Regulatory authorities costs

The TGA in Australia, the MEB in the Netherlands and the Medicines Control Agency in Zimbabwe are financed entirely by the fees and charges they collect. Unlike the countries mentioned above, these dmg regulatory authorities have full powers to dispose of the revenue they collect. And because their financial viability depends on the revenue they generate, fees and charges reflect the real cost of services. 

ISO has two important functions in analytical chemistry. The first is to publish descriptions of accepted methods. These are effectively industry standard methods for particular protocols. The second is in laboratory accreditation. For a laboratory to be ISO accredited, compliance with international QA standards must be confirmed by an initial assessment and subsequently from repeated audits by an independent assessor. Since ISO has no legal or regulatory powers, the standards are voluntary. It is unlikely, however, that a forensic analysis which did not conform to an ISO standard would be upheld in court, for example. Most commercial laboratories need to be accredited to remain competitive and to deal with regulatory authorities. Most university labs are not accredited, mainly due to the time and costs involved, and also to the nonroutine nature of much university research. However, university accreditation may become a requirement in the near future, especially for publicly funded research in the UK. The details of laboratory accreditation are discussed by Christie et al. (1999) and Dobb (2004). 

The CTDs were implemented in July 2003. They are format-based documents for submission to the regulatory authorities the country-specific process of review, for example, via the IND and NDA of the United States or the Centralized Procedure of the EMEA, is not affected. The harmonized CTDs help to reduce cost and accelerate approval time. Figure 7.1 shows the CTD structure five modules with Module 1 for regional administrative information specihc to each country. Module 2 on summary of quality, nonclinical and clinical. Module 3 on quality. Module 4 on nonclinical study reports, and Module 5 on clinical study reports. 

If national regulatory authorities can rely on safety test data developed abroad, duphcative testing can be avoided and costs saved to government and industry. Furthermore, a reduction in the number of laboratory animals used for testing of chemicals is an important goal in relation to animal welfare. 

A large proportion of the technology appraisals so far performed by NICE on pharmaceuticals have been on products recently introduced into the marketplace. This has created difficulties for manufacturers trying to answer the questions posed by the appraisal. For most compounds, at the time of launch it is very unlikely that outcome studies will have been completed that allow accurate cost effectiveness calculations to be performed. The emphasis in Phase III is on clinical efficacy and safety to satisfy the requirements of the regulatory authorities. In most cases, it is impossible (and probably imethical) to perform pragmatic studies on the general population imtil safety and efficacy have been satisfactorily demonstrated in a tightly defined trial population. 

The investigator should prepare an informed consent form for every study to be performed at the institute and should obtain an approval by the IRB that covers the institute. GCP listed a dozen points to be covered by the informed consent (1C) form (see Table 23.6). The new GCP allows a reasonable amoimt of pa)unent to the patient, such as transport cost. Patients should allow clinical trial monitors, auditors, IRB members and inspectors from the regulatory authority to verify the source documents. This new requirement of obligatory written 1C is regarded as a... 

The assessment of the clinical benefit of medicines is generally understood by clinicians, regulatory authorities and reimbursement authorities alike. Everyone instinctively understands the clinical benefit of decreasing a hypertensive patient s blood pressure to 130/90 or the benefit in reducing the number of strokes. However, in an era of increasing healthcare costs and funding decisions, there is a need not only to illustrate the clinical benefit of a drug, but to translate that clinical outcome into an economic benefit. 

End use is an important parameter because remediating JACADS to a residential standard typically would be more difficult than remediating the site to an industrial standard. The Army has favored an industrial standard, because the decision on which standard will be used and permitted by regulatory authorities may also set an important precedent for the closures (and costs) of other chemical agent disposal facilities. 

---