountability Office (GAO).
A major international offensive against online sellers of counterfeit and illicit medicines has resulted in the seizure of more than one million pills with an estimated value of $2.6 million.
Individual officers and managing employees at pharmaceutical companies can be labeled as criminals and potentially forced out of the industry because of someone else’s misconduct, according to a new guidance from the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG).
There are at least three exceptions that allow sponsors to conduct human clinical trials without an IND submission, the U.S. Food and Drug Administration (FDA) says in a draft guidance designed to clear up confusion and misperceptions about IND exemptions.
Drugmakers should work together to get U.S. Food and Drug Administration (FDA) qualification for drug development tools (DDTs), which can then be used to aid in development and review of multiple companies’ drugs, a new draft guidance advises.
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