Posts Tagged ‘foreign clinical trials’

France issues stricter rules for pharma trials

lab_franceThe French government took measures last week to lower the health risks to clinical trial participants following the final report regarding a phase 1 clinical trial that killed one person and hospitalized five others in January. France’s health minister Marisol Touraine presented a plan on Monday for stricter rules regarding human drug trials. The plan also requested the Rennes-based Biotrial CRO that conducted the trial to submit a “plan of action” within a month to explain how it will avoid a repeat of these or else lose its operating license.

The report, issued by France’s General Inspectorate of Social Affairs (IGAS), also calls on the government to “mobilize the international scientific community” to find out what went wrong and suggests a range of scientific approaches, such as testing whether the drug hits other brain targets than the intended one and a study of the potential toxicity of the compound’s metabolites. Read more…

New insurance template for Swiss clinical trials

October 2, 2015 Leave a comment

clinicalTrialsThe Swiss Ethics Committees on research involving humans has recently released a new certificate of insurance/policy template that insurers must follow. As part of this new format, the Committee now requires the insured risk be categorized as category A, B, or C as outlined by Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance; ClinO) of September 20, 2013 (Status as of January 1, 2014). Insurers do not have the descriptions for the classifications, and are prohibited from providing advice regarding categorization of a trial. Sponsors or their CROs must seek advice from the Swiss Ethics Committees on research involving humans to determine the appropriate classification for their trial. Categorization of the trial is required before the certificate of insurance meets the requirements of the Human Research Act (HRA) and the Ordinance on Clinical Trials in Human Research (ClinO) can be issued. Certificates cannot be issued without the categorization of the Insured risk. Read more…

FDA officials warn drug makers: comply or face sanctions

indiadrugsHaving already faced serious legal threats from regulatory agencies last year, India’s pharmaceutical industry is now under additional scrutiny from the U.S.  Food and Drug Administration officials are intensifying investigations into the country’s drug facilities.  In February, this FDA Commissioner Margaret Hamburg met with Indian officials about the safety of Indian drug plants, following multiple reports that the country has sold fake pharmaceutical drugs and produced falsified drug test results.

India is currently the second largest exporter of over-the-counter prescription drugs to the U.S. and supplies 40 percent of generic prescription drugs to American consumers. The country exports about $15 billion in drug products each year and while many Indian manufacturing facilities are of top quality, others are in poor condition. The World Read more…

Stricter standards for India’s clinical drug trials

January 16, 2013 1 comment

supreme court of india_5Following allegations against pharmaceutical multinational companies (MNC’s) for using humans as guinea pigs to conduct illegal clinical trials, India’s Supreme Court has ordered that all clinical drug trials be performed under the Centre Health Secretary. Earlier this month, the apex court accused the Health Ministry of ignoring the issue and failing to put proper mechanisms in place to control illegal trials that have caused the deaths of more than 2,242 deaths in the last five years. The court slammed the government’s past attempts to crack down on the various pharmaceutical companies, saying little had been done to remedy the problem, and gave the Ministry four weeks to address to the matter. The bench did, however, refrained from passing any blanket ban on the trials and, instead, sought a comprehensive reply from the Centre on various issues.

In response, the government said it plans to regulate the $500 million sector by amending drug laws to include stricter guidelines for pharma MNC’s and increasing compensation payments Read more…

Costs and larger trials among the factors driving the globalization of clinical trials

December 7, 2010 Leave a comment

Although significant drug and medical device R&D activity remains within the United States, representing close to 50% of total worldwide expenditures over the last 10-15 years, a clear trend toward globalization has emerged. Many would argue that cost is the primary factor driving this development, however, research suggests that other key factors are contributing as well. Some of these factors include an overall increase in R&D activity, lower enrollment rates in developed countries, and larger trials. It is currently estimated that 50% of all pivotal clinical studies contain data from foreign trials.

We see many drug and medical device companies go overseas to supplement or use as a substitute for U.S. based studies, what surprising is that Western Europe is no longer the only destination. Read more…

Pending changes to insurance standards for Russian clinical trials

August 31, 2010 3 comments

Effective 9/1/10, there are changes to the Federal Drug Law pending in Russia that will have a material effect on the approval and management of clinical trials that are being conducted there. The changes are related to the regulatory approval process being transferred from the Federal Service on Surveillance in Healthcare and Social Development to the Ministry of Health and Social Development. The majority of this criteria is related to investigator sites, mainly to contracts with investigators, investigator experience, patient consents and insurance amounts. Unfortunately, the current version of the law is full of inconsistencies and requires further clarification. Many CROs are still evaluating how these changes will affect studies (specifically on start-up operations) and continue to report any new developments. The relationship between the Insurer, Insured (sponsor) and the Patient (test subject) will be defined in these new proposed regulations which are still pending approval by the Government of the Russian Federation. At this time no such “regulations” have been approved and this continues to be closely monitored.

New legal requirements for conducting clinical trials in Italy

March 12, 2010 Leave a comment

Italy Clinical TrialsA decree goes into effect March 14th requiring minimum insurance for any company conducting clinical trials in Italy. The new requirements were established by Italy’s Ministry of Labor, Health and Social Policy to safeguard participants in clinical trials conducted wholly or in part in that country.

The requirements state that the insurance policy must cover any civil liability of the sponsor and investigator without excluding any damage which may have been caused by accident or attributed to negligence. In addition to death and permanent and/or temporary injury, damages include economic loss directly resulting from participation in the clinical trial. Read more…