Role of Regulatory Authorities

Government bodies have on occasion accelerated clinical trials against advice from researchers, in response to public demands (Exhibit 6.11). The climate today is that due diligence regarding safety has to be performed before the drug is administered to human subjects and that clinical trial submissions have to be approved by the regulatory authorities before the trial commences. 

In the 1950s, Dr. Jonas Salk and Dr. Albert Sabin from the University of Pittsburgh in the US worked on polio vaccines. Salk used inactivated polio virus, whereas Sabin developed a live form of polio virus. 

Scientists differed as to which method provided the better vaccine. Both Salk and Sabin agreed that more tests were needed before a mass vaccination program could begin. 

The National Foundation, which funded the research, and the American public wanted a mass vaccination urgently. The average incidence of polio in the US in 1949-1953 was 25.7 cases per 100 000 children. The National Foundation ordered 27 million doses of the Salk vaccine for a trial, and close to one million children were vaccinated (749 236 children from Grades 1,2 and 3 were offered vaccine, and 401 974 completed the trial). 

The trial was one of the greatest triumphs in medical history. Church bells rang across the country when the trial results were announced. Within five years, polio was wiped out from the US. 

6 India s Central Drugs Standard Control Organization 

10 Authorities Other than Drug Regulatory Agenoies 

Regulatory authorities perform the watchdog role to ensure that animal studies comply with Good Laboratory Practice (GLP), clinical trials are 

Thalidomide was synthesized in Germany and became available in late 1957. It was prescribed for the treatment of insomnia and nausea in pregnant women. 

However, it had not been discovered that the thalidomide drug molecule could cross the placental barrier and affect fetal development. As a result, thousands of babies were born with crippled extremities, disfigurement, and disabilities. Numerous fetuses were stillborn or died soon after birth. 

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The intention of this book is to provide an overview of how a drug is discovered, the amount and types of laboratory tests that are performed, and the conduct of clinical trials before a drug is ready to be registered for human use. Of importance is the role of regulatory authorities in these processes. Through... 

In all this, it should be remembered that the role of regulatory authorities is to protect the public. For entirely justifiable reasons, they will apply very strict criteria to products with a low therapeutic index, non-linear kinetics or imfavour-able physical properties. Digoxin, phenytoin and primidone provide notable examples of drugs where bioinequivalence issues have led to clinical problems. 

This Section presents NCRP s recommendations on a framework for a comprehensive and risk-based hazardous waste classification system. These recommendations focus primarily on the concepts and principles embodied in the new system. Approaches to implementing the waste classification system by specifying quantitative boundaries of different waste classes in the form of limits on concentrations of hazardous substances are discussed in this Section and in Section 6.4.5, and numerical examples are developed in Section 7.1. However, NCRP believes that the task of specifying such boundaries is properly the role of regulatory authorities, and specific recommendations on limits on concentrations of hazardous substances in different waste classes are not presented. 

The consumer movement, particularly the Consumers Health Fomm, also has considerable political influence. As a result of political pressure exerted by HIV/AIDS pressure groups and industry, the DRA was reviewed, new legislation introduced and new committees established to ensure that the regulatory authority responded more efficiently to public and political needs. Professional associations, especially the Pharmacy Guild of Australia, have traditionally played an active role in decisions related to pharmaceutical regulation. The Australian Pharmaceutical Advisory Council was established by the Australian Government to advise the Commonwealth Minister for Health on pharmaceutical policy. 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

Regulatory authorities play an important and active role to ensure regulatory compliance in the conduct of a clinical trial. Agencies such as the FDA inspect clinical studies. An inspection of a trial may reveal that the protocol is not being followed strictly, the Investigator may not be involved with the project as much as is expected, there may be a lack of patient care, changes to the protocol may not have been relayed to the IRB, and so on. In such cases, corrective actions have to be implemented immediately and the FDA must be satished before the trial can continue. Deficiencies found are reported on Form 583. 

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